[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tianjin Medical University Cancer Institute and Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":545},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,211,0,25,[9,43,61,80,107,130,152,175,195,216,239,263,279,303,327,347,366,387,407,427,453,472,489,508,527],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100652963","phase-2-thiotepa-administration-via-ommaya-reservoir-for-leptomeningeal-metastases-in-non-small-cell-lung-cancer-resistant-to-egfr-tki-100652963",false,"NCT07778940","Thiotepa Administration Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI.","A Single-Arm Phase II Study of Intrathecal Thiotepa Via Ommaya Reservoir for Leptomeningeal Metastases in Non-Small Cell Lung Cancer Resistant to EGFR-TKI","LEP-THP-2026","Inclusion Criteria:\n\n1. Age between 18 and 75 years.\n2. Male or female of non-childbearing potential, or female of childbearing potential who is not pregnant or lactating.\n3. ECOG performance status of 0 to 2, with no deterioration within the past 7 days.\n4. Radiological and\u002For cerebrospinal fluid (CSF) cytological evidence of leptomeningeal metastases (LM). The diagnosis of non-small cell lung cancer (NSCLC) must be confirmed by histological and\u002For cytological examination.\n5. Patients must meet at least one of the following criteria: failure of first- or second-generation TKI therapy with T790M mutation negative; failure of third-generation TKI therapy; or EGFR mutation negative with failure of first-line therapy.\n6. If concurrent brain parenchymal metastases are present, they must have received appropriate treatment or been evaluated as stable over the past three months. Additionally, extracranial lesions must be evaluated as stable under the current treatment regimen.\n7. Adequate organ and bone marrow function, as evidenced by the following laboratory parameters: HGB ≥ 90 g\u002FL; NEUT ≥ 1.5 × 10⁹\u002FL; PLT ≥ 80 × 10⁹\u002FL; TBIL ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (if liver metastases are present, ALT and AST ≤ 5 × ULN); creatinine clearance ≥ 50 mL\u002Fmin (calculated by the Cockcroft-Gault formula); urine protein \\\u003C (++) or 24-hour urine protein \\\u003C 1.0 g; normal coagulation function without active bleeding; INR ≤ 1.5; APTT ≤ 1.5 × ULN.\n8. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must voluntarily use adequate contraception during the study period and for 8 weeks after the last dose of the study drug. Males must be surgically sterilized or agree to use adequate contraception during the study period and for 8 weeks after the last dose of the study drug.\n9. Prior Ommaya reservoir implantation.\n10. Estimated life expectancy of ≥ 12 weeks.\n11. No history of severe neurological diseases or severe hematological abnormalities.\n12. Patients who have received prior brain and\u002For spinal cord radiotherapy, including stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT), are eligible, provided that radiotherapy was completed at least 7 days prior to the initiation of study treatment.\n13. Concurrent intrathecal therapy with other agents is prohibited. For patients who have received other systemic therapies, the minimum washout periods are as follows: patients who have received prior intrathecal therapy must complete the last treatment at least 7 days before initiating study treatment; patients who have received systemic chemotherapy must complete the last treatment at least 14 days before initiating study treatment; patients who have received approved systemic immunotherapy (e.g., anti-PD-1, anti-CTLA-4) must complete the last treatment at least 14 days before initiating study treatment; patients who have received any other investigational drugs must complete the last treatment at least 14 days before initiating study treatment.\n14. Ability to provide written informed consent, including compliance with the requirements and restrictions listed in the informed consent form. Patients must have good compliance, voluntarily agree to participate in the clinical study, sign the informed consent form, and be willing to cooperate with follow-up visits.\n\nExclusion Criteria:\n\n1. Patients requiring ventriculoperitoneal (VP) shunt placement due to elevated intracranial pressure.\n2. History of epilepsy unrelated to leptomeningeal metastases.\n3. Evidence of any neurological functional failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy as shown on imaging, or a Glasgow Coma Scale (GCS) score \\\u003C 11.\n4. Evidence of any extensive and fatal progressive systemic disease with no effective treatment available.\n5. Prior allogeneic bone marrow transplantation or solid organ transplantation. Uncontrolled hypertension prior to enrollment, defined as: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg.\n6. Surgical procedures involving vital organs within 3 months prior to enrollment.\n7. Any disease or condition prior to enrollment that affects drug absorption. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification \\> Grade 2; ventricular arrhythmias requiring medication; left ventricular ejection fraction (LVEF) \\\u003C 50%; or other related diseases such as severe pulmonary, hepatic, or renal dysfunction, severe gastrointestinal ulcers, or coagulation dysfunction.\n8. Active or uncontrolled severe infections (≥ Grade 2 infections per CTCAE v5.0).\n9. Known human immunodeficiency virus (HIV) infection. Known history of clinically significant liver disease, including viral hepatitis \\[Known hepatitis B virus (HBV) carriers must be excluded if they have active HBV infection, defined as HBV DNA positive (\\>1×10⁴ copies\u002FmL or \\>2000 IU\u002FmL); known hepatitis C virus (HCV) infection with HCV RNA positive (\\>1×10³ copies\u002FmL)\\].\n10. Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory abnormalities that, in the investigator's judgment, provide reason to suspect a disease or condition that makes the patient unsuitable for the study drug (e.g., seizures requiring treatment), will affect the interpretation of study results, or place the patient at high risk.\n11. Patients with a prior history of basal cell or squamous cell skin cancer, cervical carcinoma in situ, or other cancers may be considered for enrollment if there is evidence of being disease-free for more than 5 years after treatment.\n12. Severe neurological or psychiatric history; active disseminated intravascular coagulation (DIC); or other concomitant diseases that, in the investigator's judgment, seriously jeopardize patient safety or affect the patient's ability to complete the study.\n13. Participation in other clinical trials, receipt of investigational drugs, or any concomitant treatments containing investigational drugs within 14 days prior to enrollment.\n14. Patients deemed unsuitable for this study by the investigator.","ALL","18 Years","75 Years",{"count":22,"type":23},50,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The goal of this clinical trial is to learn if the Thiotepa administration via Ommaya Reservoir works to treat non-small cell lung cancer with leptomeningeal metastases resistant to EGFR TKI. The main questions to answer are:\n\nIs Thiotepa administration via Ommaya Reservoir safe to inject? How effective is thiotepa via Ommaya Reservoir in intracranial-disease control? Participants will：\n\nStage 1: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, twice every week, for 4 consecutive weeks; Stage 2: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once every week, for 4 consecutive weeks; Stage 3: Intrathecal injection of 10 mg thiotepa via Ommaya reservoir, once a month, for 4 consecutive months; Before each intrathecal administration, a preliminary intrathecal injection of dexamethasone, 2.5 mg\u002Fdose, is given.",[29],"Leptomeningeal Metastasis","NOT_YET_RECRUITING","2026-08-19",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":23},"2026-09",{"date":38,"type":23},"2028-03",{"name":40,"class":41},"Tianjin Medical University Cancer Institute and Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":49,"targetDuration":4,"studyType":24,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":4},"100652885","phase-2-a-prospective-phase-ii-clinical-trial-evaluating-the-efficacy-and-safety-of-adebrelimab-in-combination-with-trastuzumab-rezetecan-for-patients-with-stage-iii-unresectable-her2-positive-nsclc-100652885","NCT07778745","A Prospective Phase II Clinical Trial Evaluating the Efficacy and Safety of Adebrelimab in Combination With Trastuzumab Rezetecan for Patients With Stage III Unresectable HER2-Positive NSCLC","Inclusion Criteria:\n\n* Aged 18-75 years, male or female.\n* Histologically or cytologically confirmed stage III unresectable NSCLC per AJCC 9th edition, judged unresectable by institutional MDT team.\n* Confirmed HER2 alteration: HER2 mutation\u002Famplification detected by tissue NGS, or HER2 protein overexpression (IHC 2+ or 3+).\n* No prior systemic anti-tumor therapy for NSCLC; prior anti-tumor Chinese herbal medicine allowed if ≥2 weeks washout before first dose.\n* At least 1 measurable target lesion per RECIST v1.1.\n* ECOG performance status 0 or 1.\n* Able to provide tumor tissue specimen (archival ≤6 months or newly biopsied non-irradiated lesion).\n* FEV1 \\>1.0 L and FEV1% predicted \\>40% within past 3 months.\n* Adequate organ function within 7 days before first dose (no blood product\u002FG-CSF support within 14 days):\n\n  * Hematology: WBC ≥3.0×10⁹\u002FL, ANC ≥1.5×10⁹\u002FL, PLT ≥100×10⁹\u002FL, Hb ≥90g\u002FL\n  * Liver: AST\u002FALT ≤2.5×ULN (≤5×ULN for liver metastasis), TBIL ≤1.5×ULN\n  * Renal: Serum Cr ≤1.5×ULN or CrCl ≥50 mL\u002Fmin\n  * Cardiac: LVEF ≥50% by echocardiogram\n* Fertile male\u002Ffemale participants must use effective contraception during treatment and 6 months after last dose; female participants non-lactating, negative serum HCG within 14 days pre-first dose.\n* Voluntarily sign written informed consent, good compliance for follow-up.\n\nExclusion Criteria:\n\n* Mixed small cell\u002Flarge cell neuroendocrine\u002Fsarcomatoid NSCLC histology.\n* Concurrent other actionable driver gene alterations (EGFR, ALK, MET, BRAF, RET etc.) besides HER2.\n* Past or concurrent other malignant tumor (except fully resected cancer ≥5 years without active treatment).\n* Prior thoracic radiotherapy.\n* Major surgery within 28 days or minor invasive surgery within 7 days before first dose.\n* HIV infection, active hepatitis B\u002FC, organ transplant history, congenital\u002Facquired immunodeficiency.\n* Systemic immune modulators (thymosin, interferon, IL-2) within 4 weeks pre-enrollment.\n* Uncontrolled severe cardiovascular disease, unstable angina or intervention-required ventricular arrhythmia within 1 month.\n* Confirmed or suspected interstitial lung disease, severe baseline pulmonary dysfunction interfering with lung toxicity monitoring.\n* Active uncontrolled ≥2 grade infection within 2 weeks before enrollment.\n* Active tuberculosis under treatment.\n* Known hypersensitivity to any component of study drugs or other monoclonal antibodies\u002Ffusion proteins.\n* Any condition judged by investigator to compromise participant safety or trial compliance.",{"count":50,"type":23},37,[26],"This is a single-arm, open-label, multicenter phase II investigator-initiated trial. The study aims to explore the efficacy and safety of Adebrelimab plus Trastuzumab rezetecan induction therapy in patients with stage III unresectable HER2-altered non-small cell lung cancer (NSCLC). Eligible patients receive 3-4 cycles Q3W induction combination therapy. After induction, patients will receive radical surgery or concurrent chemoradiotherapy via MDT evaluation, followed by consolidation therapy and long-term survival follow-up. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include surgical conversion rate, major pathological response (MPR), event-free survival (EFS), overall survival (OS), and safety profiles.",[54],"NSCLC",{"date":33,"type":34},{"date":57,"type":23},"2026-08-20",{"date":59,"type":23},"2029-08-30",{"name":40,"class":41},{"id":62,"slug":63,"hasResults":12,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":4,"eligibilityCriteria":67,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":24,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":74,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":4},"100652804","phase-2-adebrelimab-combined-with-dalpiciclib-isethionate-plus-chemotherapy-for-neoadjuvant-treatment-of-locally-advanced-head-and-neck-squamous-cell-carcinoma-100652804","NCT07778732","Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","A Prospective, Open-Label, Phase II Clinical Trial of Adebrelimab Combined With Dalpiciclib Isethionate Plus Chemotherapy for Neoadjuvant Treatment of Locally Advanced Head and Neck Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Patients aged ≥18 years;\n* Males or females who are not pregnant or breastfeeding;\n* ECOG performance status of 0-1, with no deterioration within the past 7 days;\n* Patients with histologically confirmed, locally advanced, resectable head and neck squamous cell carcinoma;\n* Patients who have not previously received any systemic treatment regimens for this cancer type;\n* Patients receiving neoadjuvant therapy must have evaluable lesions;\n* Adequate organ and bone marrow function, with laboratory test results meeting the following requirements:\n\n  1. HGB ≥ 90 g\u002FL;\n  2. NEUT ≥ 1.5 × 10⁹\u002FL;\n  3. PLT ≥ 80 × 10⁹\u002FL;\n  4. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);\n  5. ALT and AST ≤ 2.5 × ULN; in cases of liver metastases, ALT and AST ≤ 5 × ULN;\n  6. Endogenous creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula);\n  7. Urinary protein \\\u003C (++), or 24-hour urinary protein \\\u003C 1.0 g.\n* Normal coagulation function with no active bleeding\n\n  1. International Normalized Ratio (INR) ≤ 1.5;\n  2. Activated Partial Thromboplastin Time (APTT) ≤ 1.5 times the upper limit of normal (ULN).\n* Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must voluntarily use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 8 weeks after the last administration of the study drug.\n* Expected survival ≥ 12 months.\n* Patients must voluntarily enroll in this study and sign an Informed Consent Form (ICF).\n* Patients are expected to demonstrate good compliance and be able to follow up on efficacy and adverse reactions as required by the protocol.\n\nExclusion Criteria:\n\n* Previous receipt of any antitumor therapy for head and neck squamous cell carcinoma;\n* Administration of a live vaccine within 4 weeks prior to enrollment or likely to occur during the study period;\n* Active autoimmune disease or a history of autoimmune disease within 4 weeks prior to enrollment;\n* Previous allogeneic bone marrow or organ transplantation;\n* Uncontrolled hypertension prior to enrollment, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Any disease or condition prior to enrollment that affects drug absorption;\n* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Class \\>2 congestive heart failure; ventricular arrhythmias requiring medication; LVEF (left ventricular ejection fraction) \\\u003C50%;\n* Active or uncontrolled severe infection (≥CTCAE v5.0 Grade 2 infection); 9. Known human immunodeficiency virus (HIV) infection. History of clinically significant liver disease, including viral hepatitis \\[known hepatitis B virus (HBV) carriers must be free of active HBV infection, i.e., HBV DNA positive (\\>1×10⁴ copies\u002FmL or \\>2,000 IU\u002FmL); known hepatitis C virus (HCV) infection with HCV RNA positive (\\>1×10³ copies\u002FmL) ;\n* Any other disease, clinically significant metabolic abnormalities, physical examination abnormalities, or laboratory test abnormalities that, in the investigator's judgment, give reason to suspect that the patient has a condition or state that makes them unsuitable for the study drug (e.g., a history of epileptic seizures requiring treatment), or that will affect the interpretation of study results, or that places the patient at high risk;\n* Patients whom the investigator deems unsuitable for enrollment in this study.",{"count":69,"type":23},32,[26],"This single-center, open-label Phase II trial aims to evaluate the efficacy and safety of neoadjuvant combination therapy with Adebrelimab (anti-PD-L1), Dalpiciclib Isethionate (CDK4\u002F6 inhibitor), and cisplatin chemotherapy in patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC). A total of 32 eligible subjects will receive 2 cycles of triplet neoadjuvant treatment prior to radical surgery. The primary endpoint is the pathological complete response (pCR) rate following neoadjuvant therapy; secondary endpoints include major pathological response (MPR), objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), 1-year overall survival (1y-OS), and treatment-related adverse events (TRAEs). The exploratory objectives analyze correlations between biomarkers (oral microbiome, CDKN2A\u002FB deletion, CDK4\u002F6 amplification, and PD-L1 expression) and therapeutic efficacy or prognosis. Subjects will receive long-term tumor and survival follow-up after surgery until disease progression, death, loss to follow-up, or the end of study.",[73],"HNSCC",{"date":33,"type":34},{"date":76,"type":23},"2026-09-01",{"date":78,"type":23},"2028-09-01",{"name":40,"class":41},{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":88,"minAge":19,"maxAge":20,"enrollmentInfo":89,"targetDuration":4,"studyType":24,"phases":91,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":42},"100617622","phase-2-a-single-arm-phase--study-of-fluzoparib-maintenance-in-platinum-sensitive-advanced-triple-negative-breast-cance-100617622","NCT07321015","A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance","An Exploratory Single-Arm Study of Maintenance Fluzoparib in Platinum-Sensitive, Advanced Triple-Negative Breast Cancer Patients With BRCA1\u002F2 Mutation or Wild-Type BRCA","Fzp-MA-TNBC","Inclusion Criteria:\n\n1. Age 18-75 years (inclusive) at the time of informed consent.\n2. Histologically confirmed triple-negative breast cancer (TNBC; ER \\\u003C1%, PR \\\u003C1%, HER2-negative).\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n4. Received ≥2 prior lines of systemic therapy, including a platinum-based regimen (single-agent or combination); must have achieved partial response (PR) or stable disease (SD) during or after that platinum-based treatment.\n5. Platinum-sensitive disease defined as: Objective response (complete or partial) or stable disease lasting ≥6 months while on platinum-based therapy, or Platinum-free interval (PFI) ≥6 months from the end of the last platinum-containing regimen to documented progression\u002Frelapse.\n6. Estimated life expectancy ≥3 months.\n7. At least one measurable lesion per RECIST 1.1 on CT\u002FMRI; evidence of metastatic disease (soft-tissue and\u002For bone lesions) is required.\n8. Willing to provide archived tumour tissue (core biopsy or excision) or fresh biopsy\u002Fblood for biomarker analyses.\n9. Adequate organ function within 14 days (7 days for liver enzymes) before first dose:\n\n   Absolute neutrophil count ≥1.5 × 10⁹\u002FL Platelets ≥100 × 10⁹\u002FL Haemoglobin ≥80 g\u002FL Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT \\& AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Serum creatinine ≤1.25 × ULN and calculated creatinine clearance ≥60 mL\u002Fmin\n10. Toxicities from prior anti-cancer therapy resolved to Grade ≤1 per NCI-CTCAE v5.0 (except alopecia or other stable chronic toxicities deemed tolerable by the investigator).\n11. Participants of reproductive potential and their partners must agree to use highly effective contraception from 30 days before the first dose until 120 days after the last dose of fluzoparib.\n12. Signed written informed consent prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to fluzoparib or any of its excipients.\n2. Prior treatment with any PARP inhibitor.\n3. Use of strong CYP3A4 inhibitors within 14 days or strong CYP3A4 inducers within 28 days before first dose.\n4. Wash-out interval \\\u003C4 weeks from any prior anti-cancer therapy (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) to first dose.\n5. Planned anti-cancer therapy other than study drug during the trial period.\n6. Severe bone complications from bone metastases (uncontrolled pain, impending pathological fracture, or spinal cord compression within 6 months or judged likely to occur).\n7. Symptomatic or untreated brain metastases, leptomeningeal disease, spinal cord compression, or primary CNS tumors. (Stable brain metastases treated ≥28 days prior to first dose, without steroids and with confirmatory imaging showing no hemorrhage, may be allowed at investigator's discretion.)\n8. Active autoimmune disease requiring systemic therapy within the past 2 years.\n9. Recovery from major surgery under general anesthesia or severe trauma \\\u003C14 days before start of study treatment.\n10. Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU\u002FmL) or hepatitis C (anti-HCV positive and HCV RNA \\>ULN).\n11. Untreated CNS metastases.\n12. History of immunodeficiency (including HIV positive), congenital or acquired, or prior solid-organ transplant.\n13. Other malignancies within 5 years except adequately treated carcinoma in situ or indolent tumors judged by the investigator to have low risk of recurrence.\n14. Alcohol abuse (\\>14 units\u002Fweek) or drug abuse; inability to stop smoking (\\>10 cigarettes\u002Fday), nicotine products, grapefruit juice, or excessive caffeine\u002Ftea during the study.\n15. History of non-infectious pneumonitis requiring steroids or current pneumonitis.\n16. Clinically significant ECG abnormalities, including QTcF \\>470 ms in females (QTc calculated with Fredericia's formula).\n17. Conditions that could impair oral absorption: inability to swallow, active GI disease, bowel obstruction, inflammatory bowel disease, chronic diarrhea, short-bowel syndrome, or major upper-GI surgery (e.g., gastrectomy).\n18. Active infection or unexplained fever \\>38.5 °C on screening or day 1 (tumor fever allowed if investigator judges stable).\n19. Uncontrolled chronic systemic diseases (severe pulmonary, hepatic, renal, or cardiac).\n20. Thyroid function abnormalities (TSH, FT3, FT4) deemed clinically significant by the investigator.\n21. Bleeding diathesis: active peptic ulcer with positive fecal occult blood (FOB ++), melena or hematemesis within 2 months, or any condition predisposing to GI hemorrhage; gastric ulcer-type tumor without resection and judged at high risk of major bleeding; on thrombolytic\u002Fanticoagulant therapy that cannot be safely interrupted.\n22. Urinalysis ≥++ proteinuria confirmed by 24-h urine protein \\>1.0 g.\n23. Arterial or venous thrombo-embolic events (stroke, TIA, DVT, PE) within 6 months before screening.\n24. Active tuberculosis or acute infection requiring anti-infective therapy.\n25. Live-vaccine administration within 30 days before planned first dose.\n26. Additional exclusion: Any severe concomitant condition that, in the investigator's opinion, could compromise patient safety or interfere with study compliance (e.g., uncontrolled diabetes, thyroid disorders, psychiatric illness).","FEMALE",{"count":90,"type":23},72,[26],"Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1\u002F2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand breaks. PARP inhibitors (PARPi) exploit synthetic lethality to selectively eliminate BRCA-deficient tumor cells. Olaparib and talazoparib have demonstrated superior PFS and ORR versus chemotherapy in BRCA-mutated, HER2-negative advanced breast cancer, leading to FDA approval. In ovarian cancer, PARPi maintenance improves overall survival, with consistent benefits observed in Asian populations. The domestically developed PARPi fluzoparib, engineered with a trifluoromethyl moiety for enhanced stability and tissue penetration, showed in the phase III FABULOUS trial a median PFS of 6.7 vs 3.0 months and an ORR of 43.6% vs 23.3% compared with chemotherapy in gBRCA-mutated, HER2-negative breast cancer, with manageable safety. Data remain limited in Chinese patients and those with BRCA wild-type disease. This study aims to evaluate the efficacy and safety of fluzoparib maintenance monotherapy in advanced TNBC patients-either BRCA1\u002F2-mutated or wild-type-who have derived clinical benefit from prior platinum-based therapy.",[94,95,96],"Platinum-sensitive","TNBC, Triple Negative Breast Cancer","BRCA1\u002F2 Mutation or Not",[98,94,99],"TNBC","Maintenance Therapy","RECRUITING",{"date":33,"type":34},{"date":103,"type":34},"2026-01-20",{"date":105,"type":23},"2027-11-30",{"name":40,"class":41},{"id":108,"slug":109,"hasResults":12,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":88,"minAge":19,"maxAge":20,"enrollmentInfo":113,"targetDuration":4,"studyType":24,"phases":115,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},"100652553","phase-4-an-exploratory-study-on-the-efficacy-and-safety-of-enlonstobart-combined-with-concurrent-radiotherapy-and-chemotherapy-following-induction-therapy-with-enlonstobart-plus-chemotherapy-in-patients-with-locally-advanced-cervical-cancer-100652553","NCT07776821","An Exploratory Study on the Efficacy and Safety of Enlonstobart Combined With Concurrent Radiotherapy and Chemotherapy Following Induction Therapy With Enlonstobart Plus Chemotherapy in Patients With Locally Advanced Cervical Cancer.","Inclusion Criteria:\n\n* Ages 18-75;\n* Cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma confirmed by histology or cytopathology;\n* Patients with locally advanced cervical cancer who have not previously received any treatment and are classified as FIGO stage III-IV A as of 2018;\n* ECOG performance status 0-1;\n* Left ventricular ejection fraction (LVEF) ≥ 50%;\n* Bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FdL, platelets (PLT) ≥ 100 × 10⁹\u002FL;\n* Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 2.5 times the upper limit of normal (ULN); if liver metastases are present, ≤ 5×ULN; total bilirubin ≤ 1.5×ULN (this limit may be relaxed to 3×ULN for subjects with Gilbert's syndrome);\n* Renal function: Serum creatinine (Cr) ≤ 1.5×ULN; if \\> 1.5×ULN, creatinine clearance must be ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n* Coagulation: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) ≤ 1.5×ULN;\n* According to the RECIST 1.1 criteria, the patient must have at least one evaluable lesion;\n* Patients of childbearing potential must have a negative pregnancy test result and voluntarily use effective and reliable contraception during the study;\n* Voluntarily participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n* A history of active malignant tumors within 3 years prior to the first dose, excluding cervical cancer, which is the subject of this trial, and any locally curable tumors that have already undergone curative treatment (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, or cured carcinoma in situ, such as ductal carcinoma in situ of the breast);\n* Patients with active tuberculosis or a history of tuberculosis;\n* Patients with a history of interstitial lung disease or non-infectious pneumonia requiring glucocorticoid therapy;\n* Patients with hypertension that is not adequately controlled with antihypertensive medication (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 90 mmHg), or a history of hypertensive crisis or hypertensive encephalopathy;\n* Those who have experienced a serious cardiovascular event within 6 months prior to randomization, including but not limited to: stable angina classified as NYHA Class III-IV; unstable angina or myocardial infarction; NYHA Class III-IV congestive heart failure; severe arrhythmias requiring medication (asymptomatic atrial fibrillation is permitted if the ventricular rate can be controlled); Severe arterial or venous thromboembolic events (e.g., intracerebral hemorrhage, cerebral infarction, deep vein thrombosis, and pulmonary embolism);\n* Patients with active autoimmune diseases, or a history of autoimmune diseases within the 2 years prior to randomization, who still require systemic treatment. However, subjects with the following conditions may be considered for further screening: well-controlled type 1 diabetes; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases not requiring systemic treatment (such as vitiligo, psoriasis, or alopecia); or subjects whose condition is not expected to recur in the absence of external triggers.\n* Individuals with a known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS);\n* Subjects with uncontrolled pleural, pericardial, or abdominal\u002Fpelvic effusions requiring repeated drainage;\n* Subjects who have received immunosuppressive drugs or systemic corticosteroids for the purpose of immunosuppression (prednisone \\>10 mg\u002Fday or other equivalent medications) within 2 weeks prior to receiving the study drug;\n* Subjects who have undergone major surgery (craniotomy, thoracotomy, or laparotomy) within 28 days prior to the first administration of the study drug, or who still have unhealed wounds, ulcers, or fractures at the time of screening;\n* Subjects with a history of allogeneic hematopoietic stem cell transplantation or organ transplantation;\n* Subjects with other conditions deemed by the investigator to be incompatible with participation in this trial.",{"count":114,"type":23},31,[116],"PHASE4","The objective of this clinical trial is to investigate the efficacy and safety of Enlonstobart combined with concurrent chemoradiotherapy following induction chemotherapy for locally advanced cervical cancer. The primary questions it aims to address are:\n\nCan the Enlonstobart combination regimen improve the objective response rate and disease control rate in patients with locally advanced cervical cancer? What is the safety and tolerability profile of this combination regimen, and will any unexpected serious adverse events occur?\n\nParticipants will:\n\nReceive induction therapy with Enlonstobart in combination with chemotherapy agents (e.g., paclitaxel plus platinum); Receive Enlonstobart in combination with concurrent chemoradiotherapy (external beam radiation therapy plus brachytherapy, with concurrent chemotherapy); Undergo regular tumor imaging evaluations (CT\u002FMRI) and hematological safety assessments; Cooperate in completing efficacy assessments, adverse event documentation, and long-term follow-up.",[119],"Uterine Cervical Neoplasms",[121],"locally advanced carcinoma of the cervix","2026-08-18",{"date":57,"type":34},{"date":125,"type":34},"2025-09-01",{"date":127,"type":23},"2026-11-01",{"name":40,"class":41},2,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":137,"targetDuration":4,"studyType":24,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":42},"100650762","a-study-on-the-efficacy-of-different-doses-of-oryz-aspergillus-enzyme-and-pancreatin-tablet-in-treating-pancreatic-exocrine-insufficiency-after-gastrointestinal-surgery-100650762","NCT07751367","A Study on the Efficacy of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery","A Multicenter, Open-Label, Randomized Controlled Trial on the Efficacy and Safety of Different Doses of Oryz-Aspergillus Enzyme And Pancreatin Tablet in Treating Pancreatic Exocrine Insufficiency After Gastrointestinal Surgery","Inclusion Criteria:\n\n* Age between 18 and 75 years (inclusive of boundary values), regardless of gender;\n* History of prior gastrointestinal surgical treatment, including but not limited to:\n\nI. Post-pancreatectomy patients within 3-6 months (e.g., distal pancreatectomy, mid-pancreatectomy, total pancreatectomy, pancreatoduodenectomy); II. Post-gastrectomy patients within 2-6 months (e.g., partial gastrectomy excluding total gastrectomy);\n\n* For tumor patients, the primary tumor stage before or during surgery must be Stage I or II (AJCC 8th edition). Patients in the interval between anti-tumor treatments must have undergone a washout period exceeding 28 days to avoid interference from anti-tumor therapy on this study;\n* Diagnosis of pancreatic exocrine insufficiency (PEI) based on comprehensive assessment by the investigator considering medical history, symptoms, nutritional status, and pancreatic function;\n* Gastrointestinal Quality of Life Index (GIQLI) score ≤ 105 points;\n* Stable postoperative condition without systemic infection, anastomotic leak, or other severe postoperative complications;\n* Participants fully understand the study and voluntarily sign a written informed consent form approved by the ethics committee.\n\nExclusion Criteria:\n\n* Known allergy to any component of micafungin pancreatic enzyme tablets;\n* Patients with acute pancreatitis or acute exacerbation during active phase of chronic pancreatitis, or those with known contraindications listed in the product label;\n* Patients with rare inherited fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency\n* Gastrointestinal obstruction;\n* Use of other digestive enzyme replacement therapies during the study period;\n* Coexisting decompensated cirrhosis, active hepatitis with significant hepatic dysfunction, or other definite severe chronic diseases clearly affecting gastrointestinal motility and absorption (e.g., active inflammatory bowel disease); diabetes is not an exclusion criterion but must be documented in detail regarding type and treatment regimen;\n* Tumor patients who had distant metastasis (M1) preoperatively (AJCC 8th edition) or locally advanced unresectable tumors requiring non-curative surgery. Patients who received neoadjuvant chemotherapy\u002Fradiotherapy\u002Ftargeted therapy or other systemic anti-tumor treatments prior to or during surgery, even if the primary tumor was staged as Stage I or II;\n* Post-gastrointestinal surgery patients diagnosed clinically with gastroparesis, or meeting any of the following criteria for diagnosing delayed gastric emptying (DGE):\n\nI.Chronic refractory gastroparesis: duration \\> 6 months post-surgery, with persistent symptoms at moderate or greater severity despite standardized prokinetic therapy (e.g., metoclopramide, domperidone, erythromycin); II.Severe gastroparesis symptoms present at screening, which are the primary reason for patient visit; the researcher assesses symptom severity as equivalent to or worse than symptoms potentially caused by PEI (e.g., steatorrhea); III.Invasive interventions due to gastroparesis: such as placement of jejunal feeding tube, pyloric dilation, or surgical reconstruction, and still dependent on these measures for nutritional support;\n\n* Currently participating in another clinical trial, or recently completed another clinical trial without having reached the required washout period (within 28 days);\n* Other patients judged by the investigator as unsuitable for participation in this clinical trial.",{"count":138,"type":23},150,[140],"NA","This study aims to investigate the efficacy and safety of high-dose Oryz-Aspergillus Enzyme And Pancreatin Tablet in treating postoperative pancreatic exocrine insufficiency (PEI), aiming to fill the gap in evidence-based medicine and promote standardized treatment.",[143],"Pancreatic Exocrine Insufficiency, Adul","2026-08-06",{"date":146,"type":34},"2026-08-07",{"date":148,"type":23},"2026-09-18",{"date":150,"type":23},"2028-12-31",{"name":40,"class":41},{"id":153,"slug":154,"hasResults":12,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":160,"targetDuration":4,"studyType":24,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":42},"100629465","phase-3-a-study-of-neoadjuvant-tislelizumab-plus-lenvatinib-in-resectable-hcc-at-high-risk-of-recurrence-100629465","NCT07475026","A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence","Tislelizumab Plus Lenvatinib as Neoadjuvant Therapy for Patients With Resectable HCC at High Risk of Recurrence: a Prospective, Multicenter, Randomized Controlled Phase III Study","Neo-LENTIS","Inclusion Criteria:\n\n1. Voluntarily participates in this study and provides written informed consent.\n2. Aged 18 to 75 years, inclusive; male or female.\n3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.\n4. Child-Pugh class A liver function.\n5. China Liver Cancer (CNLC) stage Ib to IIa.\n6. Histologically\u002Fcytologically confirmed HCC, or clinically diagnosed primary hepatocellular carcinoma according to accepted diagnostic criteria, with lesions meeting the criteria for surgical resection as defined in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 edition).\n7. At least one measurable lesion per RECIST v1.1.\n8. Estimated life expectancy ≥ 6 months.\n9. Adequate major organ function as defined below, without transfusion of any blood components or use of hematopoietic growth factors within 14 days prior to assessment:\n\n   * Hematology\n\n     * Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³\n     * Platelet count ≥ 100,000\u002Fmm³\n     * Hemoglobin ≥ 5.6 mmol\u002FL (9 g\u002FdL)\n   * Hepatic and renal function\n\n     * Serum creatinine (SCr) ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula)\n     * Total bilirubin (TBIL) ≤ 1.5 × ULN\n     * AST and\u002For ALT ≤ 2.5 × ULN\n     * Urine protein \\\u003C 2+; if urine protein is ≥ 2+, 24-hour urine protein must be ≤ 1 g.\n10. Adequate coagulation function, with no active bleeding and no thrombotic disease:\n\n    * International normalized ratio (INR) ≤ 1.5 × ULN\n    * Activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN\n    * Prothrombin time (PT) ≤ 1.5 × ULN\n11. Contraception requirements:\n\n    * Women of childbearing potential must agree to use effective contraception (e.g., intrauterine device, oral contraceptives, or condoms) during study treatment and for 6 months after the last dose; must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be breastfeeding.\n    * Men with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the end of study treatment.\n12. Demonstrates good compliance and is able\u002Fwilling to complete required follow-up.\n\nExclusion Criteria:\n\n1. Prior antitumor therapy for the current HCC, including radiotherapy, chemotherapy, concurrent chemoradiotherapy, other locoregional therapies (e.g., TACE, HAIC), or prior immunotherapy or targeted therapy.\n\n   Note: Patients who developed recurrence after prior surgery may be enrolled; if prior postoperative adjuvant therapy was given, enrollment is allowed only if ≥6 months have elapsed since completion of adjuvant therapy.\n2. Known cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular-cholangiocarcinoma, or fibrolamellar carcinoma; or any other active malignancy besides HCC within the past 5 years or concurrently (except cured basal cell carcinoma of the skin and cervical carcinoma in situ).\n3. Hypertension inadequately controlled with antihypertensive therapy (systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg); or history of hypertensive crisis or hypertensive encephalopathy.\n4. Known hypersensitivity to macromolecular protein preparations, or known allergy to tislelizumab, lenvatinib, or any of their excipients.\n5. Any active autoimmune disease or history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis\u002Fcolitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Patients with vitiligo, or asthma that completely resolved in childhood and requires no intervention in adulthood, may be eligible. Patients with asthma requiring medical intervention with bronchodilators are not eligible.\n6. Use of immunosuppressive agents or systemic, or absorbable topical, corticosteroids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n7. Symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.\n8. Uncontrolled clinically significant cardiac symptoms or disease, including any of the following:\n\n   * New York Heart Association (NYHA) class \\> II heart failure\n   * Unstable angina\n   * Myocardial infarction within 1 year\n   * Clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention\n9. Within the past 3 months, presence of gastrointestinal conditions such as esophageal varices, active gastric or duodenal ulcer, ulcerative colitis, portal hypertension, or active bleeding from an unresected tumor; or any other condition judged by the investigator to confer a risk of gastrointestinal bleeding or perforation.\n10. History of or current severe bleeding (within 3 months, bleeding volume \\>30 mL), hemoptysis (within 4 weeks, \\>5 mL fresh blood), or thromboembolic events within 12 months (including stroke and\u002For transient ischemic attack).\n11. Active infection, or unexplained fever \\>38.5°C during screening or prior to first dose (fever judged by the investigator to be tumor-related is allowed).\n12. Objective evidence of prior or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired pulmonary function.\n13. Congenital or acquired immunodeficiency, such as HIV infection.\n14. Receipt of a live vaccine within 4 weeks prior to study drug administration, or anticipated need for live vaccination during the study.\n15. Known history of psychotropic drug abuse, alcoholism, or illicit drug use.\n16. Anticipated inability or unwillingness to comply with required study procedures, assessments, and follow-up (including completion of standard-of-care evaluations not covered by the study), as judged by the investigator.\n17. Any other condition that, in the investigator's judgment, makes the subject unsuitable for the study, including factors that may lead to premature study discontinuation (e.g., other serious diseases \\[including psychiatric disorders\\] requiring concomitant treatment, severe laboratory abnormalities, or family\u002Fsocial factors that may compromise subject safety or the collection of data and specimens).",{"count":161,"type":23},198,[163],"PHASE3","This is a prospective, multicenter, randomized controlled, phase 3 study to explore the efficacy and safety of neoadjuvant tislelizumab plus lenvatinib in patients with resectable HCC at high risk of recurrence.",[166],"HCC - Hepatocellular Carcinoma","2026-08-03",{"date":169,"type":34},"2026-08-05",{"date":171,"type":34},"2026-06-09",{"date":173,"type":23},"2030-12-31",{"name":40,"class":41},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":24,"phases":184,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":194,"locationsCount":42},"100559923","phase-2-glofitamab-combination-with-chidamide-in-patients-with-recurrentrefractory-dlbcl-100559923","NCT06570447","Glofitamab Combination With Chidamide in Patients With Recurrent\u002FRefractory DLBCL","An Open-label, Single-arm, Single-center, Phase II Clinical Trial of Glofitamab Combination With Chidamide in Patients With Recurrent and Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n\\- To be eligible for enrollment in this study, a subject must meet all of the following criteria:\n\n1. Signed informed consent\n2. Age ≥ 18 years at the time of informed consent\n3. Patients must be willing and able to comply with protocol-specified hospitalization requirements following administration of Glofitamab. Patients must also be willing to comply with all study-related procedures.\n4. Histologically confirmed DLBCL, including any of the following 2016 WHO Lymphocytes Neoplasm classifications (Swerdlow et al. 2016) Diagnosis: DLBCL-NOS, HGBCL, PMBCL and FL transformed DLBCL (trFL)\n\n   \\- A pathology report (if available) from the initial histopathological diagnosis must be provided. Patients with trFL must also provide a pathology report (if available) at the time of disease transformation. Results of all tissue tests performed at initial diagnosis should be provided, including but not limited to tests to assess cellular origin, BCL2, and MYC abnormalities (if performed).\n5. Patients must have relapsed or Cap following at least two prior lines of systemic therapy (including at least one prior regimen containing anthracene Treatment failure and at least one prior regimen containing anti-CD20 targeted therapy).\n\n   * Patients may have received Autologous haematopoietic stem cell transplant (HSCT) prior to recruitment; consolidative autologous HSCT after Chemotherapy will be counted as a line of therapy.\n   * CAR T cells plus bridging were counted as a treatment line.\n   * Local therapies (e.g., radiotherapy) will not be considered as treatment lines.\n6. Patients must have measurable disease: at least one bidimensionally measurable Lymphadenopathy, defined as \\> 1.5 cm in the longest diameter; or at least one bidimensionally measurable extranodal lesion, defined as \\> 1.0 cm in the longest diameter.\n7. Verify availability of Neoplasm tissues, unless not available per investigator assessment. Freshly collected Biopsy specimens are preferred. Representative Neoplasm tissue specimens or unstained serial sections are acceptable.\n8. Eastern Cooperative Neoplasm Group (ECOG) performance status of 0 or 1\n9. Life expectancy (as assessed by the investigator) ≥ 12 weeks\n10. Carcinoma due to prior anti Adverse event therapy must have resolved to ≤ grade 1 (except Alopecia and Hyporexia).\n11. Adequate liver function\n\n    * Bilirubin total ≤ 1.5 x upper limit of normal (ULN); patients with documented history of Gilbert's syndrome: Bilirubin total ≤ 3 x ULN with elevated indirect Bilirubin;\n    * AST\u002FALT ≤ 3 × ULN\n12. Adequate hematological function:\n\n    * Neutrophil count ≥ 1.5 x 109 cells\u002FL (1.500\u002FμL);\n    * Platelet count ≥ 75,000\u002FμL (and no Platelet transfusion within 14 days before Gpt administration on Day 1 of Cycle 1);\n    * Haemoglobin ≥ 10.0 g\u002FdL (6.2 mmol\u002FL); no Transfusion within 21 days prior to Gpt dosing on Cycle 1 Day 1\n13. Adequate renal function: Serum creatinine ≤ 1.5 × ULN or Creatinine clearance ≥ 50 mL\u002Fmin calculated according to the C OC kroft Gault formula (see Appendix 14) (patients whose renal function is not adequately reflected by Serum creatinine levels as judged by the investigator)\n14. Negative serum Pregnancy test within 7 days prior to study treatment for women of childbearing potential. Amenorrhoea is not required for women of non-childbearing potential who are post-menopausal (≥ 12 months of non-therapeutic Surgery) or Pregnancy test sterilized (absence of ovaries and\u002For uterus). For women of childbearing potential: Agree to remain abstinent (avoid heterosexual intercourse) or to take Contraception measures.\n15. For men: Agree to remain abstinent (avoid heterosexual intercourse) or practice Contraception\n\nExclusion Criteria:\n\nAny subject who meets any of the following criteria should not be enrolled in the study:\n\n1. Inability to comply with protocol-specified hospitalization and restrictions\n2. Richter's transformation\n3. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other Infection (excluding Nail bed infection fungal) at study entry or any major Infection (as evaluated by the investigators) within 4 weeks prior to first study treatment Contacts and Locations\n4. Suspected or Latent tuberculosis disease (confirmed by positive IFNγ release assay)\n5. Positive test result for Chronic hepatitis B virus (HBV) Infection (defined as positive Hepatitis B surface antigen \\[HBsAg\\] serology).\n\n   \\- Patients with occult or previous HBV Infection (defined as HBsAg negative and Hepatitis B core antibody \\[HBcAb\\] positive) may be included if HBV DNA is undetectable, provided they are willing to undergo HBV DNA testing monthly during study treatment (or on Day 1 of each cycle) and monthly for at least 12 months after the last cycle, and are willing to receive appropriate antiviral therapy.\n6. Positive Hepatitis C virus (HCV) Antibody test\n\n   \\- Patients with HCV Polymerase chain reaction are eligible only if the PCR (Antibody positive) is negative for HCV RNA.\n7. Known HIV seropositive status\n\n   \\- For patients with unknown HIV status, HIV testing will be performed at screening if required by local regulations.\n8. Known or suspected chronic active Epstein-Barr Viral infection\n9. Known or suspected history of Haemophagocytic lymphohistiocytosis (H LH)\n10. Pregnancy or lactating, or planning to Pregnancy during treatment and for at least 3 months after the last dose of Gpt or within 2 months after the last dose of Glofitamab\n11. A history of treatment-emergent Immunization related Immunization associated with prior Adverse event treatment agents as follows:\n\n    * Grade 3 Adverse event, except for Grade 3 endocrinopathy managed with alternative therapy\n    * Grade 1-2 Adverse event that did not return to baseline after Therapy cessation\n12. Documented refractory to Obinutuzumab monotherapy\n13. Active autoimmune disease requiring treatment requires investigator assessment of Immunization\n14. Evidence of significant, uncontrolled concomitant disease that could affect adherence to the study protocol or interpretation of results, including Immunization, relevant Lung disorder history (Bronchospasm, Obstruction Pneumopathy), and known autoimmune Diabetes mellitus\n15. History of severe Allergy or Allergic reaction to monoclonal antibody therapy (or recombinant antibody-associated fusion Protein)\n16. History of confirmed progressive multifocal Leukoencephalopathy (PML)\n17. Current or past history of CNS Lymphoma\n18. Current or past history of CNS disease such as Stroke, Epilepsy, CNS Vasculitis, or neurodegenerative disease\n19. Another invasive Neoplasm malignant within the last 2 years (except Basal cell carcinoma and Neoplasm with a low likelihood of recurrence)\n20. Serious or extensive Angina unstable such as New York Heart disorder Association Class III or IV or objectively assessed Class C or D Cardiac disorder, Myocardial infarction within the last 6 months, unstable Arrhythmia, or Cardiovascular disorder\n21. Administration of a live attenuated vaccine within 4 weeks prior to Gpt infusion, or anticipated need for a live attenuated vaccine during the study. ( Note: Flu vaccination should only be administered during the Flu season. Patients must not receive live attenuated Flu vaccine at any time during study treatment.)\n22. Systemic Tumour necrosis agents (including but not limited to Cap Phosphorus amide, thiazolyl Purines, methotrexate, thalidomide, and anti Ammonia factor agents) within 2 weeks prior to Gpt infusions\n\n    * Corticosteroid therapy with ≤ 25 mg\u002Fday prednisone or equivalent is allowed.\n    * Inhaled and topical steroids are allowed.\n23. History of illicit drugs or Alcohol abuse within 12 months prior to screening, as judged by the investigators.\n24. Any other disease, metabolic dysfunction, Physical examination result, or clinical lab result reasonably suspecting a disease or condition that contraindicates the use of an investigational drug\n25. Investigators should review the Vaccination status of potential study patients considered for this study and follow local disease control and prevention guidelines for vaccination of any other non-live vaccinated adults aiming to prevent infectious diseases prior to the study.\n26. Any mental or Cognitive disorder that would limit the understanding, conduct, and compliance with the informed consent form;\n27. Pregnancy or lactating females, or females or male partners planning to Pregnancy during the study;\n28. Other situations that the investigators consider Discomfort to be eligible for this trial",{"count":183,"type":23},22,[26],"An open-label, single-arm, single-center, phase II clinical trial to evaluate the feasibility, efficacy and safety of Glofitamab Combination with chidamide in patients with recurrent\u002Frefractory diffuse large B-cell lymphoma.",[187,188],"Diffuse Large B-Cell Lymphoma-Recurrent","Diffuse Large B-Cell Lymphoma-Refractory","2026-07-31",{"date":167,"type":34},{"date":192,"type":34},"2025-02-27",{"date":150,"type":23},{"name":40,"class":41},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":24,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":129},"100649608","a-single-arm-multi-center-phase-ii-exploratory-clinical-study-to-evaluate-the-efficacy-and-safety-of-trilaciclib-in-preventing-myelosuppression-caused-by-topoisomerase-i-inhibitor-type-adc-drugs-100649608","NCT07736001","A Single-arm, Multi-center, Phase II Exploratory Clinical Study to Evaluate the Efficacy and Safety of Trilaciclib in Preventing Myelosuppression Caused by Topoisomerase I Inhibitor Type ADC Drugs","Trilaciclib","Inclusion Criteria:\n\n1. The patient voluntarily participated in this study, signed the informed consent form, had good compliance and cooperated with the follow-up;\n2. Age greater than 18 years old, regardless of gender;\n3. Malignant tumors diagnosed by histological or cytological examination;\n4. Cancer patients whose tumors can be treated with topoisomerase I inhibitor type ADC drugs (Regucitinib, Gosatuzumab, Luconasuzumab, Deconzumab) as evaluated by the investigator;\n5. Patients are allowed to have received systemic anti-tumor treatment in the past;\n6. ECOG physical status score 0-2;\n7. No gastrointestinal obstruction, such as gastric pyloric stenosis or intestinal obstruction;\n8. Expected survival period ≥ 12 weeks;\n9. Good organ and bone marrow function, defined as follows: Hematological system: Absolute neutrophil count (ANC) ≥ 1.5×109\u002FL; Platelets (PLT) ≥ 90×109\u002FL; Hemoglobin: ≥ 90 g\u002FL; Liver function: Total bilirubin (TBIL) ≤ 1.5×ULN (for patients with Gilbert syndrome, ≤ 3×ULN); Aspartate aminotransferase ≤ 2.5×ULN (for patients with liver metastasis ≤ 5×ULN); Alanine aminotransferase ≤ 2.5×ULN (for patients with liver metastasis: ≤ 5×ULN); Albumin ≥ 30 g\u002FL; Renal function: Creatinine ≤ 1.5×ULN; Creatinine clearance rate (only when creatinine \\> 1.5×ULN is calculated): Endogenous creatinine clearance rate ≥ 50 mL\u002Fmin (Cockcroft-Gault formula); Cardiac function: 12-lead electrocardiogram: No severe arrhythmia, and the mean corrected QT interval (QTc) by Fridericia method (for males) is \\\u003C 450 ms, QTc \\\u003C 470 ms (for females); Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%;\n10. Within 2 weeks before enrollment, no use of granulocyte colony-stimulating factor (g-csf), erythropoiesis-stimulating agents (ESAs), or bone marrow suppression prevention or correction-related drugs or treatments such as red blood cell (RBC) and\u002For platelet transfusion;\n11. Exclude patients who have previously experienced infection or interstitial pneumonia; twelve For the fertile subjects, the serum pregnancy test was negative within 72 hours before the first use of the study drug, and they agreed to use effective contraceptive measures from the time of signing the informed consent form until 180 days after the last use of the investigational drug.\n\nExclusion Criteria:\n\n* 1\\. No history of myeloid leukemia, myelodysplastic syndrome or concurrent sickle cell disease; 2. Within one week before the blood test during the screening period, received hematopoietic growth factors, blood transfusion or platelet transfusion treatment; 3. Have any active autoimmune diseases or have a history of autoimmune diseases; 4. Within two weeks before the first administration, received systemic corticosteroids (daily \\> 10mg prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, TNF-α inhibitors, etc.) on a daily basis; 5. Within 4 weeks before enrollment, had a severe infection requiring intravenous antibiotics treatment or active infection; 6. Severe cardiovascular injury (greater than NYHA II grade congestive heart failure history), unstable angina pectoris or myocardial infarction within the past 6 months, or severe arrhythmia. At screening, QTcF interval \\> 480 msec, for patients with implanted ventricular pacemaker, QTcF \\> 500 msec; 7. Within 6 months before enrollment, had a stroke or cerebrovascular event; 8. Subjects with a recipient of allogeneic organ transplantation requiring immunosuppressive therapy; 9. Known human immunodeficiency virus (HIV) positive subjects; 10. Uncontrolled active hepatitis B (defined as a positive result for hepatitis B surface antigen HBsAG during the screening period, while the HBV DNA test value is higher than the upper limit of the laboratory department's normal value in the research center; subjects who tested HBV DNA content \\\u003C 500 IU\u002FmL within 28 days before randomization and have received at least 4 weeks of local standard antiviral treatment and are willing to continue antiviral treatment during the study can be enrolled); active hepatitis C (defined as a positive result for hepatitis C surface antibody HCsAb during the screening period and positive HCV RNA) subjects; 11. Previously had concurrent other malignant tumors for ≤ 5 years, fully treated cervical carcinoma in situ, basal cell or squamous epithelial cell skin cancer, locally advanced prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery. Patients who are not excluded if they have been fully treated; 12. Expected to need any other form of anti-tumor treatment during the study period; 13. Active brain metastasis; 14. Received traditional Chinese medicine or immunomodulatory drugs with anti-tumor indications within 2 weeks before the first administration; 15. Received live vaccines within 30 days before the first administration of the study treatment; 16. Any medical condition as determined by the investigator that makes the subject unsuitable for enrollment in the study.",{"count":203,"type":23},96,[140],"Evaluation of the efficacy and safety of Trilaciclib in preventing myelosuppression caused by topoisomerase I inhibitor type ADC drugs",[207],"Tumor Patients","2026-07-29",{"date":210,"type":34},"2026-07-30",{"date":212,"type":23},"2026-07",{"date":214,"type":23},"2029-07",{"name":40,"class":41},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":223,"maxAge":4,"enrollmentInfo":224,"targetDuration":4,"studyType":24,"phases":226,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":42},"100623530","phase-2-crp-regimen-in-treating-elderly-patients-with-previously-untreated-double-positive-dlbcl-100623530","NCT07397832","CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL","CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial","Inclusion Criteria:\n\n1. Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.\n2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).\n3. Histopathological confirmation meeting all of the following conditions:\n\n   1. Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).\n   2. At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.\n4. Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):\n\n   1. Hematology: Hb ≥90 g\u002FL, ANC ≥1.5 × 10⁹\u002FL, PLT ≥90 × 10⁹\u002FL.\n   2. Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).\n5. Life expectancy of at least 6 months, as judged by the investigator.\n6. Ability to understand and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. History of or concurrent other active malignancies.\n2. Prior treatment with Chidamide and\u002For R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity\u002Fallergy to murine products.\n3. Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.\n4. History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty\u002Fstenting within 12 months.\n5. Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.\n6. Pregnant or lactating women.\n7. Participation in any other clinical trial within 6 months prior to signing informed consent.\n8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.","60 Years",{"count":225,"type":23},58,[26],"A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma",[229],"Diffuse Large B-Cell Lymphoma (DLBCL)",[231],"Diffuse Large B-Cell Lymphoma","2026-07-28",{"date":208,"type":34},{"date":235,"type":34},"2026-02-03",{"date":237,"type":23},"2028-12-30",{"name":40,"class":41},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":247,"targetDuration":4,"studyType":24,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":259,"completionDateStruct":260,"leadSponsor":262,"locationsCount":4},"100649542","study-on-the-combined-treatment-of-hepatocellular-carcinoma-with-envafolimab-suvemcitug-and-haic-conversion-100649542","NCT07738055","Study on the Combined Treatment of Hepatocellular Carcinoma With Envafolimab, Suvemcitug and HAIC Conversion","An Exploratory Study on the Use of Envafolimab Combined With Suvemcitug and HAIC for the Conversion Therapy of Potentially Resectable Hepatocellular Carcinoma","HCC","Inclusion Criteria:\n\n1. Sign a written informed consent form before enrollment;\n2. Age 18-75 years old;\n3. Diagnosed with hepatocellular carcinoma (HCC) by clinical assessment;\n4. Patients with stage IV or III unresectable liver cancer;\n5. Have measurable lesions (according to the RECIST 1.1 standard, non-lymph node lesions with CT scan diameter ≥ 10 mm, lymph node lesions with CT scan diameter ≥ 15 mm);\n6. Have not received any systemic anti-tumor treatment before, including but not limited to immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine treatment;\n7. Child-Pugh score ≤ 7 points;\n8. Have sufficient organ function; 1) Blood routine: White blood cell (WBC) ≥ 3.5 × 10\\^9\u002FL, absolute neutrophil count (ANC) 1.5 × 10\\^9\u002FL, platelet (PLT) ≥ 100 × 10\\^9\u002FL, hemoglobin (HGB) ≥ 90 g\u002FL; 2) Liver function: Serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; 3) Kidney function: Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 mL\u002Fmin (using the standard Cockcroft-Gault formula); 4) Coagulation function: International normalized ratio (INR) ≤ 1.5 \u002F PT ≤ 1.5 × ULN, aPTT ≤ 1.5 × ULN; if the subject is receiving anticoagulation treatment, as long as PT and INR are within the range prescribed by the anticoagulant drug, it is acceptable.\n\n10\\. Estimated survival period ≥ 3 months; 11. Pregnant women should agree to use contraceptive measures (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 6 months after the study; the serum HCG test should be negative within 7 days before enrollment, and must be non-lactating patients; men should agree to use contraceptive measures during the study period and within 6 months after the study.\n\nExclusion Criteria:\n\n1. Those who refuse to sign the informed consent form or refuse to undergo follow-up;\n2. Subjects who have previously or concurrently suffered from other malignant tumors;\n3. Patients who have received systemic anti-tumor treatment in the past;\n4. Those who are currently candidates for liver transplantation or have undergone liver transplantation;\n5. Those with a risk of bleeding, or coagulation dysfunction, or are undergoing thrombolytic therapy; or have experienced esophageal or gastric variceal bleeding within the past 6 months;\n6. Subjects who are known to have previously been allergic to large molecule protein preparations or the components of the applied drugs;\n7. Subjects with any active autoimmune diseases or a history of autoimmune diseases (as listed below, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitaryitis, vasculitis, nephritis, thyroid dysfunction (hyperthyroidism\u002Fhypothyroidism), and the use of drugs that cannot maintain thyroid function within the normal range, or previous thyroid surgery, and long-term thyroid hormone replacement therapy is required after the surgery; subjects with vitiligo or who had completely resolved asthma in childhood and do not require any intervention in adulthood can be included; subjects with asthma who require bronchodilators for medical intervention cannot be included);\n8. Subjects who are currently using immunosuppressants, or systemic, or absorbable local hormone treatments to achieve immunosuppression purposes (dose \\> 10mg\u002Fday prednisone or other drugs with equivalent efficacy), and are still using them within 2 weeks before enrollment;\n9. Subjects who are using traditional Chinese medicine or other immunomodulatory agents within 2 weeks before enrollment;\n10. Have poorly controlled clinical symptoms or diseases of the heart, such as: (1) NYHA grade 2 or above heart failure (2) unstable angina pectoris (3) having had a myocardial infarction within 1 year (4) having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention;\n11. Subjects with congenital or acquired immune deficiencies, such as HIV-infected individuals, or active hepatitis (transaminase does not meet the inclusion criteria, for hepatitis B: HBV DNA ≥ 2000 IU\u002Fml or ≥ 104 copies\u002Fml; for hepatitis C: HCV RNA ≥ 2000 IU\u002Fml or ≥ 104 copies\u002Fml; after nucleotide antiviral treatment, below the above standards can be included); chronic hepatitis B virus carriers, HBV DNA \\\u003C 104 IU\u002Fml, can be enrolled during the trial period if they must receive antiviral treatment simultaneously;\n12. Less than 4 weeks before the study medication, or may have received live vaccines during the study period;\n13. Subjects with known history of substance abuse of psychotropic drugs, alcoholism or drug abuse;\n14. The investigator considers it necessary to exclude from this study, for example, if the subject is judged by the investigator to have other factors that may cause the study to be prematurely terminated, such as, other serious diseases (including mental disorders) that require combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the safety of the subject, or the collection of data and samples.",{"count":248,"type":23},35,[140],"This study is a single-center, exploratory clinical trial. Eligible patients with liver cancer, after signing the informed consent form, will be screened and enrolled. They will receive a 3-cycle conversion treatment with Envafolimab combined with Suvemcitug and HAIC. During the treatment process, clinical tumor imaging assessment will be conducted using RECIST V1.1. Imaging evaluations will be performed before treatment and at the end of the 3rd cycle of treatment (±3 days). Subsequently, an MDT assessment will be conducted to determine if the surgical resection criteria are met. If the criteria are met, a radical surgery will be performed based on the subject's wishes and postoperative treatment will be provided. If the criteria are not met, the study will be decided to continue with the original treatment plan or another treatment plan. CTCAE 5.0 will be used for safety assessment. Adverse events will be recorded throughout the study period until 30 days after the end of treatment (for severe adverse events or adverse events related to Envovalimab, the recording period will be extended to 90 days after the end of treatment). To ensure study safety, 3 patients will be enrolled as a safety introduction cohort first, and a 3-cycle conversion treatment with Suvemcitug combined with Envafolimab and HAIC will be used. If a DLT occurs, 3 more patients will be enrolled. If the overall DLT does not exceed 1\u002F3, the original treatment plan will be maintained for the study. If the overall DLT is greater than 1\u002F3, the drug related to the DLT will be re-evaluated and the dose will be adjusted.",[252],"Potentially Resectable Hepatocellular Carcinoma",[254,255,256],"Potentially resectable hepatocellular carcinoma","Envafolimab","Suvemcitug","2026-07-27",{"date":210,"type":34},{"date":189,"type":23},{"date":261,"type":23},"2029-07-31",{"name":40,"class":41},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":269,"targetDuration":4,"studyType":24,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":278,"locationsCount":42},"100649497","to-explore-a-single-arm-phase-ii-study-on-intestinal-microbiota-transplantation-combined-with-neoadjuvant-immunotherapy-and-chemoradiotherapy-for-locally-advanced-rectal-cancer-under-msspmmr-100649497","NCT07738042","To Explore a Single-arm Phase II Study on Intestinal Microbiota Transplantation Combined With Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Rectal Cancer Under MSS\u002FpMMR","Inclusion Criteria:\n\n1. ECOG PS 0-1\n2. The lower edge of the tumor is ≤12cm from the anal margin. After multidisciplinary assessment, R0 resection is possible\n3. RAS\u002FBRAF wild type, pMMR\u002FMSS status\n4. Patients of childbearing age need to take effective contraceptive measures.\n5. Voluntarily sign the informed consent form\n\nExclusion Criteria:\n\n1. dMMR\u002FMSI-H type\n2. Has previously received anti-tumor treatment (including surgery, radiotherapy, chemotherapy, targeted therapy or immunotherapy);\n3. Active autoimmune diseases, inflammatory bowel disease;\n4. Active infection, immune deficiency, severe liver and kidney dysfunction;\n5. Severe intestinal obstruction, perforation or requiring emergency surgery;\n6. Pregnant or lactating women;\n7. Contraindications related to FMT (such as recent use of high-dose immunosuppressants, severe neutropenia, etc.);\n8. Other circumstances where participation in clinical trials is not suitable",{"count":270,"type":23},46,[140],"To evaluate the pathological complete response rate (pCR) of intestinal flora transplantation combined with short-course radiotherapy +CAPOX+ sintilimab in neoadjuvant therapy for locally advanced rectal cancer (pMMR\u002FMSS type)",[274],"Locally Advanced Rectal Cancer (LARC)",{"date":210,"type":34},{"date":189,"type":23},{"date":173,"type":23},{"name":40,"class":41},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":286,"targetDuration":4,"studyType":24,"phases":288,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":298,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"100649343","phase-2-comparing-ici-followed-by-ccrt-and-ccrt-followed-by-immunotherapy-in-unresectable-la-escc-100649343","NCT07733830","Comparing ICI Followed By CCRT And CCRT Followed By Immunotherapy In Unresectable LA-ESCC","Comparing Induced Chemoimmunotherapy Followed By Concurrent Chemoradiotherapy And Concurrent Chemoradiotherapy Followed By Immunotherapy In Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Randomized, Phase II Trial","Inclusion Criteria:\n\n1. Volunteered to participate, cooperated with follow-up visits, documented informed consent;\n2. Aged 18 -75 years, both male and female;\n3. Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC); clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery);\n4. Measurable and\u002For unmeasurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST1.1) and the Japanese Classification of Esophageal Cancer (12th Edition: Part II);\n5. Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);\n6. ECOG performance status 0 or 1;\n7. Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded \\[FFPE\\] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;\n8. Expected survival ≥ 3 months;\n9. Adequate hematologic function, defined as ANC ≥1500\u002Fμl, platelet count ≥100,000\u002Fμl and hemoglobin count ≥9.0 g\u002Fdl or ≥5.6 mmol\u002Fl; Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL\u002Fmin for those with creatinine levels \\>1.5× ULN (Calculated from the Cockcroft-Gault formula); Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT\u002FAST\u002FAKP levels ≤2.5× ULN and albumin ≥2.8 g\u002Fdl; Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;\n10. Women of childbearing potential with a negative urine pregnancy test within 3 days before the first administration of the investigational drugs.\n\nExclusion Criteria:\n\n1. Surgery for esophageal cancer;\n2. Esophageal fistulae due to infiltration of the primary tumour;\n3. Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation\n4. Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;\n5. Major surgery or severe trauma within 4 weeks prior to first use of study drug;\n6. Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;\n7. Received or receiving any of the following treatments in the past:\n\n   1. Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;\n   2. Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;\n   3. Systemic treatment with corticosteroids (\\>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the oesophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor.Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses \\>10mg\u002Fday prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;\n   4. Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;\n8. Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;\n9. Diagnosis of immunodeficiency, including positive HIV test,other acquired\u002Fcongenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;\n10. Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n11. Severe infections (CTCAE \\> Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;\n12. History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;\n13. Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;\n14. Presence of active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);\n15. Presence of abnormal sodium, potassium, and calcium laboratory test values greater than Grade 1 within 2 weeks prior to randomisation that do not improve with treatment;\n16. Known hypersensitivity to large protein preparations, or to any of the components of nab-paclitaxel or carboplatin or to any of the components used within their preparations;\n17. Any other malignant tumor was diagnosed before the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate \\> 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;\n18. Pregnant or lactating patients;\n19. After the researchers' judgment, the subjects have other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, having other serious diseases recently (such as myocardial infarction, cerebrovascular accident) that are considered to have a high risk of recurrence, severely abnormal laboratory test values, family or social factors. Situations that may affect the safety of the subjects or the collection of experimental data.",{"count":287,"type":23},120,[26],"A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups.\n\nArm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy\u002F1.8Gy\u002F28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles.\n\nArm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy\u002F1.8Gy\u002F28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles.\n\nThis study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.",[291],"Esophageal Cancer",[293,294,295],"Induction Immunochemotherapy","Adebrelimab","Esophageal Squamous Cell Carcinoma","2026-07-26",{"date":208,"type":34},{"date":189,"type":23},{"date":300,"type":23},"2029-12-31",{"name":40,"class":41},7,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":42},"100649030","phase-2-a-phase-ii-exploratory-study-of-sacituzumab-tirumotecan-combined-with-envafolimab-for-trop2-positive-advanced-biliary-tract-cancers-previously-treated-with-first-line-immunotherapy-combined-with-chemotherapy-100649030","NCT07729033","A Phase II Exploratory Study of Sacituzumab Tirumotecan Combined With Envafolimab for TROP2-Positive Advanced Biliary Tract Cancers Previously Treated With First-Line Immunotherapy Combined With Chemotherapy.","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 75 years at the time of signing the informed consent form, regardless of gender;\n* Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer);\n* Have received first-line PD-1\u002FPD-L1 inhibitor combined with chemotherapy and have experienced disease progression during or after systemic therapy;\n* TROP2 immunohistochemistry score of 2+ or 3+;\n* At least one measurable lesion per RECIST v1.1;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to dosing;\n* Life expectancy ≥ 12 weeks;\n* Adequate organ and bone marrow function (without blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to dosing), defined as follows:\n\n  1. Hematology: absolute neutrophil count (NEUT#) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 100 × 10⁹\u002FL; hemoglobin ≥ 90 g\u002FL;\n  2. Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; for subjects with baseline liver metastases, ALT and AST ≤ 5 × ULN; albumin ≥ 30 g\u002FL; total bilirubin (TBIL) ≤ 1.5 × ULN;\n  3. Renal function: creatinine clearance ≥ 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula);\n  4. Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤ 1.5 × ULN;\n* Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to use effective medical contraceptive measures from the signing of the informed consent form through 6 months after the last dose ;\n* Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with protocol-specified visits and related procedures.\n\nExclusion Criteria:\n\n* Prior receipt of any of the following treatments (including in the adjuvant\u002Fneoadjuvant setting):\n\n  1. TROP2-targeted therapy;\n  2. Any drug targeting topoisomerase I, including antibody-drug conjugate (ADC) therapy;\n* Use of strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) within 2 weeks prior to the first dose or during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study; representative drugs are listed in Appendix 7); all subjects must avoid concomitant use of any known CYP3A4-inducing drugs, herbal supplements, and\u002For consumption of such foods;\n* Documented history of severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or corneal disease that impairs\u002Fdelays corneal healing;\n* History of or current central nervous system (CNS) metastases;\n* Other malignancy within 3 years prior to dosing (except for tumors cured by local therapy, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, etc.);\n* Presence of any of the following cardiovascular or cerebrovascular diseases or risk factors:\n\n  1. Myocardial infarction, unstable angina, acute or persistent myocardial ischemia, Grade 3 or 4 heart failure (per New York Heart Association \\[NYHA\\] classification), symptomatic or poorly controlled severe arrhythmias, cerebrovascular accident, transient ischemic attack, or other serious cardiovascular or cerebrovascular diseases within 6 months prior to dosing;\n  2. History of myocarditis, primary cardiomyopathy, specific cardiomyopathy, or other myocardial diseases;\n  3. Any deep vein thrombosis (subjects may be enrolled if stable on low-molecular-weight heparin or similar therapeutic agents for ≥ 2 weeks), peripheral arterial thromboembolic events, pulmonary embolism, or other serious thromboembolic events within 3 months prior to dosing;\n  4. Aortic aneurysm, aortic dissecting aneurysm, or other major vascular diseases that may be life-threatening or require surgery within 6 months prior to dosing;\n* Uncontrolled systemic diseases per investigator judgment:\n\n  1. Poorly controlled diabetes (fasting blood glucose ≥ 10 mmol\u002FL on two consecutive occasions);\n  2. Poorly controlled hypertension (systolic blood pressure \\> 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg);\n  3. Clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (\\> 1 time\u002Fweek);\n* History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening;\n* Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, intra-abdominal abscess, or acute gastrointestinal bleeding;\n* Toxicity from prior anti-tumor therapy has not recovered to ≤ Grade 1 (per NCI CTCAE v5.0) or to the levels specified in the eligibility criteria (excluding toxicities deemed by the investigator to have low safety risk, such as alopecia and fatigue);\n* Active autoimmune disease requiring systemic treatment within the past 2 years, including disease-modifying antirheumatic drugs, immunosuppressants, or systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent). Hormone replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy; subjects receiving systemic corticosteroids \\> 10 mg\u002Fday prednisone or other immunosuppressive agents within 2 weeks prior to dosing;\n* Known active pulmonary tuberculosis. Subjects with suspected active pulmonary tuberculosis must undergo clinical examination to rule it out;\n* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n* Active hepatitis B \\[hepatitis B surface antigen (HBsAg)-positive, with HBV-DNA ≥ 500 IU\u002FmL or above the lower limit of detection, whichever is higher\\] or active hepatitis C (hepatitis C antibody-positive with HCV-RNA above the lower limit of detection). Note: HBsAg-positive subjects are required to receive anti-HBV therapy during the study treatment period;\n* Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection;\n* Known allergy to the study drug or any of its components, or history of severe hypersensitivity reactions to other biological agents;\n* Major surgery within 4 weeks prior to dosing, or expected to require major surgery during the study period;\n* Severe infection within 4 weeks prior to dosing, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to dosing;\n* Receipt of non-specific immunomodulatory therapy (including but not limited to interferon, IL-2) or proprietary Chinese medicine preparations approved for anti-tumor indications within 2 weeks prior to dosing;\n* Vaccination with live vaccine within 30 days prior to dosing, or planned vaccination with live vaccine during the study period;\n* Rapid deterioration of disease during the screening period prior to dosing, such as significant changes in performance status;\n* Pregnant or breastfeeding women;\n* Local or systemic diseases unrelated to malignancy, or diseases or symptoms secondary to tumor, that may confer high medical risk and\u002For uncertainty in survival assessment, such as leukemoid reaction, cachexia, etc.;\n* Any condition that, in the investigator's opinion, would interfere with the evaluation of the study drug, subject safety, or interpretation of study results, or any other condition deemed by the investigator as inappropriate for participation in this study.",{"count":310,"type":23},28,[26],"This is a prospective, single-arm, Phase II study evaluating sacituzumab tirumotecan combined with envafolimab in patients with TROP2-positive advanced biliary tract cancers who have progressed on first-line immunochemotherapy. Up to 28 eligible patients will be enrolled.After screening, eligible patients receive sacituzumab tirumotecan (5 mg\u002Fkg IV, d1, Q2W) plus envafolimab (300 mg SC, d1, Q2W) for 3 cycles, with subsequent treatment at the investigator's discretion.\n\nTumor imaging assessments per RECIST v1.1 are performed at Week 6, then every 6 weeks (up to 48 weeks) and every 12 weeks (thereafter) until disease progression, new therapy, loss to follow-up, or death. Post-treatment survival follow-up is conducted by phone every 3 months.\n\nThe study includes a safety run-in (6 patients) followed by an expansion phase using Simon's two-stage design (first stage: 15 patients; second stage: total 28 patients). The safety run-in stops if \\>2 DLTs occur; expansion proceeds if ≤2 DLTs. The trial is terminated if ≤1 objective response is observed in the first 15 expansion patients.\n\nThe primary endpoint is ORR(investigator-assessed per RECIST v1.1). Secondary endpoints include OS, PFS, DCR, DOR, safety, and tolerability.",[314],"Advanced Biliary Tract Cancers",[316,317,318,319],"antibody-drug conjugate","Biliary Tract Cancers","TROP2","immunotherapy","2026-07-22",{"date":257,"type":34},{"date":323,"type":23},"2026-08",{"date":325,"type":23},"2028-07",{"name":40,"class":41},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":24,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":42},"100648839","phase-2-fosrolapitant-combined-with-palonosetron-to-prevent-trastuzumab-rezetecan-related-cinv-100648839","NCT07726433","Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV","A Multicenter, Exploratory Clinical Study of the Efficacy and Safety of Phentolamine and Palonosetron for the Prevention of Nausea and Vomiting Associated With Recom-Trastuzumab Therapy","Inclusion Criteria:\n\n1. Sign a written informed consent form and voluntarily enroll in this study;\n2. Be at least 18 years of age; gender is not a restriction;\n3. Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;\n4. Have an ECOG performance status score of 0-2;\n5. No ascites or pleural effusion requiring drainage;\n6. No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction;\n7. Expected survival of ≥12 weeks;\n8. Good organ and bone marrow function, defined as follows:\n\n   Hematologic System (No blood transfusions or treatment with hematopoietic growth factors within the past 14 days)\n   * Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL\n   * Platelets (PLT) ≥ 100×10⁹\u002FL\n   * Hemoglobin (Hb) ≥ 90 g\u002FL Liver Function\n   * Total Bilirubin (TBIL) ≤ 1.5×ULN (For patients with Gilbert's syndrome: ≤ 3×ULN)\n   * Alanine Aminotransferase (ALT) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)\n   * Aspartate Aminotransferase (AST) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)\n   * Albumin (ALB) ≥ 30 g\u002FL Renal Function\n   * Creatinine (Cr) ≤ 1.5×ULN\n   * Creatinine Clearance (Ccr)\n   * (Calculated only when creatinine \\> 1.5×ULN) Endogenous creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula) Cardiac Function\n   * 12-lead electrocardiogram No severe arrhythmias, and a mean Fridericia-corrected QT interval (QTc) of \\\u003C450 ms (males) or \\\u003C470 ms (females)\n   * Echocardiogram Left ventricular ejection fraction (LVEF) ≥ 50%\n9. Agree to cooperate in completing daily nausea and vomiting logs and scale assessments;\n10. Understand the nature of this study; the patient and\u002For legal guardian voluntarily agree to participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Allergy to the study drug or its excipients;\n2. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;\n3. Nausea or vomiting at the time of enrollment requiring treatment with antiemetics;\n4. Use of medications with antiemetic effects within 2 days prior to the first dose;\n5. Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted);\n6. Presence of conditions affecting the assessment of vomiting, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;\n7. Patients who are difficult to enroll due to clinically diagnosed psychiatric disorders;\n8. Localized or active systemic infections requiring treatment;\n9. Pregnant or breastfeeding women, as well as patients of childbearing age who refuse to use appropriate contraceptive measures during the course of this trial;\n10. Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug (patients who failed screening for other clinical trials may be enrolled in this study);\n11. Patients with other factors deemed by the investigator to be unsuitable for participation in this study, such as any physiological or psychological conditions that may increase study risks, affect patient adherence to the protocol, or interfere with the patient's ability to complete the trial.",{"count":335,"type":23},56,[26],"This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up.\n\nDosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron.\n\nThe dosage regimen is as follows:\n\nDay 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy.\n\nObserve for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.",[339],"Chemotherapy-Induced Nausea and Vomiting (CINV)",{"date":341,"type":34},"2026-07-24",{"date":343,"type":34},"2026-06-15",{"date":345,"type":23},"2028-06-01",{"name":40,"class":41},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":24,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":42},"100648659","phase-2-study-on-sequential-cryoablation-relaforp-alpha-and-chemotherapy-for-bile-duct-tumors-100648659","NCT07726446","Study on Sequential Cryoablation, Relaforp Alpha, and Chemotherapy for Bile Duct Tumors","Safety and Effectiveness of Sequential Cryoablation With Rilafup α and Chemotherapy as First-line Treatment for Intrahepatic Cholangiocarcinoma and Gallbladder Cancer: a Multicenter, Prospective, Single-arm, Phase II Clinical Study","Inclusion Criteria:\n\n1. Age ≥18 years, any gender;\n2. Histologically confirmed unresectable locally advanced\u002Fmetastatic intrahepatic cholangiocarcinoma or gallbladder cancer;\n3. No prior anti-tumor treatment;\n4. At least one measurable target lesion according to RECIST 1.1 tumor evaluation criteria, and at least one lesion suitable for ablation;\n5. No active autoimmune disease;\n6. No concurrent malignancies;\n7. ECOG performance status 0-1;\n8. Expected survival ≥ 3 months;\n9. Adequate organ and bone marrow function (no transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks before first dose), defined as:\n\n   1. Blood count: neutrophils (NEUT) ≥ 1.2×10\\^9\u002FL; platelets (PLT) ≥ 90×10\\^9\u002FL; hemoglobin ≥ 90 g\u002FdL;\n   2. Liver function: AST and ALT ≤ 2.5× upper limit of normal (ULN); ALP ≤ 2.5×ULN; total bilirubin (TBIL) ≤ 1.5×ULN; if liver metastases, ALT and AST ≤ 5×ULN;\n   3. INR ≤ 1.25;\n   4. Serum creatinine ≤ 1.5× ULN or creatinine clearance (CrCl) ≥ 30 mL\u002Fmin (using Cockcroft-Gault formula);\n10. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective medical contraception from signing the informed consent until 6 months after the last dose;\n11. Participants voluntarily join the study, sign the informed consent form, and can comply with scheduled visits and related procedures.\n\nExclusion Criteria:\n\n1. Previously received systemic anti-tumor treatment;\n2. Active brain metastases; patients with asymptomatic brain metastases can be enrolled; for patients clinically suspected of central nervous system metastasis, a CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastasis;\n3. Had other malignant tumors within 5 years before administration (except tumors cured with radical treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.);\n4. Allergic to the study drug (Rilafup Alpha Injection, or other immune checkpoint inhibitors);\n5. History of unstable angina; newly diagnosed angina within 3 months before screening or myocardial infarction within 6 months before screening; arrhythmias (including QTcF: men ≥ 450 ms, women ≥ 470 ms) requiring long-term use of anti-arrhythmic drugs and NYHA class ≥ II heart failure;\n6. Urinalysis showing protein ≥ and confirmed 24-hour urine protein quantification \\> 1.0g;\n7. Infectious pneumonia, non-infectious pneumonia, interstitial pneumonia, or other conditions requiring corticosteroid therapy; history of chronic autoimmune diseases, such as systemic lupus erythematosus; history of ulcerative colitis, Crohn's disease, or other inflammatory bowel diseases; history of chronic diarrhea conditions like irritable bowel syndrome; history of sarcoidosis or tuberculosis; active hepatitis B or C, and HIV infection;\n8. Currently participating in interventional clinical research treatment, or have received other study drugs or devices within 4 weeks before first administration;\n9. History of substance abuse that cannot be stopped or mental disorders; Any other situation in which the investigator believes the patient is not suitable for participation in this study.",{"count":355,"type":23},30,[26],"This study is a prospective, multicenter, single-arm, open-label Phase II clinical trial, planned to enroll 30 patients with unresectable locally advanced or metastatic iCCA\u002FGBC. Patients will first receive cryoablation treatment, and two weeks after ablation, they will receive 8 cycles of immunotherapy combined with chemotherapy (Relatlimab α plus GC chemotherapy, every 3 weeks). During the maintenance phase, patients will continue with Relatlimab α alone, every 3 weeks, for up to one year. During the combination treatment phase, efficacy will be evaluated every 6 weeks, and during the maintenance phase, every 6 to 9 weeks. From the date of randomization\u002Fenrollment, survival follow-ups will be conducted every 3 months (±14 days) for the first 2 years; afterwards, follow-ups will occur every 6 months (±28 days) until the participant dies, is lost to follow-up, or the study ends, whichever comes first.",[359],"Biliary Tract Cancer (BTC)",{"date":341,"type":34},{"date":362,"type":23},"2026-10",{"date":364,"type":23},"2030-12",{"name":40,"class":41},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":24,"phases":375,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":42},"100648827","phase-1-multi-cohort-study-of-zeprumetostat-combinations-for-relapsedrefractory-ptcl-100648827","NCT07724782","Multi-Cohort Study of Zeprumetostat Combinations for Relapsed\u002FRefractory PTCL","A Multi Cohort Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat Combination Regimen in Relapsed\u002FRefractory Peripheral T Cell Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older, both males and females are eligible;\n2. Histologically confirmed peripheral T-cell lymphoma (PTCL) including PTCL-NOS and TFHL that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:\n\n   Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK\u002FT-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;\n3. Patients who have undergone prior hematopoietic stem cell transplantation are allowed;\n4. ECOG PS 0-2\n5. Life expectancy greater than 3 months.\n6. Adequate organ function\n7. Contraception during study\n8. Informed consented\n\nExclusion Criteria:\n\n1. Prior treatment with EZH2 inhibitors or EZH1\u002F2 inhibitors before enrollment;\n2. Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL;\n3. History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years;\n4. Central nervous system involvement (meningeal or parenchymal);\n5. Known hypersensitivity to any study drugs;\n6. Participation in another clinical trial of an investigational drug within 4 weeks prior to the start of the study.\n7. Pregnant or lactation\n8. Active infection.\n9. Diseases and medical history:\n\n   1. Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers\n   2. Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);\n   3. Has a history of psychoactive substance abuse that cannot be discontinued\n   4. Has any severe and\u002For uncontrolled disease.\n10. Uncontrollable autoimmune disease,\n11. Not able to comply to the protocol for mental or other unknown reasons\n12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":374,"type":23},33,[376,26],"PHASE1","This is a single-arm, multi-cohort, multicenter, phase Ib\u002FIIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents\u002Fregimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.",[379],"PTCL-NOS","2026-07-21",{"date":341,"type":34},{"date":383,"type":23},"2026-08-01",{"date":385,"type":23},"2031-07-30",{"name":40,"class":41},{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":24,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":401,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":42},"100604277","phase-2-tislelizumab-combined-with-chemotherapy-for-different-cycles-of-neoadjuvant-therapy-for-locally-advanced-resectable-squamous-cell-carcinoma-of-the-head-and-neck-neotempo-100604277","NCT07147426","Tislelizumab Combined With Chemotherapy for Different Cycles of Neoadjuvant Therapy for Locally Advanced Resectable Squamous Cell Carcinoma of the Head and Neck (NeoTempo)","A Prospective, Randomized Controlled, Phase II Clinical Study on the Neoadjuvant Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma With Tislelizumab Combined With Chemotherapy for Different Cycles (NeoTempo)","NeoTempo","Inclusion Criteria:\n\n* Histological or pathological diagnosis of head and neck squamous cell carcinoma;\n* Initially resectable stage III-IVB oral cancer\u002Flaryngeal cancer\u002Fhypopharyngeal cancer\u002FP16-oropharyngeal cancer, or stage III p16+ oropharyngeal cancer (AJCC 8th), and evaluated by the researcher to achieve R0 resection;\n* Plan to perform neoadjuvant therapy;\n* No previous anti-tumor treatment for HNSCC;\n* There is at least one measurable lesion;\n* Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2;\n* The expected survival period is ≥3 months\n* The functions of vital organs meet the following requirements (excluding any blood components and cell growth factors used within 7 days) :\n\n  i. Normal bone marrow reserve function, white blood cell (WBC) ≥3.0×109\u002FL; Neutrophil count (NEUT) ≥ 1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (Hb) ≥90 g\u002FL; ii. Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥50 ml\u002Fmin (Cockcroft-Gault formula); iii. Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is ≤ 2.5 times the upper limit of the normal value (ULN).\n* Be able to and willing to abide by the research and follow-up procedures;\n* Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment.\n* The patient voluntarily joined this clinical study, signed the informed consent form, had good compliance and was able to cooperate with the follow-up.\n\nExclusion Criteria:\n\n* Previously received anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T-cell co-stimulation or checkpoint pathways);\n* There is a clear history of allergies, and there may be potential allergies or intolerances to the research drug and its similar biological agents;\n* Participated in clinical trials of other anti-tumor drugs within 4 weeks before the first administration; Or within 4 weeks before the first administration or planning to receive a live attenuated vaccine during the study period;\n* Other malignant tumors have occurred within the past five years (except for well-treated squamous cell carcinoma of the skin or controlled basal cell carcinoma of the skin);\n* Immunosuppressive drugs have been used within 14 days prior to the first use of tislelizumab, excluding nasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg\u002F day of prednisolone or equivalent physiological doses of other corticosteroids).\n* Advanced patients with symptoms, who have spread to internal organs and are at risk of life-threatening complications in the short term (including those with uncontrollable large amounts of exudate \\[thoracic, pericardial, abdominal\\], pulmonary lymphangitis and more than 30% liver involvement)\n* Any active autoimmune diseases or a history of autoimmune diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma has completely relieved in childhood and do not require any intervention in adulthood can be included; Asthma subjects who require bronchodilators for medical intervention cannot be included.\n* Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the NYHA standard, patients with grade Ⅲ to Ⅳ cardiac failure, or those whose left ventricular ejection fraction (LVEF) is less than 50% as indicated by echocardiography; Myocardial infarction occurred within 6 months before enrollment, New York Heart Association Class II or above heart failure, uncontrolled angina pectoris, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram indicating acute ischemia or abnormal active conduction system\n* Concurrent severe infection within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs), or unexplained fever \\>38.5°C during the screening period\u002Fbefore the first administration;\n* Those with a history of abuse of psychotropic drugs and unable to quit, or those with mental disorders;\n* Major surgical operations have been performed within 4 weeks prior to the first administration. Or have an open wound or fracture;\n* Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C;\n* There is central nervous system metastasis;\n* Those with a history of hereditary or acquired bleeding or coagulation disorders (the specific inclusion is determined by the researcher);\n* Other circumstances where the researcher determines that one is not suitable to participate in this study.",{"count":396,"type":23},100,[26],"This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.",[400],"Head &Amp; Neck Squamous Cell Carcinoma",{"date":320,"type":34},{"date":403,"type":34},"2025-10-01",{"date":405,"type":23},"2029-10-20",{"name":40,"class":41},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":24,"phases":415,"briefSummary":416,"conditions":417,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":424,"leadSponsor":426,"locationsCount":4},"100648499","phase-2-butyrate-yogurt-for-cancer-constipation-100648499","NCT07723729","Butyrate Yogurt for Cancer Constipation","A Phase II Study on the Efficacy and Safety of Butyrate-Containing Short-Chain Fatty Acid Yogurt in Constipation in Patients With Gastrointestinal Malignancies","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically confirmed diagnosis of gastrointestinal malignancy.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n4. Confirmed \\\u003C 3 spontaneous bowel movements (CSBM) per week during the 1-week baseline period, accompanied by constipation-related symptoms (e.g., straining, hard\u002Flumpy stools, sensation of incomplete evacuation, etc.).\n5. Anticancer treatment regimen is expected to remain relatively stable during the study period.\n6. Willing and able to provide written informed consent and complete electronic diary entries.\n\nExclusion Criteria:\n\n1. Mechanical intestinal obstruction, active inflammatory bowel disease, severe rectal stricture, or acute abdomen.\n2. Absolute neutrophil count (ANC) \\\u003C 1.0 × 10⁹\u002FL or active infection.\n3. New initiation or major dose adjustment of prosecretory or prokinetic agents within the past 2 weeks.\n4. Allergy or hypersensitivity to dairy products or any component of the butyrate-containing yogurt formulation.\n5. Deemed unsuitable for enrollment by the investigator (e.g., poor compliance, cognitive impairment, or other conditions that may interfere with study participation).",{"count":355,"type":23},[26],"Constipation is a common yet underrecognized supportive care issue in cancer patients. Its consequences extend beyond physical discomfort to include impaired quality of life, reduced opioid adherence leading to inadequate analgesia, and increased risks of fecal impaction, emergency visits, and hospitalization. Current management strategies-including laxatives, stool softeners, prokinetics, and PAMORAs-remain suboptimal due to limited effects on gut dysbiosis, mucosal barrier dysfunction, and chronic inflammation, as well as issues related to polypharmacy, variable efficacy, and long-term tolerability. Hence, there is a clear need for novel, well-tolerated, long-term interventions with nutritional benefits that target the gut microbiota-mucosal barrier-motility axis.\n\nShort-chain fatty acids (SCFAs), particularly butyrate, are key microbial metabolites that may improve constipation through multiple mechanisms: enhancing intestinal motility via enteric nervous system regulation, reinforcing mucosal barrier integrity and mitigating low-grade inflammation, and restoring gut microbial-metabolite homeostasis. Butyrate supplementation therefore holds mechanistic promise for cancer-related constipation.\n\nThe \"Small Blue Can High Dietary Fiber Butyrate SCFA Yogurt\" (Blueglass) is designed with a \"probiotics + prebiotics + acids\" synergistic fermentation platform, delivering ≥70 mg\u002F100 g butyrate combined with high dietary fiber. Compared with conventional laxatives or single-agent butyrate, this yogurt-based formulation offers potential advantages in patient acceptability, long-term adherence, dual exogenous and endogenous SCFA support, and multi-target action on motility, microbiome, and barrier function, making it a promising candidate for supportive care in this population.",[418,419],"Constipation","Gastrointestinal Cancer","2026-07-20",{"date":422,"type":34},"2026-07-23",{"date":383,"type":23},{"date":425,"type":23},"2027-12-30",{"name":40,"class":41},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":433,"eligibilityCriteria":434,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":435,"targetDuration":4,"studyType":24,"phases":437,"briefSummary":438,"conditions":439,"keywords":441,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":42},"100648238","phase-2-early-response-guided-sequential-radiotherapy-after-chemoimmunotherapy-for-locally-advanced-esophageal-squamous-cell-carcinoma-100648238","NCT07721103","Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma","Early Response-guided Sequential Radiotherapy After Chemoimmunotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Phase II Clinical Study","Keystone006","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following criteria:\n\nProvide written informed consent before enrollment.\n\nAge \\>18 years, male or female.\n\nHistologically confirmed thoracic esophageal squamous cell carcinoma (ESCC).\n\nLocally advanced, resectable disease according to AJCC\u002FUICC 8th edition TNM staging system, defined as:\n\ncT3-4aN0-2M0 or cT1-2N1-2M0;\n\nNo evidence of distant metastasis;\n\nConsidered initially resectable by a multidisciplinary surgical team.\n\nPatients who have received neoadjuvant chemoimmunotherapy and have measurable disease response assessment according to RECIST v1.1, including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD).\n\nAt least one measurable lesion according to RECIST version 1.1.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExpected survival time \\>6 months.\n\nAdequate organ function meeting the following criteria:\n\nBone marrow function:\n\nAbsolute neutrophil count ≥1,500\u002Fmm³;\n\nPlatelet count ≥100,000\u002Fmm³;\n\nHemoglobin ≥9 g\u002FdL.\n\nRenal function:\n\nSerum creatinine ≤1.5 mg\u002FdL and\u002For creatinine clearance ≥60 mL\u002Fmin.\n\nHepatic function:\n\nTotal bilirubin ≤1.5 × upper limit of normal (ULN);\n\nAST and ALT ≤1.5 × ULN.\n\nParticipants of childbearing potential must agree to use medically approved contraception during study treatment and for 3 months after completion of treatment. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment and must not be breastfeeding.\n\nWillingness and ability to comply with study procedures, safety assessments, and survival follow-up.\n\nExclusion Criteria:\n\n\\-\n\nParticipants will be excluded if any of the following criteria apply:\n\nEvidence of distant metastasis.\n\nPrevious or concurrent malignancy, except adequately treated basal cell carcinoma of skin or cervical carcinoma in situ.\n\nPrevious thoracic radiotherapy.\n\nPrevious treatment with PD-1, PD-L1, or CTLA-4 inhibitors, or known hypersensitivity to PD-1 inhibitors or macromolecular protein products.\n\nActive autoimmune disease or history of clinically significant autoimmune disease requiring systemic treatment.\n\nCurrent use of immunosuppressive therapy or systemic corticosteroids exceeding the equivalent of prednisone 10 mg\u002Fday within 2 weeks before enrollment.\n\nClinically significant ascites or pleural effusion requiring therapeutic drainage.\n\nUncontrolled cardiovascular disease, including:\n\nNYHA class II or higher heart failure;\n\nUnstable angina;\n\nMyocardial infarction within 1 year;\n\nClinically significant arrhythmias requiring treatment.\n\nSignificant coagulation abnormalities, bleeding tendency, or ongoing thrombolytic\u002Fanticoagulant therapy.\n\nActive gastrointestinal disorders associated with bleeding or perforation risk, including esophageal varices, active gastric\u002Fduodenal ulcer, ulcerative colitis, portal hypertension, or active tumor bleeding.\n\nHistory of severe bleeding, clinically significant hemoptysis, or thromboembolic events within specified periods.\n\nActive infection or unexplained fever \\>38.5°C before treatment initiation.\n\nAbdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks before study treatment.\n\nHistory or evidence of interstitial lung disease, pulmonary fibrosis, radiation pneumonitis, drug-induced pneumonitis, pneumoconiosis, or severe pulmonary impairment.\n\nKnown immunodeficiency, including HIV infection, or active hepatitis infection requiring exclusion according to protocol criteria.\n\nParticipation in another clinical trial within 1 month before enrollment or concurrent systemic anticancer therapy.\n\nReceipt of live vaccines within 4 weeks before treatment or planned live vaccination during study treatment.\n\nKnown history of substance abuse, alcoholism, or drug abuse.\n\nInability or unwillingness to comply with study-related procedures, examinations, or required costs.\n\nAny other medical, psychological, social, or safety-related condition judged by the investigator to make the participant unsuitable for study participation.",{"count":436,"type":23},110,[26],"Esophageal squamous cell carcinoma (ESCC) is a common and aggressive malignancy with poor prognosis, particularly in patients with locally advanced disease. Neoadjuvant chemoimmunotherapy has shown promising antitumor activity and may improve pathological response; however, a proportion of patients achieve only stable disease (SD) or progressive disease (PD) after initial treatment and may have limited benefit from proceeding directly to surgery.\n\nThis prospective, single-center, phase II clinical study aims to evaluate an early response-guided sequential selective radiotherapy strategy after neoadjuvant chemoimmunotherapy in patients with locally advanced, resectable ESCC. Patients will initially receive neoadjuvant chemotherapy combined with PD-1 inhibitor therapy. Based on radiological response assessment, patients with major response (complete response or partial response) will proceed directly to radical surgery, whereas patients with insufficient response (stable disease or progressive disease but still considered resectable) will receive sequential chemoradiotherapy followed by surgery.\n\nThe study aims to assess the safety and efficacy of this individualized treatment strategy, with primary evaluation focusing on pathological response, surgical outcomes, and treatment-related adverse events. Exploratory analyses will investigate potential biomarkers associated with treatment response and prognosis.",[440],"Esophageal Squamous Cell Carcinoma (ESCC)",[442,443,444,445],"Locally advanced esophageal cancer","Neoadjuvant therapy","Adaptive treatment strategy","Response-guided therapy","2026-07-19",{"date":320,"type":34},{"date":449,"type":23},"2026-07-14",{"date":451,"type":23},"2031-12-31",{"name":40,"class":41},{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":460,"targetDuration":4,"studyType":24,"phases":461,"briefSummary":462,"conditions":463,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":468,"leadSponsor":470,"locationsCount":471},"100647680","phase-2-ak112-combination-therapy-as-first-line-treatment-for-metastatic-digestive-system-neuroendocrine-cancer-100647680","NCT07712094","AK112 Combination Therapy as First Line Treatment for Metastatic Digestive System Neuroendocrine Cancer","A Prospective, Parallel, Double-cohort, Multicenter Phase II Clinical Study of Ivonescimab (AK112) Combined With IP Chemotherapy ± TACE for First-line Treatment of Metastatic Digestive System Neuroendocrine Cancer","Inclusion Criteria:\n\n1. Age: 18 - 75 years old;\n2. Metastatic digestive system neuroendocrine carcinoma (NEC) confirmed by tissue or cytological examination;\n3. For cohort 2 only: Liver metastasis, suitable for TACE;\n4. No previous systemic treatment; For patients who received adjuvant therapy, disease recurrence and metastasis more than 6 months after the last treatment can be regarded as first-line treatment;\n5. Clear measurable lesions meeting the requirements of RECIST (1.1); If the lesion that received previous local treatment (radiation, ablation, vascular intervention, etc.) is the only lesion, there must be clear imaging evidence of disease progression for this lesion;\n6. ECOG score of 0 or 1;\n7. Expected survival ≥ 12 weeks;\n8. Basic normal functions of major organs and bone marrow;\n9. Male or female patients with reproductive capacity voluntarily use effective contraceptive methods during the study period and within 6 months after the last study medication, such as double barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female patients will be considered to have reproductive capacity, unless the female patient has naturally menopause, artificial menopause or sterilization (such as hysterectomy, bilateral ovary removal or radiotherapy of the ovaries, etc.).\n10. Have fully understood this study, voluntarily participated, and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Within the past 5 years, have been diagnosed with other malignant tumors (excluding carcinoma in situ, basal cell carcinoma, etc.);\n2. Known to be allergic to any component of any study drug; have a history of severe hypersensitivity reaction to other monoclonal antibodies;\n3. Within 4 weeks before enrollment, have received approved or investigational systemic anti-tumor treatment, including: photodynamic therapy, chemotherapy, radical radiotherapy, ablation, local radiotherapy (allowing for palliative radiotherapy for bone metastases at least 2 weeks before the study drug treatment), biological immunotherapy, targeted therapy, etc.;\n4. Within 4 weeks before enrollment, have participated in other domestic clinical trials of drugs that have not been approved or are not yet on the market and have received corresponding trial drug treatment;\n5. Within 4 weeks before enrollment, have received any surgery or invasive treatment or operation (except for intravenous catheterization, puncture drainage, etc.);\n6. The patient currently has active ulcers in the stomach and duodenum, ulcerative colitis and other digestive tract diseases or active bleeding from the unresected tumor, or conditions that the investigator deems may cause gastrointestinal bleeding or perforation;\n7. Within 3 months before enrollment, have obvious evidence or history of bleeding (more than 30 mL of bleeding within 3 months, hematemesis, black stool, bloody stool), hemoptysis (more than 5 mL of fresh blood within 4 weeks), or have had a thromboembolic event within 12 months (including stroke events and\u002For transient ischemic attacks);\n8. Have significant clinical cardiovascular diseases, including but not limited to acute myocardial infarction within 6 months before enrollment, severe\u002Funstable angina pectoris or coronary artery bypass surgery; New York Heart Association (NYHA) class \\> 2 for congestive heart failure; Drug treatment for ventricular arrhythmias; Electrocardiogram (ECG) showing QTc interval ≥ 480 milliseconds;\n9. Unstable brain parenchymal metastases, spinal cord metastases or compression, cancerous meningitis or meningitis metastasis;\n10. Have third space fluid that cannot be controlled by drainage methods (such as large amounts of ascites, pleural effusion, pericardial effusion, etc.), and the subjects need to control the third space fluid through drainage within 14 days before administration;\n11. Active or uncontrolled severe infection (≥ CTCAE grade 2 infection);\n12. Known human immunodeficiency virus (HIV) infection; Known significant liver disease history, including viral hepatitis \\[must exclude active HBV infection if the HBV DNA is positive (\\> 1×10\\^4 copies\u002FmL or \\> 2000 IU\u002Fml); known hepatitis C infection (HCV) and HCV RNA positive (\\> 1×10\\^3 copies\u002FmL), or other hepatitis, liver cirrhosis\\];\n13. Known mental illness, drug abuse, alcoholism or drug addiction history.\n14. Pregnant or lactating women.\n15. Have any disease, treatment, laboratory test abnormalities in the past or currently, which may confuse the research results, affect the full participation of the subjects in the research, or the participation in the research may not be in the best interests of the subjects.\n16. Local or systemic diseases not caused by malignant tumors, or secondary diseases or symptoms of tumors, which may lead to higher medical risks and\u002For uncertainty in survival period evaluation, such as tumor leukemia reaction (white blood cell count \\> 20×109\u002FL), cachexia manifestations (such as weight loss of more than 10% within 3 months before screening), etc.\n17. Patients judged by the investigator to be unsuitable to participate in this study.",{"count":335,"type":23},[26],"This study is a single prospective, parallel, double-cohort, multicenter phase II clinical trial, aiming to evaluate the efficacy and safety of ivonescimab (AK112) combined with IP chemotherapy ± TACE in the first-line treatment of metastatic digestive system neuroendocrine cancer.",[464],"Neuroendocrine Cancer",{"date":466,"type":34},"2026-07-17",{"date":383,"type":23},{"date":469,"type":23},"2029-08-31",{"name":40,"class":41},8,{"id":473,"slug":474,"hasResults":12,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":24,"phases":481,"briefSummary":482,"conditions":483,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":487,"leadSponsor":488,"locationsCount":4},"100646786","phase-2-becotatug-vedotin-plus-tislelizumab-and-low-dose-lenvatinib-for-advanced-esophageal-squamous-cell-carcinoma-phase-ii-100646786","NCT07686926","Becotatug Vedotin Plus Tislelizumab and Low-Dose Lenvatinib for Advanced Esophageal Squamous Cell Carcinoma, Phase II","Becotatug Vedotin Combined With Tislelizumab and Low-Dose Lenvatinib in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Failed First-Line Therapy: A Phase II Exploratory Study","Inclusion Criteria:\n\n1.Age ≥ 18 years, male or female. 2.Histopathologically or cytologically confirmed recurrent or metastatic esophageal squamous cell carcinoma.\n\n3.Failed first-line or above standard systemic therapy for advanced disease. 4.Patients must be able to provide tumor specimens (paraffin blocks, paraffin-embedded sections, or fresh tissue sections) from primary or metastatic lesions for pathological testing. The most recent archived tumor tissue specimen may be used. If archived tissue is unavailable, a new biopsy is required.\n\n5.ECOG PS 0-2. 6.Expected survival ≥ 3 months. 7.At least one measurable target lesion assessable by CT or MRI according to RECIST version 1.1 criteria.\n\n8.Adequate organ and bone marrow function, as demonstrated by the following laboratory values:\n\n1. Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL；Platelet count (PLT) ≥ 100×10⁹\u002FL；Hemoglobin (HGB)≥90 g\u002FL.\n2. Liver: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤2.5×ULN; for patients with liver metastases, ALT and AST≤5×ULN.\n3. Kidney: Creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n4. Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (except for patients receiving therapeutic anticoagulation).\n5. Cardiac function: No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%.\n\n9.Female patients of childbearing potential must agree to use contraception during the study and for 6 months after the end of study participation, have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must not be breastfeeding. Male patients must agree to use contraception during the study and for 6 months after the end of study participation.\n\n10.Patients must be able and willing to comply with the scheduled visits, treatment plans, laboratory tests, and other study-related procedures as outlined in the protocol.\n\n11.Patients must be able to understand the study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n1. Prior malignancy within 5 years, except for carcinoma in situ, basal cell carcinoma, or other malignancies considered cured with negligible risk of recurrence.\n2. Known hypersensitivity to any component of the study regimen.\n3. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation.\n4. Untreated or unstable parenchymal brain metastases, spinal cord metastasis or compression, leptomeningeal disease, or meningeal metastases.\n5. Evidence of active infection, including:1）Hepatitis B (HBsAg positive with HBV DNA ≥ 2000 IU\u002FmL, excluding drug-induced or other causes of hepatitis);2）Hepatitis C (anti-HCV antibody positive with HCV RNA above the lower limit of detection);3）Human immunodeficiency virus (HIV) infection;4）Uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections that have not resolved prior to study drug administration.\n6. Third-space fluid that cannot be controlled by drainage (e.g., massive ascites, pleural effusion, pericardial effusion), or subjects requiring drainage to control third-space fluid within 14 days prior to first dose.\n7. Any severe or uncontrolled systemic disease in the investigator's judgment.\n8. Poorly controlled cardiac disease, including:\n\n1）Heart failure \\> New York Heart Association (NYHA) class II; 2）Unstable angina pectoris; 3）Myocardial infarction within 1 year; 4）Clinically significant supraventricular or ventricular arrhythmias requiring treatment; 5）Long QT syndrome, with QTcF \\> 450 ms (male) or QTcF \\> 470 ms (female). 9.History of primary immunodeficiency or active autoimmune disease, or current use of immunosuppressants or systemic corticosteroids (≥ 10 mg\u002Fday prednisone or equivalent) continuing within 2 weeks prior to enrollment.\n\n10.History of or concomitant interstitial lung disease (ILD), radiation pneumonitis, severe chronic obstructive pulmonary disease (COPD), severe pulmonary insufficiency, or symptomatic bronchospasm.\n\n11.Positive serum pregnancy test or breastfeeding females who do not agree to use adequate contraception during the study and for 6 months after the last dose of study drug.\n\n12.History of organ transplantation, including allogeneic peripheral stem cell or bone marrow transplantation.\n\n13.Peripheral neuropathy ≥ Grade 2 (per CTCAE version 5.0). 14.Prior receipt of any of the following treatments:\n\n1. Intravenous antibiotic therapy within 7 days prior to first dose.\n2. Investigational drug from another clinical trial within 4 weeks prior to first dose.\n3. Live attenuated vaccine within 4 weeks prior to first dose. Inactivated seasonal influenza vaccines or approved non-replicating COVID-19 vaccines are permitted.\n4. Systemic immunostimulatory agents (including but not limited to interferon, interleukin-2, etc.) within 4 weeks prior to first dose.\n5. Major surgical procedure (e.g., abdominal or thoracic surgery, excluding diagnostic puncture, infusion device placement, or gastrointestinal stent placement) within 4 weeks prior to first dose, or anticipation of major surgery not directed at the tumor during the study treatment period.\n\n   15.History of substance abuse (psychoactive drugs) that cannot be abstained from, or psychiatric disorders.\n\n   16.Concurrent participation in another interventional clinical study. 17.Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.",{"count":480,"type":23},36,[26],"Immunotherapy combined with chemotherapy has become the first-line standard of care for advanced esophageal squamous cell carcinoma (ESCC), significantly improving patient survival. However, with the widespread adoption of first-line immunotherapy, most patients eventually develop immune resistance. After first-line treatment failure, there is currently no established standard effective therapy for second-line ESCC. Therefore, more effective and safer treatment options are urgently needed for second-line advanced ESCC.\n\nThis is a prospective, single-arm, single-center, open-label, Phase II clinical study aiming to evaluate the efficacy and safety of Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib in patients with advanced ESCC who have failed first-line therapy. Eligible patients will receive Becotatug Vedotin combined with Tislelizumab and low-dose Lenvatinib. The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DOR), overall survival (OS), and safety.",[295],{"date":485,"type":34},"2026-07-16",{"date":383,"type":23},{"date":300,"type":23},{"name":40,"class":41},{"id":490,"slug":491,"hasResults":12,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":24,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":42},"100644115","phase-2-neoadjuvant-egfr-adc-combined-with-anti-pd-1-monoclonal-antibody-in-resectable-locally-advanced-hypopharyngeal-squamous-cell-carcinoma-100644115","NCT07665190","Neoadjuvant EGFR-ADC Combined With Anti-PD-1 Monoclonal Antibody in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","A Multicenter, Phase II Clinical Trial of Neoadjuvant Becotatug Vedotin Combined With Pucotenlimab in Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma","RESERVE-HC","Inclusion Criteria:\n\n1. Aged ≥ 18, male or female;\n2. Histopathologically confirmed Hypopharyngeal Squamous Cell Carcinoma;\n3. Surgically resectable, Clinical Stage III or IV and no distant metastasis (AJCC 8th edition);\n\n3\\. Measurable primary lesions per RECIST v1.1; 5.Treatment-naive (no prior anti-tumor therapy for current disease); 6.ECOG performance status 0-1; 7.Estimated life expectancy \\>= 3 months; 8.Have adequate organ function as defined by laboratory parameters; 9.No contraindications to chemotherapy, targeted therapy, or immunotherapy; 10.No history of immune-related diseases; 11.No uncontrolled pneumonia or pulmonary infection; 12.Female participants of childbearing potential must agree to use effective contraception during the trial; A serum or urine pregnancy test must be negative within 72 hours prior to the start of chemotherapy; 13.The subject is volunteer to participate, and the subject must signed an informed consent form (ICF), indicating that it understands the purpose of this study and the required procedures, and is willing to participate in the study. Subjects must be willing and abide by prohibition and restrictions specified in the research program; Subjects are willing and able to follow the trial and follow-up procedures.\n\nExclusion Criteria:\n\n1. Patients with distant metastasis;\n2. Patients with uncontrolled severe medical conditions;\n3. Patients with a history of allergy or hypersensitivity to any component of monoclonal antibody therapies;\n4. Uncontrolled cardiac clinical symptoms or diseases;\n5. Occurrence of severe infection (CTCAE Grade \\> 2) within 4 weeks prior to the first dose of the study drug;\n6. Unexplained fever \\> 38.5°C during the screening period or before the first dose;\n7. Active autoimmune disease or a history of autoimmune disease;\n8. History of immunodeficiency, or a history of organ transplantation or allogeneic bone marrow transplantation;\n9. Patients with untreated chronic hepatitis B, or chronic hepatitis B virus (HBV) DNA exceeding 500 IU\u002FmL, or patients with active hepatitis C virus (HCV) must be excluded;\n10. History of interstitial lung disease;\n11. Patients with active pulmonary tuberculosis infection identified by medical history or CT scan;\n12. Patients who have received any of the following treatments:\n\n    A. Receipt of any investigational drug or anti-cancer therapy within 4 weeks prior to the first dose of the study drug; B. Requirement for systemic treatment with corticosteroids (daily dose \\> 10 mg prednisone equivalent) or other immunosuppressive medications within 2 weeks prior to the first dose of the study drug.; C. Prior vaccination with an anti-tumor vaccine or receipt of a live vaccine within 4 weeks prior to the first dose of the study drug; D. Major surgery or significant traumatic injury within 4 weeks prior to the first dose of the study drug; E. Concurrent enrollment in another clinical study;\n13. Dementia, altered mental status, or any psychiatric condition that would interfere with understanding or providing informed consent or completing questionnaires;\n14. Subjects with peripheral neuropathy ≥ Grade 2 according to CTCAE V5.0;\n15. History of allergy or hypersensitivity to any component of the study treatment;\n16. History of a primary malignancy other than head and neck squamous cell carcinoma within the previous 5 years;\n17. Requirement for concurrent treatment with other anti-tumor therapies;\n18. Patients deemed unsuitable for enrollment by the investigator;\n19. Pregnant or breastfeeding women.",{"count":498,"type":23},52,[26],"This clinical trial aims to evaluate the efficacy and safety of Becotatug Vedotin (EGFR-ADC) in combination with Pucotenlimab(Anti-PD-1 Monoclonal Antibody) as neoadjuvant therapy for patients with Resectable Locally Advanced Hypopharyngeal Squamous Cell Carcinoma.\n\nThe primary objective is the pathological complete response(pCR)rate following neoadjuvant therapy. The secondary objective includes the major pathological response(MPR)rate following neoadjuvant therapy, the objective response rate (ORR), Organ preservation rate, Surgery postponement rate, event-free survival (EFS), overall survival(OS), and safety.",[502],"Hypopharyngeal Squamous Cell Carcinoma",{"date":485,"type":34},{"date":505,"type":23},"2026-07-01",{"date":173,"type":23},{"name":40,"class":41},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":515,"enrollmentInfo":516,"targetDuration":4,"studyType":24,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":521,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":42},"100538582","a-single-arm-clinical-trial-of-percutaneous-splenic-ablation-combined-with-splenic-artery-occlusion-for-secondary-hypersplenism-100538582","NCT06292715","A Single-Arm Clinical Trial of Percutaneous Splenic Ablation Combined With Splenic Artery Occlusion for Secondary Hypersplenism.","A Single-Arm Clinical Study Evaluating Microwave Ablation of the Spleen Combined With Splenic Artery Occlusion for Secondary Hypersplenism Treatment","Inclusion Criteria:\n\n* 1\\. written informed consent signed prior to enrolment 2. age \\> 18 years, both sexes 3.Patients with severe hypersplenism secondary to cirrhosis with clinical diagnosis, White blood cells \\\u003C3×109\u002FL, and\u002For platelet \\\u003C50×109\u002FL 4.Patients who have been repeatedly given drugs to raise white blood cells and platelets in clinical practice have poor effect 5.Mental problems such as clinical symptoms or anxiety in patients require interventional treatment for hypersplenism\n\nExclusion Criteria:\n\n* Patients with any of the following are not eligible for enrollment in this study\n\n  1. Coagulopathy or other blood disorders\n  2. Recent use of anticoagulant drugs\n  3. Severe hypertension and cardiac insufficiency\n  4. Bone marrow aspiration results showed bone marrow suppression\n  5. Combined with other spleen malignant diseases\n  6. Severe skin infection at the puncture site\n  7. Participated in other clinical studies within 2 months prior to the start of the study\n  8. Patient or his\u002Fher authorized person is unwilling to sign a written informed consent form or unwilling to comply with the study protocol","65 Years",{"count":248,"type":23},[140],"This study assesses the effectiveness of microwave ablation of the spleen in conjunction with splenic artery occlusion for treating secondary hypersplenism.",[520],"Secondary Hypersplenism",{"date":485,"type":34},{"date":523,"type":34},"2024-01-20",{"date":525,"type":23},"2026-12-31",{"name":40,"class":41},{"id":528,"slug":529,"hasResults":12,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":534,"targetDuration":4,"studyType":24,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":544,"locationsCount":42},"100488490","phase-2-durvalumab-combined-with-chemotherapy-neoadjuvant-therapy-of-biliary-tract-cancer-100488490","NCT05640791","Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer","Phase II, Single-arm, Exploratory Study to Evaluate the Safety and Effectiveness of Durvalumab Combined With Chemotherapy Neoadjuvant Therapy of Biliary Tract Cancer","Inclusion Criteria:\n\n1. The pathological diagnosis has confirmed biliary tract malignancy;pathological evidence may be obtained from biopsy\u002Fpuncture, surgical resection specimens, or a formal pathology report.\n2. Computed tomography (CT) or magnetic resonance imaging (MRI) shall be performed with high-quality cross-sectional imaging, and diagnosed as resectable high-risk biliary malignant tumors, limited to the liver, bile duct and\u002For regional lymph nodes (at least one of the following criteria must be met) :\n\n   * T-stage ≥ Ib (Ib-IV)\n   * Solitary lesion \\> 5 cm\n   * Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable\n   * Presence of major vascular invasion but still technically resectable\n   * Suspicious or involved regional lymph nodes (N1)\n   * No distant extrahepatic disease (M0)\n3. The patient's gender is not limited, and the age is 18-75 years old; Life expectancy\\>3 months;\n4. Within one week of enrollment, the ECOG PS score was 0 or 1;\n5. No serious complications, such as hypertension, coronary heart disease and psychiatric history, and no serious allergic history; Non pregnancy and non lactation period;\n6. The patient's organ and blood system functions meet the requirements:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL\n   * Platelet count ≥ 100 × 10\\^9\u002FL\n   * Hemoglobin ≥ 90 g\u002FL\n   * Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) and alanine aminotransferase ≤ 2.5 x ULN\n   * Albumin ≥ 3g\u002FdL\n   * Creatinine ≤ 1.5 x ULN\n7. The patient can understand and sign the informed consent form to participate in the trial study; can follow up with good compliance.\n\nExclusion Criteria:\n\n1. Patients who received PD-1, PD-L1, PD-L2, CTLA-4 inhibitors before enrollment, or patients who directly received another stimulatory or co inhibitory T cell receptor (such as CTLA-4, CD137);\n2. Used any other research drugs within 4 weeks before enrollment;\n3. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism after hormone replacement therapy); Patients with childhood asthma who have completely alleviated and do not need any intervention or leukorrhea after adulthood can be included, but patients who need medical intervention with bronchodilators cannot be included;\n4. With congenital or acquired immune deficiency, such as people infected with human immunodeficiency virus (HIV), active hepatitis B (HBV DNA 500IU\u002Fml), hepatitis C (hepatitis C antibody is positive, and HCV-RNA is higher than the detection limit of the analytical method) or people with hepatitis B and hepatitis C co infection;\n5. Severe infection (such as intravenous drip of antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first drug administration, or fever of unknown cause\\>38.5 ° C occurred during screening\u002Fbefore the first drug administration;\n6. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n7. Test drug allergy;\n8. Suffering from uncontrollable mental illness;\n9. Peripheral neuropathy of grade 2 or above according to CTCAE 4.0. In CTCAE 4.0, grade 2 sensory neuropathy is defined as \"moderate symptoms; restriction of activities of daily living (ADL)\";\n10. Occurrence of serious and\u002For uncontrollable diseases at the same time may affect participation in the study, such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, diabetes out of control, severe activity, uncontrollable infection after inadequate biliary drainage (such as tumor blocking the bile duct), or mental disease\u002Fsocial condition;\n11. Pregnancy (positive pregnancy test) or lactation;\n12. Diseases of central nervous system (CNS), except for brain metastasis treated. The treated brain metastatic tumor is defined as confirmed by clinical examination and brain imaging (MRI or CT) during the screening period, and there is no sign of progress or bleeding after treatment, and there is no need for continuous application of dexamethasone. Anticonvulsant drugs (stable dosage) are allowed. The treatment of brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; gamma knife, linear accelerator \\[LINAC\\] or equivalent) or a combination deemed appropriate by the treating doctor. Patients with central nervous system metastasis who underwent neurosurgical resection or brain biopsy within 3 months before the first day were excluded;\n13. Other cancers in the past (within the past 5 years) or at the same time, excluding non melanoma skin cancer and carcinoma in situ;\n14. History of allergy or hypersensitivity to any study drug;\n15. Current abuse of alcohol or illicit drugs;\n16. Unable or unwilling to sign the informed consent form.",{"count":535,"type":23},40,[26],"This phase II trial studies how well gemcitabine, cisplatin, nab-paclitaxel and durvalumab work before surgery in treating participants with Biliary Tract Cancer. The international multicenter phase III clinical study TOPAZ-1 has confirmed that durvalumab combined with gemcitabine and cisplatin can bring survival benefits to advanced BTC. Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy and Durvalumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.",[539],"Resectable Biliary Tract Cancer",{"date":485,"type":34},{"date":542,"type":34},"2023-01-12",{"date":525,"type":23},{"name":40,"class":41},""]