[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Henan Cancer Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":588},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,98,0,25,[9,46,69,96,118,142,163,190,212,239,268,290,314,334,355,378,398,418,439,459,482,505,524,543,565],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100652865","neoadjuvant-chemoradiotherapy-versus-neoadjuvant-immunochemotherapy-for-resectable-esophageal-cancer-a-target-trial-emulation-study-100652865",false,"NCT07778056","Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Immunochemotherapy for Resectable Esophageal Cancer: A Target Trial Emulation Study","A Virtual Randomized Controlled Trial Comparing Neoadjuvant Chemoradiotherapy Versus Neoadjuvant Immunochemotherapy for Resectable Esophageal Cancer Based on Real-World Data: A Target Trial Emulation Study Protocol","TTE-ESCC","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of diagnosis.\n2. Histologically confirmed esophageal squamous cell carcinoma (ESCC).\n3. Clinical stage cT3-4a N0-2 M0 or cT2N+ M0 (AJCC 8th edition), with no distant metastasis (M1), based on clinical staging records available at Time Zero.\n4. ECOG performance status 0-1 (or proxy: total hospitalization days ≤14 days in the past year if ECOG PS is missing).\n5. No prior antitumor therapy for esophageal cancer (surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy).\n6. Curative surgical intent documented at Time Zero.\n\nExclusion Criteria:\n\n1. Distant metastasis (M1) or clinically determined unresectable disease.\n2. Active concurrent malignancy within 5 years prior to diagnosis (excluding basal cell carcinoma of the skin or carcinoma in situ).\n3. Severe comorbidities significantly limiting life expectancy or precluding neoadjuvant therapy (proxy: total hospitalization days \\>30 days in the past year).\n4. Pregnancy or lactation.\n5. Known contraindications or hypersensitivity to the study drugs.","ALL","18 Years",{"count":21,"type":22},400,"ESTIMATED","OBSERVATIONAL","Esophageal squamous cell carcinoma (ESCC) is highly prevalent in China, with most patients presenting with locally advanced disease. Neoadjuvant chemoradiotherapy (nCRT) is the current standard of care, while neoadjuvant immunochemotherapy (nICT) has emerged as a promising alternative. However, no large-scale randomized controlled trial has directly compared nICT versus nCRT for long-term overall survival (OS) in this population. This study aims to compare the causal effects of nICT versus nCRT on OS and other key outcomes in patients with resectable locally advanced ESCC using target trial emulation (TTE) methodology. This is a single-center, retrospective, observational cohort study using TTE. Data are derived from electronic health records (EHR) of esophageal cancer patients hospitalized at Henan Cancer Hospital between January 2013 and December 2025. Patients meeting eligibility criteria (age ≥18 years; histologically confirmed ESCC; clinical stage cT3-4a N0-2 M0 or cT2N+ M0; ECOG PS 0-1; no prior antitumor therapy) are assigned to nICT or nCRT groups based on actual treatment initiation. Propensity score overlap weighting is used to balance baseline covariates. The primary outcome is overall survival (OS). Secondary outcomes include event-free survival (EFS), pathological complete response (pCR) rate, tumor regression grade (TRG), R0 resection rate, and safety. This study will provide real-world causal evidence on the comparative effectiveness of nICT versus nCRT in the Chinese ESCC population.",[26],"Esophageal Squamous Cell Carcinoma (ESCC)",[28,29,30,31,32,33],"Esophageal Cancer","Squamous Cell Carcinoma","Neoadjuvant Immunochemotherapy","Neoadjuvant Chemoradiotherapy","Target Trial Emulation","Real-World Data","NOT_YET_RECRUITING","2026-08-17",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":22},"2026-08-20",{"date":42,"type":22},"2028-08-20",{"name":44,"class":45},"Henan Cancer Hospital","OTHER_GOV",{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100582224","phase-2-serplulimab-combined-with-chemotherapy-for-early-stage-hrher2--breast-cancer-100582224","NCT06860529","Serplulimab Combined With Chemotherapy for Early-stage HR+\u002FHER2- Breast Cancer","3.1 Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible:\n\nAge: ≥18 years old.\n\nClinical-pathological confirmation:\n\ncT2-cT4 breast cancer, or cT1c with axillary lymph node metastasis.\n\nHistopathologically confirmed HR+\u002FHER2- invasive breast cancer:\n\nER and\u002For PR positive (IHC nuclear staining ≥1%).\n\nHER2-negative (IHC 0 or 1+ without FISH testing, or IHC 2+ with FISH-negative amplification).\n\nKi67 ≥20%.\n\nClinically measurable lesions:\n\nMeasurable lesions confirmed by ultrasound, mammography, or MRI (optional) within 1 month prior to randomization.\n\nAdequate organ and bone marrow function (within 1 month prior to chemotherapy):\n\nAbsolute neutrophil count (ANC) ≥2.0 × 10\\^9\u002FL.\n\nHemoglobin ≥90 g\u002FL.\n\nPlatelet count ≥100 × 10\\^9\u002FL.\n\nTotal bilirubin \\\u003C1.5 × ULN (upper limit of normal).\n\nCreatinine \\\u003C1.5 × ULN.\n\nAST\u002FALT \\\u003C1.5 × ULN.\n\nCardiac function: Left ventricular ejection fraction (LVEF) ≥55% by echocardiography.\n\nReproductive status: Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to randomization.\n\nECOG performance status: ≤1.\n\nInformed consent: Signed written informed consent.\n\n3.2 Exclusion Criteria\n\nPatients meeting any of the following criteria will be excluded:\n\nEvidence of metastatic breast cancer:\n\nChest\u002Fabdominal CT and bone scan required at any time from diagnosis to randomization to exclude metastasis.\n\nPET\u002FCT may substitute for other imaging modalities.\n\nPrior systemic therapy: Chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for the current breast cancer.\n\nSecond primary malignancy, except:\n\nAdequately treated non-melanoma skin cancer.\n\nPrior immunotherapy: Treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other immune checkpoint inhibitors.\n\nImmune-related conditions:\n\nDiagnosed immunodeficiency or active autoimmune disease.\n\nSevere cardiopulmonary disease: Uncontrolled or clinically significant.\n\nActive hepatitis: Hepatitis B or C with detectable viral load.\n\nTransplant history: Prior organ or bone marrow transplantation.\n\nPregnancy or lactation: Pregnant or breastfeeding women.\n\nOther contraindications: Severe uncontrolled comorbidities deemed by investigators to contraindicate chemotherapy or PD-1 inhibitor therapy.",{"count":53,"type":22},357,"INTERVENTIONAL",[56],"PHASE2","The neoadjuvant treatment options commonly used for HR+\u002FHER2- breast cancer are mainly anthracycline sequential or combined with paclitaxel chemotherapy regimens. Several clinical studies have confirmed that albumin paclitaxel is more effective than solvent-based paclitaxel, and therefore, albumin paclitaxel in combination with epirubicin has also become a commonly used chemotherapy regimen in clinical practice.\n\nThe aim of this study was to explore the efficacy and safety of the Serplulimab combined with nab-paclitaxel and epirubicin in the neoadjuvant treatment of HR+\u002FHER2- breast cancer",[59],"HR+\u002FHER2- Breast Cancer","RECRUITING",{"date":62,"type":38},"2026-08-19",{"date":64,"type":38},"2025-04-15",{"date":66,"type":22},"2030-03-31",{"name":44,"class":45},1,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100651220","ai-driven-digital-twin-and-drug-simulation-for-esophageal-cancer-100651220","NCT07757022","AI-Driven Digital Twin and Drug Simulation for Esophageal Cancer","Construction of Artificial Intelligence Model for Esophageal Cancer Digital Twin Patients and Drug Efficacy Simulation Verification Based on Supercomputing Platform and Multi-Omics Data","ESCA-DT","Inclusion Criteria:\n\n1. Treatment-naïve patients with clinical stage locally advanced (T1N1-3M0 or T2-3N0-3M0) thoracic esophageal squamous cell carcinoma, according to the 8th UICC-TNM staging system.\n2. Cervical color Doppler ultrasound shows no suspicious metastatic lymph nodes, or patients with suspected lymph node metastasis on ultrasound who are eligible for three-field lymphadenectomy.\n3. No prior antitumor therapy for esophageal cancer (including chemotherapy, radiotherapy, or immunotherapy).\n4. Preoperative evaluation of organ function indicates no surgical contraindications.\n5. Adequate bone marrow, liver, and renal function, confirmed by the following laboratory tests performed within 7 days prior to enrollment:\n\n   * Hemoglobin ≥ 90 g\u002FL;\n   * White blood cell count ≥ 4.0 × 10\\^9\u002FL;\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n   * Platelet count ≥ 100 × 10\\^9\u002FL;\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN);\n   * ALT and AST ≤ 2.5 × ULN;\n   * International normalized ratio (INR) of prothrombin time ≤ 1.5 × ULN, with activated partial thromboplastin time (APTT) within normal range;\n   * Serum creatinine ≤ 1.5 × ULN.\n6. No prior chemotherapy, radiotherapy, or hormone therapy for malignant tumors; no history of other malignancies, except for prostate cancer patients who received hormone therapy and have achieved disease-free survival (DFS) \\> 5 years.\n7. Expected to achieve R0 resection.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 1.\n9. Life expectancy ≥ 3 months.\n10. Women of childbearing potential must agree to use effective contraceptive measures (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 6 months after study completion. Serum or urine pregnancy test must be negative within 7 days prior to enrollment, and patients must not be breastfeeding. Male patients must agree to use contraceptive measures during the study and for 6 months after study completion.\n11. Patients must voluntarily participate in the study, provide written informed consent, demonstrate good compliance, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Patients not meeting the inclusion criteria.\n2. Presence of multiple primary malignancies (synchronous or metachronous).\n3. Active infections requiring systemic treatment.\n4. Requirement for continuous systemic corticosteroid therapy (\\>10 mg\u002Fday prednisone or equivalent) for comorbid conditions.\n5. Unstable angina within 3 months or myocardial infarction within 6 months prior to enrollment.\n6. Psychiatric disorders that may affect study compliance.\n7. Known or concurrent hemorrhagic disorders.\n8. Female patients who are pregnant or breastfeeding.\n9. Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or other severe pulmonary impairment.\n10. Autoimmune diseases, immunodeficiency states, or history of organ transplantation.\n11. Known hypersensitivity to the study drugs (toripalimab, paclitaxel, cisplatin) or their excipients.\n12. Abnormal coagulation function (PT \\> 16s, APTT \\> 53s, TT \\> 21s, Fib \\\u003C 1.5 g\u002FL), bleeding tendency, or patients receiving thrombolytic or anticoagulant therapy.\n13. Bronchial asthma requiring intermittent use of bronchodilators or medical intervention.\n14. Active hepatitis B (HBV) or hepatitis C (HCV) infection. (Patients who are HBsAg positive or HBcAb positive may be eligible if HBV DNA is below the lower limit of detection\u002Fquantification; patients who are HCV antibody positive may be eligible if HCV RNA is below the lower limit of detection\u002Fquantification.)\n15. Human immunodeficiency virus (HIV) positivity.\n16. Any other condition that, in the investigator's judgment, may compromise patient safety, interfere with study compliance, or preclude successful completion of the study.","75 Years",{"count":21,"type":22},"This study aims to integrate multi-omics data (genomics, transcriptomics, proteomics) from esophageal cancer patients with artificial intelligence and digital twin technology to construct personalized virtual patient models that precisely simulate individual responses to targeted therapies. Through a drug simulation platform, this study will rapidly screen potential effective drug combinations and optimize dosage and treatment regimens. The project attempts to replace portions of traditional clinical trials with virtual clinical trial technology, substantially shortening the R\\&D cycle, reducing costs, and effectively addressing the complexity of individualized treatment. Specifically, this study will conduct a head-to-head virtual clinical trial parallel to a real-world investigator-initiated trial (IIT) in patients with locally advanced esophageal squamous cell carcinoma, comparing the efficacy predictions from the virtual model with actual clinical outcomes. The ultimate goal is to explore the application of large-scale AI models in esophageal cancer targeted therapy, provide personalized treatment recommendations, and advance the implementation of precision medicine in esophageal cancer.",[28],[28,82,83,84,85,86,87],"Computational Medicine","Multi-Omics","Artificial Intelligence","Virtual Clinical Trials","Digital Twin","Toripalimab","2026-08-10",{"date":90,"type":38},"2026-08-11",{"date":92,"type":22},"2026-07-30",{"date":94,"type":22},"2028-12",{"name":44,"class":45},{"id":97,"slug":98,"hasResults":12,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":104,"targetDuration":4,"studyType":54,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":68},"100642953","phase-3-surgery-vs-radical-chemoradiotherapy-for-esophageal-scc-after-neoadjuvant-immunochemotherapy-100642953","NCT07629817","Surgery vs. Radical Chemoradiotherapy for Esophageal SCC After Neoadjuvant Immunochemotherapy","A Multicenter, Open-Label, Randomized Controlled Phase III Clinical Trial Comparing Surgery Versus Radical Chemoradiotherapy (Organ Preservation) in Patients With Thoracic Esophageal Squamous Cell Carcinoma Achieving cCR or cPR Following Neoadjuvant Immunochemotherapy","HCHTOG2603","Inclusion Criteria:\n\n1. Age 18-75 years, any sex.\n2. ECOG Performance Status 0-1.\n3. Histologically confirmed, previously untreated thoracic esophageal squamous cell carcinoma (ESCC).\n4. Clinical stage cT2N0M0, T3N0-2M0 (AJCC 8th Edition), assessed as resectable with a potential for R0 resection by endoscopic ultrasound (EUS), PET-CT, and contrast-enhanced CT. Patients with cervical lymph node metastasis may also be included if deemed suitable for three-field lymphadenectomy by a multidisciplinary team assessment.\n5. Adequate bone marrow, hepatic, and renal function:\n\n   * Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, Platelet count ≥ 100 × 10⁹\u002FL, Hemoglobin ≥ 90 g\u002FL.\n   * Alanine aminotransferase \u002F Aspartate aminotransferase ≤ 2.5 × Upper Limit of Normal, Total bilirubin ≤ 1.5 × Upper Limit of Normal.\n   * Serum creatinine ≤ 1.5 × Upper Limit of Normal or Creatinine clearance ≥ 60 mL\u002Fmin.\n6. Signed written informed consent form (ICF).\n\nExclusion Criteria:\n\n1. History of other malignancy within the past 5 years.\n2. Active autoimmune disease.\n3. Active Hepatitis B Virus (HBV) \u002F Hepatitis C Virus (HCV) \u002F Human Immunodeficiency Virus (HIV) infection.\n4. Severe cardiac or pulmonary insufficiency (Left Ventricular Ejection Fraction \\\u003C 50%, Forced Expiratory Volume in 1 second \\\u003C 1 L).\n5. Pregnancy or lactation.",{"count":105,"type":22},1044,[107],"PHASE3","This is a Phase III, multicenter, open-label, randomized controlled trial. The study aims to compare organ preservation versus esophagectomy in patients with locally advanced, resectable thoracic esophageal squamous cell carcinoma (ESCC) who achieve a complete or partial clinical response (cCR\u002FcPR) following neoadjuvant immunochemotherapy.",[110],"Esophageal Squamous Cell Carcinoma",{"date":112,"type":38},"2026-07-31",{"date":114,"type":38},"2026-06-16",{"date":116,"type":22},"2032-03-15",{"name":44,"class":45},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":54,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":68},"100628282","phase-2-efficacy-and-safety-of-lisaftoclax-apg-2575-monotherapy-in-patients-with-mature-b-cell-lymphoma-100628282","NCT07459608","Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphoma","Efficacy and Safety of Lisaftoclax (APG-2575) Monotherapy in Patients With Mature B-cell Lymphomas","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of signing the informed consent form (ICF).\n2. Histologically confirmed diagnosis of an indolent lymphoma (CLL\u002FWM\u002FMZL), meeting one of the following conditions:\n\n   Cohort A: Previously untreated and ineligible for Bruton's Tyrosine Kinase inhibitor (BTKi) therapy due to severe comorbidities (e.g., uncontrolled hypertension, cardiac disease, or active infection, etc.).\n\n   Cohort B: Received only one prior line of BTKi as first-line treatment, did not achieve a partial response (PR), and discontinued BTKi due to intolerable treatment-related adverse events (e.g., atrial fibrillation, hemorrhage, infection, rash, etc.).\n3. Adequate bone marrow function, defined as:\n\n   1. Hemoglobin (Hb) ≥ 70 g\u002FL (without transfusion support within 7 days prior to the first dose of study drug).\n   2. Absolute neutrophil count (ANC) ≥ 0.5 × 10⁹\u002FL (independent of growth factor support within 7 days prior to the first dose of study drug).\n   3. Platelet count ≥ 50 × 10⁹\u002FL (without transfusion support within 7 days prior to the first dose of the study drug. If the patient has documented bone marrow involvement, a platelet count ≥ 30 × 10⁹\u002FL is acceptable, provided the investigator ensures adequate supportive care).\n4. Adequate hepatic and renal function, defined as:\n\n   1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).\n   2. Creatinine clearance (Ccr) ≥ 40 ml\u002Fmin (estimated by the Cockcroft-Gault formula).\n   3. Total bilirubin \\\u003C 1.5 × ULN.\n5. Left ventricular ejection fraction (LVEF) ≥ the lower limit of normal (LLN, 50%).\n6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 3.\n7. Life expectancy ≥ 3 months.\n8. Men, women of childbearing potential (WOCBP, defined as premenopausal women capable of becoming pregnant), and their partners must agree to use highly effective contraception methods (e.g., condoms, implants\u002Finjections\u002Foral contraceptives, intrauterine devices \\[IUD\\], abstinence, or a sterilized partner) during the treatment period and for 90 days after the last dose of the study drug. Postmenopausal women (at least 12 months of spontaneous amenorrhea) or surgically sterile women are not considered WOCBP.\n\nExclusion Criteria:\n\n1. Prior treatment with any B-cell lymphoma 2 (BCL-2) inhibitor.\n2. Patients with active infection (including active hepatitis B virus \\[HBV\\] or hepatitis C virus \\[HCV\\] infection, or human immunodeficiency virus \\[HIV\\] positivity) or any other serious uncontrolled medical condition (Patients who are hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) seropositive are eligible if their HBV DNA is below the lower limit of detection\u002Fquantification and they are willing to undergo monthly HBV reactivation monitoring. Patients who are HCV antibody positive are eligible if their HCV RNA is below the lower limit of detection\u002Fquantification).\n3. Presence of other concurrent malignancies (except for those specified in the inclusion criteria) that may affect the interpretation of study results or treatment with the investigational drug, or patients with severe coagulation disorders, or severe impairment of cardiac, cerebral, pulmonary, hepatic, or renal function.\n4. History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within 12 months prior to the first dose of the study drug.\n5. Administration of any live vaccine within 28 days prior to the first dose of the study drug.\n6. Women of childbearing potential (WOCBP) or men with partners of childbearing potential who are unwilling to use highly effective contraception; pregnant or breastfeeding women.\n7. Inability to swallow tablets, or presence of malabsorption syndrome, any disease significantly affecting gastrointestinal function, gastrectomy\u002Fsmall bowel resection, symptomatic inflammatory bowel disease or ulcerative colitis, or partial\u002Fcomplete bowel obstruction.\n8. Known hypersensitivity to the active pharmaceutical ingredient, excipients of the study drug, or its analogs.\n9. Requirement for concomitant treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A.\n10. Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's judgment, could compromise the patient's safety or pose an undue risk for study participation.",{"count":126,"type":22},75,[56],"This is a multicenter, prospective, single-arm phase II study designed to evaluate the safety and efficacy of lisaftoclax (APG-2575), an oral selective BCL-2 inhibitor, in patients with indolent B-cell lymphomas. The study will enroll adult patients with chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia (WM), or marginal zone lymphoma (MZL) who are either treatment-naïve but considered ineligible for Bruton tyrosine kinase (BTK) inhibitor therapy due to significant comorbidities, or who are intolerant to prior BTK inhibitor treatment.\n\nEligible patients will receive oral lisaftoclax once daily with a dose ramp-up to a target dose of 600 mg in 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment period. The primary objective is to evaluate the safety and tolerability of lisaftoclax monotherapy, while secondary objectives include assessment of antitumor activity, including overall response rate (ORR), complete response (CR) rate, minimal residual disease (MRD) negativity, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Quality of life will also be assessed using the EORTC QLQ-C30 questionnaire.",[130,131,132,133],"Indolent Lymphoma","WM","MZL","CLL \u002F SLL","2026-07-27",{"date":136,"type":38},"2026-07-29",{"date":138,"type":22},"2026-07-10",{"date":140,"type":22},"2028-03-01",{"name":44,"class":45},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":149,"targetDuration":4,"studyType":54,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100635984","phase-2-a-multicenter-open-label-randomized-prospective-clinical-study-of-adebrelimab-consolidation-therapy-for-limited-stage-small-cell-lung-cancer-ls-sclc-without-progression-after-concurrent-chemoradiotherapy-100635984","NCT07559786","A Multicenter, Open-label, Randomized, Prospective Clinical Study of Adebrelimab Consolidation Therapy for Limited-Stage Small-Cell Lung Cancer (LS-SCLC) Without Progression After Concurrent Chemoradiotherapy","ARL-LS-SCLC","Inclusion Criteria:\n\n1.Age ≥ 18 and ≤ 75 years, regardless of gender. 2.Histopathologically confirmed, untreated limited-stage small cell lung cancer (LS-SCLC) (stage I-III per AJCC 8th edition, with all lesions encompassed in a tolerable radiation plan).\n\n3.Clinically staged T1-2N0, operable LS-SCLC patients who are ineligible for surgery or refuse surgery.\n\n4.ECOG performance status 0-1. 5.Expected survival ≥ 3 months. 6.At least one measurable lesion per RECIST 1.1. 7.Pulmonary function: FEV1 \\> 70% of predicted value. 8.Adequate hematologic and end-organ function, with laboratory results obtained within 7 days before first study treatment:\n\n1. Hematology: Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL without G-CSF support within 14 days before first treatment; lymphocyte count (LC) ≥ 0.5×10⁹\u002FL; platelet count (PLT) ≥ 90×10⁹\u002FL without transfusion, G-CSF, or other hematopoietic stimulants within 14 days before first treatment.\n2. Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN (≤3.0 mg\u002FdL for patients with confirmed Gilbert syndrome).\n3. Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault, CKD-EPI, or MDRD equation); urine protein \\\u003C 2+ (if urine protein ≥ 2+, 24-hour urine protein must be \\\u003C 1 g for eligibility).\n4. Coagulation: International normalized ratio (INR) ≤ 1.5; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n5. Echocardiography: Left ventricular ejection fraction (LVEF) ≥ 50%. 9.Sexually active subjects of reproductive potential (non-sterilized) must agree to use at least one medically accepted contraceptive method during study treatment and for 6 months after treatment completion. For females of reproductive potential: serum pregnancy test (HCG) must be negative within 7 days before first dosing.\n\n10.Subjects are voluntarily enrolled, provide written informed consent, have good compliance, and agree to follow-up.\n\nExclusion Criteria:\n\n1. Histologically confirmed combined small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC).\n2. Prior systemic anti-tumor therapy or immune checkpoint inhibitor therapy for SCLC.\n3. Extensive-stage SCLC.\n4. Presence of malignant pleural effusion. If aspiratable pleural effusion is present during screening, at least one thoracentesis must be performed to confirm the presence or absence of malignant cells.\n5. Subjects with known or suspected interstitial lung disease (ILD); other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and severely impair respiratory function, including but not limited to idiopathic pulmonary fibrosis, organizing pneumonia\u002Fbronchiolitis obliterans, etc.\n6. History of active, known or suspected autoimmune disease, including but not limited to myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, etc.\n\n   (Exceptions: Type 1 diabetes mellitus (glycemic control with insulin); residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; conditions not expected to relapse in the absence of external trigger.\n\n   Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo only (excluding psoriatic arthritis) may be enrolled if: rash involves \\\u003C10% of body surface area; disease is well controlled at baseline with only low-potency topical steroids; and no acute exacerbation in the past 12 months (no PUVA, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-potency or oral steroids).)\n7. Concomitant malignancy diagnosed ≤3 years before first study treatment, except adequately treated papillary thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin cancer, locally controlled prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery (hormonal therapy for non-metastatic prostate or breast cancer is allowed).\n8. History of clinically significant cardiovascular disease, including but not limited to:\n\n   Congestive heart failure (NYHA class \\>2); Unstable angina; Myocardial infarction within 3 months before signing ICF; Any severe supraventricular or ventricular arrhythmia requiring treatment or intervention.\n9. Severe infection within 4 weeks before first treatment, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; active infection of CTCAE grade ≥2 requiring systemic antibiotics within 2 weeks before first treatment.\n10. Active tuberculosis within 1 year before enrollment by history or CT scan, or history of active tuberculosis \\>1 year ago without standard treatment.\n11. History of immunodeficiency, including positive HIV serology.\n12. Active hepatitis B or hepatitis C.(HBsAg-positive or HBcAb-positive subjects may be enrolled if HBV DNA \\\u003C upper limit of normal (ULN) of the local laboratory (if no ULN, HBV DNA \\\u003C1000 copies\u002FmL or 500 IU\u002FmL); HCV Ab-positive subjects may be enrolled if HCV RNA \\\u003C ULN of the local laboratory (if no ULN, HCV RNA \\\u003C500 IU\u002FmL).)\n13. Receipt of systemic immunosuppressive therapy within 14 days before first treatment, including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents.\n\n(1)Patients receiving short-term systemic immunosuppression (e.g., corticosteroids for management\u002Fprophylaxis of nausea, vomiting, or hypersensitivity) may be enrolled at the investigator's discretion; a washout period before randomization may be required.\n\n(2)Allowed: inhaled corticosteroids for COPD; mineralocorticoids (e.g., fludrocortisone) for orthostatic hypotension; low-dose corticosteroid replacement (≤10 mg\u002Fday prednisone or equivalent) for adrenal insufficiency.\n\n14.Major surgery within 28 days before first treatment (except diagnostic surgery), or expected major surgery during the study (except diagnostic surgery).\n\n15.Administration of live attenuated vaccine within 28 days before first treatment, or anticipated need during the study (live attenuated influenza vaccine is prohibited within 28 days before first treatment, during treatment, and for 5 months after the last dose of adebrelimab).\n\n16.Prior allogeneic bone marrow transplant or solid organ transplant. 17.History of severe hypersensitivity to monoclonal antibody\u002Ffusion protein drugs.\n\n18.Known psychiatric disorder, alcoholism, drug abuse or substance abuse. 19.Any other condition that, in the investigator's judgment, may prematurely terminate the study, e.g., poor protocol compliance, other severe diseases requiring concurrent treatment, significant laboratory abnormalities, or family\u002Fsocial factors affecting subject safety or data\u002Fsample collection.",{"count":150,"type":22},200,[56],"This study aims to evaluate the efficacy and safety of adebrelimab consolidation therapy after progression-free response of concurrent chemoradiotherapy in patients with limited-stage small cell lung cancer. This study plans to enroll patients with untreated limited-stage small cell lung cancer who meet the inclusion criteria. The eligible patients will be randomly divided 1:1 into two groups to receive treatment regimens for residual lymph nodes and involved irradiated areas. That is, carboplatin AUC 5, D1 + etoposide 100 mg\u002Fm…\\^2 on days 1, 2, and 3 + thoracic radiotherapy (residual lymph nodes or involved irradiated areas), with each 3-week cycle. After 4 cycles of concurrent chemoradiotherapy, the non-progressing subjects will continue to receive adebrelimab (1200 mg, IV, Q3W) maintenance therapy.",[154],"SCLC, Limited Stage","2026-07-17",{"date":157,"type":38},"2026-07-21",{"date":155,"type":22},{"date":160,"type":22},"2029-07-17",{"name":44,"class":45},2,{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":54,"phases":172,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100647465","tolerability-of-dalpiciclib-vs-abemaciclibribociclib-in-early-hrher2--breast-cancer-100647465","NCT07706933","Tolerability of Dalpiciclib vs. Abemaciclib\u002FRibociclib in Early HR+\u002FHER2- Breast Cancer","Tolerability of Dalpiciclib Versus Abemaciclib\u002FRibociclib in Combination With Standard Endocrine Therapy for HR-Positive\u002FHER2-Negative Early Breast Cancer: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥18 years with clinical stage II-III breast cancer at the time of signing informed consent.\n2. Post-operative pathological confirmation of invasive breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), as confirmed by the research center's pathology department:\n\n   * ER positive and\u002For PR positive defined as ≥10% of tumor cells showing positive nuclear staining.\n\n     * HER2 negative defined as immunohistochemistry (IHC) 0 or 1+, or negative by in situ hybridization (ISH).\n3. Pathologically confirmed unilateral primary invasive breast cancer, with the date of breast cancer diagnosis on the pathology report no more than 18 months before randomization. For patients with multicentric or multifocal tumors, all pathologically examined lesions must meet the pathological requirements in criterion .\n4. For patients who received adjuvant chemotherapy: the last chemotherapy dose must be at least 21 days before randomization.\n5. For patients who received adjuvant radiotherapy: the last radiotherapy session must be at least 14 days before randomization.\n6. The last non-endocrine treatment (including surgery, radiotherapy, chemotherapy) must be within 90 days before randomization.\n7. Has undergone curative surgical resection with tumor-free margins on pathological examination, and meets one of the following high-risk categories:\n\n   * Pathologically confirmed tumor involvement in ≥4 ipsilateral axillary lymph nodes; OR ② Pathologically confirmed tumor involvement in 1-3 ipsilateral axillary lymph nodes AND at least one of the following:\n\n     a. Pathological primary invasive tumor size ≥5 cm; b. Primary tumor histological grade 3 (G3); c. Ki-67 ≥20%; d. Known genetic test indicating high risk of recurrence.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n9. No evidence of recurrence or metastatic disease after surgery.\n10. Adequate organ and bone marrow function, meeting the following criteria:\n\n    * White blood cell (WBC) count ≥3,000\u002Fmm³ (3.0 × 10⁹\u002FL) (without G-CSF within 14 days);\n\n      * Absolute neutrophil count (ANC) ≥1,500\u002Fmm³ (1.5 × 10⁹\u002FL) (without G-CSF within 14 days);\n\n        * Platelet count (PLT) ≥100,000\u002Fmm³ (100 × 10⁹\u002FL) (without corrective treatment within 7 days);\n\n          * Hemoglobin (Hb) ≥9 g\u002FdL (90 g\u002FL) (without corrective treatment within 7 days); ⑤ Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥60 mL\u002Fmin (without corrective treatment within 7 days); ⑥ Total bilirubin (TBIL) ≤1.5 × ULN (without corrective treatment within 7 days); ⑦ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN (without corrective treatment within 7 days); ⑧ QTcF ≤470 ms.\n11. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization, and must agree to use acceptable non-hormonal contraception from the signing of informed consent until 7 months after the last dose of dalpiciclib, or 21 days after the last dose of abemaciclib\u002Fribociclib, or 2 months after the last dose of aromatase inhibitor or tamoxifen\u002Ftoremifene (whichever is longer).\n12. All toxicities from prior anti-cancer therapy must have recovered to grade 0-1 (CTCAE version 6.0), except for those explicitly stated in the inclusion\u002Fexclusion criteria.\n13. Has voluntarily signed the informed consent form, and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of HER2-positive breast cancer (HER2-positive defined as immunohistochemistry \\[IHC\\] 3+ or positive by in situ hybridization \\[ISH\\]).\n2. Local or regional recurrence of breast malignancy.\n3. Clinical stage IV (metastatic) breast cancer.\n4. Bilateral breast cancer (including contralateral carcinoma in situ).\n5. History of any malignancy other than breast cancer within 5 years before randomization, excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.\n6. History of severe pulmonary disease such as interstitial pneumonia.\n7. Prior treatment with any CDK4\u002F6 inhibitor, other anti-cancer biologic therapy, targeted therapy, or cancer immunotherapy.\n8. Concurrent participation in another clinical trial of anti-cancer therapy (including endocrine therapy or immunotherapy).\n9. Major surgical procedure, receipt of any investigational drug, other anti-cancer treatment, or use of immunomodulators within 4 weeks before randomization (excluding chemotherapy, radiotherapy, and endocrine therapy for breast cancer).\n10. Known infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA ≥500 IU\u002FmL); hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and hepatitis C.\n11. Any of the following within 6 months before randomization: myocardial infarction, severe\u002Funstable angina pectoris, New York Heart Association (NYHA) class ≥2 heart failure, persistent arrhythmia of grade ≥2 (according to NCI CTCAE version 6.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism.\n12. Severe infection within 4 weeks before randomization (e.g., requiring intravenous antibiotics, antifungals, or antivirals per clinical practice guidelines), or unexplained fever \\>38.5°C during screening or before the first dose.\n13. Inability to swallow, intestinal obstruction, or other factors affecting drug administration or absorption.\n14. Known hypersensitivity to aromatase inhibitors, tamoxifen-class drugs (e.g., tamoxifen, toremifene), and LHRH agonists; known hypersensitivity to dalpiciclib\u002Fabemaciclib\u002Fribociclib or any of their excipients\n15. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n16. Known history of substance abuse (including psychoactive drugs).\n17. Women within 1 year postpartum or currently breastfeeding.\n18. Presence of any other serious physical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for the study in the opinion of the investigator.",{"count":171,"type":22},456,[173],"NA","In recent years, the successful application of cyclin-dependent kinase 4\u002F6 inhibitors (CDK4\u002F6i) has transformed the treatment landscape for HR+\u002FHER2- advanced breast cancer and driven research into their use in adjuvant settings. Large Phase III trials including MONARCH-E and NATALEE have demonstrated that combining CDK4\u002F6i with standard endocrine therapy significantly reduces the risk of recurrence or death in high-risk patients with early breast cancer. This regimen has been recommended by leading domestic and international clinical guidelines. Nevertheless, patients' quality of life, symptom burden and treatment adherence are also critical in clinical practice. Patient-reported outcomes (PROs), especially electronic PROs (ePROs), can effectively complement conventional study endpoints and provide important evidence for the comprehensive evaluation of long-term treatment.\n\nThis is a prospective, multicenter, randomized controlled clinical trial. The primary objective is to compare the tolerability of dalpiciclib versus abemaciclib\u002Fribociclib, each combined with standard endocrine therapy, in the adjuvant treatment of patients with high-risk HR+\u002FHER2- early breast cancer. Eligible patients who have received curative local therapy will be randomized to either the experimental group (dalpiciclib plus endocrine therapy) or the control group (ribociclib\u002Fabemaciclib plus endocrine therapy). Stratified block randomization will be applied, with stratification factors including menopausal status and prior history of neoadjuvant\u002Fadjuvant chemotherapy.\n\nThe total duration of endocrine therapy is 5 years. The treatment duration of CDK4\u002F6i is approximately 104 weeks for dalpiciclib, 156 weeks for ribociclib, and 104 weeks for abemaciclib. CDK4\u002F6i will be discontinued in cases of disease recurrence, intolerable toxicity, patient withdrawal, or discontinuation as determined by the investigator. Patients will be regularly asked to complete ePRO questionnaires throughout the treatment period.",[176],"Breast Cancer",[178,179,180,181],"HR+","early breast cancer","Dalpiciclib","ePRO","2026-07-11",{"date":184,"type":38},"2026-07-16",{"date":186,"type":22},"2026-08-01",{"date":188,"type":22},"2033-06-30",{"name":44,"class":45},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":54,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":209,"leadSponsor":211,"locationsCount":4},"100645984","phase-2-toripalimab-combined-with-beat-chemotherapy-in-the-treatment-of-advanced-back-line-small-cell-lung-cancer-100645984","NCT07698054","Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer","A Prospective, Open-label, Bayesian Adaptive Randomized Phase II Clinical Study of Toripalimab Combined With Beat Chemotherapy in the Treatment of Advanced Back-line Small Cell Lung Cancer","Inclusion Criteria:\n\n* 1.Age ≥18 years old, both male and female are acceptable.\n* 2\\. Histology and pathology diagnosis of extensive stage small cell lung cancer, and must meet the following standards:\n\n  1. always has not received the immune therapy,\n  2. Previously received immunotherapy, with the number of treatment lines ≥2 and the immunotherapy being effective(immunotherapy PFS \\> 3 months, withdrawal time \\> 3 months)\n  3. never used anlotinib,\n* 3\\. ECOG: 0 \\~ 2;\n* 4 . The expected lifetime 12 weeks or more;\n* 5\\. Major organs function normal\n\nExclusion Criteria:\n\n* 1.Those who are allergic to toripalimab or etoposide or have metabolic disorders;\n* 2.With known the special ripley sheet resistance, etoposide contraindication;\n* 3.Other circumstances that the researcher assessed as unsuitable for participation in this clinical study.",{"count":198,"type":22},130,[56],"This study is a randomized, open-label, multi-center investigator-initiated clinical trial. Patients who meet the inclusion criteria receive the treatment plan stipulated in the protocol. A Bayesian design is used to explore the efficacy and safety of teprotumumab combined with pulse chemotherapy in the treatment of advanced second-line extensive-stage small cell lung cancer.",[202,203,204],"SCLC, Extensive Stage","Bayesian","Metronomic Chemotherapy","2026-07-09",{"date":207,"type":38},"2026-07-13",{"date":186,"type":22},{"date":210,"type":22},"2030-12-31",{"name":44,"class":45},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":54,"phases":221,"briefSummary":223,"conditions":224,"keywords":226,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":4},"100645689","phase-1-safety-and-efficacy-of-intrathecal-sacituzumab-tirumotecan-for-leptomeningeal-metastasis-in-egfr-tki-resistant-non-small-cell-lung-cancer-100645689","NCT07702305","Safety and Efficacy of Intrathecal Sacituzumab Tirumotecan for Leptomeningeal Metastasis in EGFR-TKI-Resistant Non-Small Cell Lung Cancer","Safety and Efficacy of Intrathecal Injection of Sacituzumab Tirumotecan (SKB264) in the Treatment of Leptomeningeal Metastasis From EGFR-TKI-Resistant Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nAge ≥ 18 years;\n\nPathologically diagnosed as EGFR mutation-positive non-small cell lung cancer;\n\nLeptomeningeal metastasis confirmed by detection of tumor cells in cerebrospinal fluid cytology;\n\nPreviously received targeted therapy against EGFR mutation and progressed;\n\nECOG performance status ≤ 3;\n\nNeurological symptoms stable for more than 7 days (defined as no new or worsening neurological symptoms and no more than a 1-point change in ECOG score);\n\nIf radiotherapy (including whole-brain radiotherapy, stereotactic radiotherapy, etc.) has been received, at least 7 days after completion; if other intrathecal therapy has been received, a washout period of at least 7 days;\n\nAbsolute neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 80 g\u002FL, platelet count ≥ 75 × 10⁹\u002FL;\n\nProthrombin time\u002Finternational normalized ratio and partial thromboplastin time ≤ 1.5 × upper limit of normal;\n\nTotal bilirubin ≤ 1.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (elevations of total bilirubin and transaminases caused by tumor may be relaxed to 3× and 5×, respectively), creatinine ≤ 2 × upper limit of normal; calculated creatinine clearance ≥ 50 mL\u002Fmin.\n\nExclusion Criteria:\n\nActive infectious disease within 7 days before the start of study drug treatment;\n\nECOG performance status ≥ 4;\n\nHistory of allergy to any component of the study drug;\n\nHistory of severe hypersensitivity reaction to any monoclonal antibody;\n\nPatients currently participating in other interventional studies;\n\nPrevious or current severe immunodeficiency disease;\n\nAny other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.",{"count":220,"type":22},15,[222],"PHASE1","This study is a Phase I, single-arm, single-center, dose-escalation clinical trial designed to investigate the safety and efficacy of intrathecal injection of sacituzumab tirumotecan (sac-TMT) in patients with EGFR mutation-positive non-small cell lung cancer and leptomeningeal metastasis who have progressed after prior EGFR-TKI therapy, and to determine the optimal dose (RP2D). The study employs an \"accelerated titration\" combined with a \"3+3\" dose-escalation design, with a starting dose of 0.05 mg\u002Fkg, sequentially escalating to 0.5 mg\u002Fkg. The drug is administered via intrathecal injection through an Ommaya reservoir once every 14 days, along with concomitant intrathecal injection of dexamethasone 5 mg to prevent chemical meningitis. The primary endpoints are safety (incidence, severity, and grading of adverse events and serious adverse events) and the recommended dose (RP2D). Secondary endpoints include intracranial objective response rate, time to treatment failure, progression-free survival, and overall survival. The study plans to enroll 8-15 subjects. Efficacy assessment is based on evaluation of neurological symptoms, cerebrospinal fluid cytology, and neuroimaging changes. Special attention is given to adverse events of special interest, including neurotoxicity and bone marrow suppression. This study aims to provide a new treatment strategy for patients with leptomeningeal metastasis after EGFR-TKI resistance and to generate pioneering data for the intrathecal administration of ADC drugs.",[225],"EGFR-TKI-resistant Non-small Cell Lung Cancer With Leptomeningeal Metastasis",[227,228,229,230,231],"Sacituzumab tirumotecan","Intrathecal injection","EGFR-TKI-resistant","NSCLC","Leptomeningeal metastasis",{"date":233,"type":38},"2026-07-14",{"date":235,"type":22},"2026-06-23",{"date":237,"type":22},"2027-12-31",{"name":44,"class":45},{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":246,"targetDuration":4,"studyType":54,"phases":248,"briefSummary":249,"conditions":250,"keywords":252,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":68},"100646903","phase-2-lisaftoclax-plus-pirtobrutinib-in-relapsed-or-refractory-mantle-cell-lymphoma-after-btk-targeted-therapy-100646903","NCT07684950","Lisaftoclax Plus Pirtobrutinib in Relapsed or Refractory Mantle Cell Lymphoma After BTK-Targeted Therapy","A Prospective Phase 2 Study of Lisaftoclax Plus Pirtobrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma After Failure of BTK-Targeted Therapy","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Age 18 years or older.\n  2. Histologically and immunophenotypically confirmed mantle cell lymphoma.\n  3. At least one measurable lesion.\n  4. Received at least one prior systemic treatment regimen that included a BTK-targeted therapy, including a covalent BTK inhibitor, non-covalent BTK inhibitor, or BTK degrader, and had stable disease, disease progression, or intolerance during or after the most recent BTK-targeted therapy.\n  5. Eastern Cooperative Oncology Group performance status of 0 to 2.\n  6. Adequate hepatic, renal, and bone marrow function, defined as all of the following:\n\n     \\* Aspartate aminotransferase and alanine aminotransferase ≤3 × upper limit of normal;\n     * Total bilirubin ≤1.5 × upper limit of normal;\n     * Creatinine clearance ≥30 mL\u002Fmin;\n     * Absolute neutrophil count ≥0.5 × 10\\^9\u002FL;\n     * Platelet count ≥30 × 10\\^9\u002FL. Supportive treatment is permitted.\n  7. Participants of reproductive potential must agree to use effective contraception during study treatment and for 3 months after the last dose of study treatment.\n  8. Willing and able to comply with study procedures and follow-up assessments.\n  9. Able to understand and voluntarily sign the informed consent form before screening.\n\nExclusion Criteria:\n\n* 1\\. Known hypersensitivity to pirtobrutinib, lisaftoclax, or any component or excipient of either study drug.\n\n  2\\. Concurrent participation in another clinical study. 3. Prior treatment with any BCL-2 inhibitor. 4. Active central nervous system involvement, including parenchymal or leptomeningeal disease.\n\n  5\\. Clinically significant uncontrolled cardiac or cardiovascular disease, or a history of myocardial infarction within 6 months before the planned initiation of pirtobrutinib.\n\n  6\\. Uncontrolled active severe systemic bacterial, viral, fungal, or parasitic infection.\n\n  7\\. Current treatment with strong CYP3A4 inhibitors or inducers and\u002For strong P-glycoprotein inhibitors.\n\n  8\\. Positive human immunodeficiency virus test. 9. Active hepatitis B or hepatitis C infection, except:\n  * Participants with detectable hepatitis B virus DNA whose disease is controlled may be enrolled at the investigator's discretion, provided that concurrent antiviral therapy is administered;\n  * Participants with a history of hepatitis C virus infection who have completed antiviral treatment and have a viral load below the lower limit of quantification may be enrolled.\n\n    10\\. Pregnant or breastfeeding women. 11. Unable to complete protocol-required study visits or procedures, including follow-up visits, or unable to comply with study requirements.\n\n    12\\. Any other clinically significant current or prior medical condition that, in the investigator's judgment, may pose a risk to participant safety or interfere with study assessments, procedures, or completion.",{"count":247,"type":22},45,[56],"This prospective, open-label, phase 2 study will evaluate the efficacy and safety of lisaftoclax in combination with pirtobrutinib in adults with relapsed or refractory mantle cell lymphoma following failure of prior BTK-targeted therapy.\n\nThe study includes two cohorts. Cohort 1 will enroll participants who experienced stable disease, disease progression, or intolerance following treatment with a covalent BTK inhibitor. Cohort 2 is an exploratory cohort enrolling participants who experienced stable disease, disease progression, or intolerance following treatment with a non-covalent BTK inhibitor other than pirtobrutinib or a BTK degrader.\n\nParticipants will receive oral pirtobrutinib 200 mg once daily in combination with oral lisaftoclax. Lisaftoclax will be administered using a dose ramp-up schedule, followed by a target dose of 600 mg once daily. Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent.",[251],"Mantle Cell Lymphoma (MCL)",[253,254,255,256,257,258,259],"Relapsed Mantle Cell Lymphoma","Refractory Mantle Cell Lymphoma","BTK Inhibitor","BCL-2 Inhibitor","Non-Covalent BTK Inhibitor","Lisaftoclax","Pirtobrutinib","2026-06-29",{"date":262,"type":38},"2026-07-06",{"date":264,"type":22},"2026-06-30",{"date":266,"type":22},"2029-04-30",{"name":44,"class":45},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":274,"enrollmentInfo":275,"targetDuration":4,"studyType":54,"phases":277,"briefSummary":278,"conditions":279,"keywords":281,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":289,"locationsCount":4},"100638921","a-multicenter-randomized-open-label-controlled-study-of-haic-combined-with-camrelizumab-and-apatinib-mesylate-for-perioperative-treatment-of-resectable-hepatocellular-carcinoma-with-high-risk-recurrence-factors-100638921","NCT07618546","A Multicenter, Randomized, Open-label, Controlled Study of HAIC Combined With Camrelizumab and Apatinib Mesylate for Perioperative Treatment of Resectable Hepatocellular Carcinoma With High-risk Recurrence Factors","Inclusion Criteria:\n\n* 1: 1. Age 18-80, both male and female are acceptable;\n\n  2: 2. Hepatocellular carcinoma (HCC) confirmed by histopathology, cytology, or imaging, with CNLC staging of Ia-IIIa, excluding patients with stage IIIa HCC combined with main portal vein tumor thrombus;\n\n  3: 3. Meets the indications for radical surgical resection;\n\n  4: 4. There are clearly defined high-risk recurrence factors (tumor diameter \\>5 cm, microvascular invasion, satellite lesions, incomplete tumor capsule, alpha-fetoprotein \\>400 μg\u002FL, etc.;\n\n  5: 5. ECOG: 0-1;\n\n  6: 6. The functions of major organs have been assessed and meet the requirements for the study treatment;\n\n  7: 7. Has not previously received systematic treatment.\n\n  8: 8. Expected survival time ≥ 12 weeks;\n\n  9: 9. Baseline blood cell count tests and blood biochemistry must meet the following criteria: white blood cell count ≥ 3.0 × 10\\^9\u002FL; hemoglobin ≥ 90 g\u002FL; absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL; platelet count ≥ 75 × 10\\^9\u002FL; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN); total bilirubin ≤ 2 times ULN; serum creatinine ≤ 1.5 times ULN; albumin ≥ 30 g\u002FL;\n\n  10: 10. Women of childbearing age must agree to use contraception (such as intrauterine devices, contraceptive pills, or condoms) during the study period and for 6 months after the end of the study; they must have a negative serum or urine pregnancy test within 7 days prior to enrollment in the study and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the study ends.\n\n  11: 11. The subjects voluntarily joined this study, signed the informed consent form, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* 1: 1. Merge distant metastases;\n\n  2: 2. Those allergic to camrelizumab and apatinib mesylate;\n\n  3: 3. Previously received systemic or local treatment for liver cancer;\n\n  4: 4. Pleural effusion, pericardial effusion, or ascites accompanied by clinical symptoms and judged by the investigator to require frequent drainage;\n\n  5: 5. History of organ transplantation (including autologous bone marrow transplantation and peripheral stem cell transplantation);\n\n  6: 6. Active or uncontrolled serious infections (≥CTCAE5.0 grade 2 infection), including but not limited to hospitalization due to infectious complications, bacteremia, or severe pneumonia, and unexplained fever \\>38.5°C before the first dose;\n\n  7: 7. Those with a history of abuse of psychotropic drugs who are unable to quit, or who have mental disorders;\n\n  8: 8.5 Subjects who have had or currently have other malignant tumors requiring active treatment (excluding those that have been adequately treated, such as basal cell or squamous cell skin cancer with an expected 5-year survival rate \\>90%, carcinoma in situ of the cervix, or carcinoma in situ of the breast);\n\n  9: 9. Presence of uncorrectable coagulation disorders;\n\n  10: 10. Cardiovascular diseases with significant clinical relevance, including but not limited to acute myocardial infarction, severe\u002Funstable angina, or coronary artery bypass surgery within 6 months prior to enrollment; congestive heart failure New York Heart Association (NYHA) class ≥ 2; ventricular arrhythmias requiring medication (including QTc interval ≥ 450 ms for males, ≥ 470 ms for females); left ventricular ejection fraction (LVEF) \\\u003C50%;\n\n  11: 11. Severe liver disease (such as cirrhosis), kidney disease, respiratory system diseases, uncontrolled diabetes, or other types of systemic diseases.\n\n  12: 12. Imaging shows that the tumor has invaded major blood vessels, or the researcher judges that during subsequent studies, the tumor is highly likely to invade major blood vessels and cause fatal massive bleeding;\n\n  13: 13. Patients with active autoimmune diseases or immunodeficiency, or with the following medical history, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, rheumatoid arthritis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, etc., shall not be included. Exceptions are as follows: patients with a history of autoimmune hypothyroidism who are receiving thyroid hormone replacement therapy may be eligible for the study. Patients with type 1 diabetes whose blood glucose is controlled after insulin therapy may participate in this study.\n\n  14: 14. The patient is using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10mg\u002Fday of prednisone or other equivalent steroids, and still using within 2 weeks prior to enrollment);\n\n  15: 15. Experienced arterial\u002Fvenous thrombotic events within 6 months before the first administration, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral embolism, etc.), deep vein thrombosis, and pulmonary embolism;\n\n  16: 16. The investigator assesses digestive tract diseases or conditions that may affect drug absorption, including but not limited to active gastric and duodenal ulcers, ulcerative colitis, or incompletely resected gastrointestinal tumors with active bleeding, or other conditions deemed by the investigator that may cause gastrointestinal bleeding or perforation, and those with multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction).\n\n  17: 17. Hypertension not adequately controlled by medication is defined as: systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>100 mmHg;\n\n  18: 18. Underwent surgery (excluding biopsy) within 28 days before being enrolled in this study, or the surgical incision has not completely healed;\n\n  19: 19. Received any other investigational drug treatment or participated in other interventional studies within 4 weeks prior to signing the informed consent form;\n\n  20: 20. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n\n  21: 21. According to the researcher's judgment, the patient is considered not suitable for enrollment.","80 Years",{"count":276,"type":22},208,[173],"This study aims to explore the value of the 'HAIC Apatinib Camrelizumab' triple regimen for perioperative treatment of resectable hepatocellular carcinoma. The study adopts a multicenter, randomized, open-label, controlled design and plans to enroll 208 patients, randomly assigned 1:1 to the experimental group and the control group. The experimental group will receive preoperative HAIC combined with targeted-immunotherapy triple regimen neoadjuvant therapy, followed by radical resection, and continue postoperative adjuvant therapy; the control group will undergo surgery directly. The primary endpoint is EFS, and secondary endpoints include R0 resection rate, pCR, MPR, OS, and 1-year\u002F2-year\u002F3-year EFS rates.",[280],"HCC - Hepatocellular Carcinoma",[282],"HCC","2026-05-25",{"date":285,"type":38},"2026-06-01",{"date":283,"type":22},{"date":288,"type":22},"2028-03-31",{"name":44,"class":45},{"id":291,"slug":292,"hasResults":12,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":54,"phases":300,"briefSummary":301,"conditions":302,"keywords":304,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":68},"100638229","phase-2-retlirafusp-alfa-combined-with-apatinib-and-nab-paclitaxel-as-second-line-treatment-for-gastric-or-gastroesophageal-junction-cancer-100638229","NCT07610629","Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Gastric or Gastroesophageal Junction Cancer","Retlirafusp Alfa Combined With Apatinib and Nab-Paclitaxel as Second-line Treatment for Patients With Immunotherapy-Pretreated Gastric or Gastroesophageal Junction Cancer: A Prospective, Single-Arm Clinical Study","RA-A-NP","Inclusion Criteria:\n\n1. Able to provide written informed consent prior to any study-specific procedures\n2. Age ≥ 18 years\n3. ECOG performance status 0 or 1\n4. Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced unresectable, locally recurrent, or metastatic\n5. Human epidermal growth factor receptor 2 (HER2) negative\n6. Failed first-line immunotherapy-containing systemic treatment\n7. At least one measurable lesion per RECIST Version 1.1\n8. Adequate organ function:\n\n1)Hemoglobin ≥ 90 g\u002FL 2)Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL 3)Platelet count ≥ 80 × 10⁹\u002FL 4)Total bilirubin \\\u003C 1.5 × upper limit of normal (ULN) 5)ALT\u002FAST \\\u003C 2.5 × ULN; \\\u003C 5 × ULN in patients with liver metastasis 6)Serum creatinine ≤ 1.5 × ULN or creatinine clearance \\> 60 mL\u002Fmin 7)Urine protein \\\u003C 2+ or 24-hour urine protein \\\u003C 1 g 8)Left ventricular ejection fraction (LVEF) ≥ 50% 9)Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN 8.Fertile male and female subjects must agree to use highly effective contraception during the study and for 6 months after the last dose of study treatment; female subjects must have a negative pregnancy test within 7 days before enrollment\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the study drugs\n2. Prior treatment with any VEGFR inhibitor (including apatinib, sorafenib, sunitinib)\n3. Prior treatment with retlirafusp alf\n4. Received any investigational drug within 4 weeks before first dose\n5. Received systemic corticosteroid (\\> 10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks before first dose, except for allowed topical\u002Finhaled use or physiological replacement\n6. Active autoimmune disease or history of autoimmune disease (except controlled hypothyroidism, type 1 diabetes with stable insulin, vitiligo, resolved childhood asthma)\n7. Known immunodeficiency (including HIV infection), organ transplantation, or allogeneic hematopoietic stem cell transplantation\n8. Uncontrolled cardiac disease: NYHA Class ≥ II heart failure, unstable angina, myocardial infarction within 1 year, clinically significant arrhythmia requiring intervention\n9. Severe infection (CTCAE Grade \\> 2) within 4 weeks before first dose; active pulmonary infection, interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis; active tuberculosis\n10. Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL) or active hepatitis C (HCV RNA positive)\n11. History of other malignancy within 5 years before enrollment, except adequately treated basal cell carcinoma, squamous cell carcinoma of skin, or carcinoma in situ of cervix\n12. Pregnant or lactating women\n13. Unwilling or unable to comply with study procedures\n14. Any other condition deemed inappropriate by the investigator",{"count":299,"type":22},50,[56],"This is a prospective, single-arm, investigator-initiated phase II clinical study. The study evaluates the efficacy and safety of retlirafusp alfa (a PD-L1\u002FTGF-βRII bifunctional fusion protein) combined with apatinib (a VEGFR-2 tyrosine kinase inhibitor) and nab-paclitaxel in patients with locally advanced unresectable, locally recurrent, or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma who have progressed after first-line immunotherapy-containing treatment.",[303],"Gastric Adenocarcinoma",[305,306],"Immunotherapy-Pretreated Gastric Cancer","retlirafusp alfa",{"date":308,"type":38},"2026-05-28",{"date":310,"type":22},"2026-05-05",{"date":312,"type":22},"2029-06-30",{"name":44,"class":45},{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":4,"eligibilityCriteria":320,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":54,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":333,"locationsCount":68},"100635931","phase-1-exploration-of-the-application-of-methotrexate-loaded-drug-vesicles-in-intrathecal-injection-for-meningeal-metastasis-of-lung-cancer-100635931","NCT07559097","Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer","A Phase I\u002FII, Single-arm, Single-center Clinical Study: Exploration of the Application of Methotrexate-loaded Drug Vesicles in Intrathecal Injection for Meningeal Metastasis of Lung Cancer","Inclusion Criteria:\n\n\\-\n\nParticipants can be enrolled in this study only if they meet all of the following inclusion criteria:\n\n1. Age ≥ 18 years old;\n2. Diagnosed with lung cancer by pathological biopsy or cytology;\n3. Diagnosed with meningeal metastasis by detecting tumor cells in cerebrospinal fluid cytology;\n4. Patients with advanced lung cancer and meningeal metastasis who have failed standard treatment;\n5. ECOG PS 0 - 3.\n\nExclusion Criteria:\n\n\\-\n\nThe following conditions will disqualify a patient from participating in this study:\n\n1. Concurrent central nervous system infectious diseases;\n2. ECOG PS ≥ 4;\n3. Patients currently participating in other interventional studies;\n4. History of or current severe immunodeficiency diseases;\n5. Any other conditions that, in the judgment of the researcher, make the patient unfit to participate in this study.",{"count":322,"type":22},14,[222,56],"This is a phase I\u002FII, single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, and preliminary efficacy of intrathecal injection of methotrexate-loaded autologous tumor cell-derived microparticles (MTX-MPs) in patients with leptomeningeal metastasis from lung cancer who have failed standard of care.\n\nThe study consists of two phases: Phase I employs an accelerated titration combined with a \"3+3\" dose-escalation design to determine the maximum tolerated dose (MTD) and the recommended phase II dose (RP2D). Phase II further assesses the objective response rate (ORR) at the RP2D. Key secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profile.\n\nApproximately 10-20 patients with cytologically confirmed leptomeningeal metastasis (age ≥18 years, ECOG PS 0-3) will be enrolled. Participants will receive intrathecal MTX-MPs on days 1, 3, and 5 of the first cycle, followed by once every 3 weeks (Q3W) until disease progression, unacceptable toxicity, or death.\n\nTumor response will be evaluated using the Response Assessment in Neuro-Oncology (RANO) criteria for leptomeningeal metastasis, and adverse events will be graded according to CTCAE version 5.0. This exploratory study may provide a novel local therapeutic approach for leptomeningeal metastasis from lung cancer.",[326],"Leptomeningeal Metastasis From Lung Cancer","2026-04-24",{"date":329,"type":38},"2026-04-30",{"date":331,"type":38},"2025-09-08",{"date":237,"type":22},{"name":44,"class":45},{"id":335,"slug":336,"hasResults":12,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":54,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":68},"100634503","phase-2-a-multicohort-study-of-toripalimab-in-combination-with-investigator-selected-chemotherapy-for-advanced-her2-negative-breast-cancer-100634503","NCT07540533","A Multicohort Study of Toripalimab in Combination With Investigator-Selected Chemotherapy for Advanced HER2-Negative Breast Cancer","2025-370","Inclusion Criteria:\n\n1. Voluntary participation: the subject must give written informed consent, be compliant, and agree to attend all follow-up visits.\n2. Age ≥ 18 years.\n3. ECOG performance-status score ≤ 1 and life expectancy ≥ 3 months.\n4. Histologically or cytologically confirmed HER2-negative breast cancer (HER2-negative is defined as either IHC 0, IHC 1+, or IHC 2+ with a negative in-situ-hybridisation \\[ISH\\] result).\n5. For subjects with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC):\n\n   \\- Must have experienced progression during\u002Fafter at least one prior systemic regimen for recurrent\u002Fmetastatic disease (recurrence ≤ 12 months after neoadjuvant\u002Fadjuvant therapy counts as first-line failure).\n\n   \\- Cohort assignment by prior immune-checkpoint-inhibitor (ICI) exposure:\n   1. Cohort A - ICI-pretreated:\n\n      * If ICI was given in adjuvant setting, recurrence must occur ≥ 12 months after completion of immunotherapy.\n      * If ICI was given in neoadjuvant or metastatic setting, best overall response must have met clinical-benefit criteria (PR, CR, or SD \\> 24 weeks).\n   2. Cohort B - ICI-naïve: no prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any other antibody targeting T-cell co-stimulatory or checkpoint pathways.\n6. For subjects with hormone-receptor-positive (HR+) breast cancer:\n\n   * Must have progressed after ≥ 2 prior endocrine regimens in the recurrent\u002Fmetastatic setting (unless investigator judges no endocrine benefit), and\n   * Must have progressed after ≥ 1 prior systemic chemotherapy for recurrent\u002Fmetastatic disease (recurrence ≤ 12 months after adjuvant\u002Fneoadjuvant therapy counts as first-line failure).\n7. At least one measurable lesion per RECIST v1.1.\n8. Adequate organ function, defined as:\n\n   Haematology (no transfusion within 14 days):\n   1. Haemoglobin ≥ 9 g\u002FdL\n   2. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL\n   3. Platelet count ≥ 100 × 10⁹\u002FL . Serum chemistry:\n\n   \u003C!-- -->\n\n   1. Total bilirubin ≤ 1.5 × ULN, or if total bilirubin \\> ULN then direct bilirubin ≤ ULN\n   2. ALT and AST ≤ 2.5 × ULN\n   3. Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin\n9. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days before first dose and must use highly effective contraception from first dose until 6 months after last dose.\n\nWOCBP is defined as any sexually mature female who has not undergone hysterectomy or bilateral oophorectomy and who has not experienced natural amenorrhoea for ≥ 24 consecutive months (including women with treatment-induced amenorrhoea).Men whose partners are WOCBP must also use effective contraception during the same period.\n\nExclusion Criteria:\n\n1. Uncontrolled central-nervous-system metastases (symptomatic or requiring corticosteroids or mannitol for symptom control).\n2. Clinically significant or uncontrolled cardiac disease within 6 months before first dose, including congestive heart failure, angina, myocardial infarction, or ventricular arrhythmia.\n3. Malignancy within 5 years before first dose, except adequately treated basal-cell carcinoma of the skin or carcinoma in situ of the cervix.\n4. Active autoimmune disease requiring systemic therapy within 2 years before first dose, except vitiligo, type-1 diabetes, or residual hypothyroidism due to autoimmune thyroiditis managed with hormone replacement only.\n5. Uncontrolled pleural, pericardial, or ascitic fluid requiring repeated drainage.\n6. Documented human immunodeficiency virus (HIV) infection.\n7. Documented hepatitis-B infection or active hepatitis-C infection.\n8. Prior hypersensitivity to any component or excipient of the investigational product(s).\n9. Any condition judged by the investigator to render the patient unsuitable for trial participation.",{"count":342,"type":22},92,[56],"To evaluate the efficacy and safety of toripalimab in combination with investigator-selected chemotherapy in patients with recurrent or metastatic HER2-negative breast cancer who have failed prior systemic therapy.",[346],"Advanced Breast Cancer","2026-04-14",{"date":349,"type":38},"2026-04-20",{"date":351,"type":38},"2026-01-20",{"date":353,"type":22},"2028-08",{"name":44,"class":45},{"id":356,"slug":357,"hasResults":12,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":362,"minAge":19,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":54,"phases":366,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":68},"100469903","phase-2-utidelone-combined-with-bevacizumab-in-the-treatment-of--2-lines-of-her-2-negative-advanced-breast-cancer-100469903","NCT05398861","Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer","A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. Signed Informed Consent Form;\n2. Women aged 18-70 years;\n3. The number of treatment lines for patients ≥ 2 lines；\n4. Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:\n5. Patients with HER2-negative breast cancer who have failed previous treatment with taxanes and\u002For anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who have progressed after at least one line of previous endocrine drug therapy;\n6. Eastern Cooperative Oncology Group (ECOG) score \\[0-2\\] points，Life expectancy of not less than 3 months；\n7. At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1)；\n8. Adequate hematological, hepatic and renal function；\n9. Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior anticancer therapy；\n10. Women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after administration of the study drug; Subjects must be non-lactating and have a negative serum or urine pregnancy test within 7 days prior to study enrollment\n\nExclusion Criteria:\n\n1. Patients who have progressed on prior bevacizumab；\n2. Patients who have previously used Utidelone, and the interval is less than 6 months from the end of medication；\n3. Less than 3 weeks after radiotherapy or chemotherapy; less than 1 week after endocrine therapy；\n4. Concomitant diseases\u002Fmedical history； （1）Clinically significant hemoptysis (with daily hemoptysis of more than 50 ml) within 3 months before enrollment; or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood or greater at baseline, or suffering from vasculitis； （2）Patients with arteriovenous thrombotic events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (except resolved venous thrombosis caused by previous chemotherapy, which has been judged by the investigator) and pulmonary embolism； （3）Hypertension not adequately controlled with antihypertensive therapy (systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg); Randomization occurs within 6 months as follows: myocardial infarction, severe\u002Funstable angina, NYHA Class 2 or greater, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure （4）Interstitial lung disease, pneumonitis, or uncontrollable systemic disease (e.g., diabetes, pulmonary fibrosis, acute pneumonitis, etc.； （5）Renal insufficiency: urine routine showed urine protein ≥ + +, or 24 h urine protein ≥ 1.0g was confirmed； （6）History of attenuated live vaccine within 28 days before the first dose of study drug or anticipated vaccination with live attenuated vaccines during the study （7）Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU\u002Fml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C； （8）Presence of severe infection within 4 weeks before administration, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infection with CTCAE 5.0 ≥ grade 2 requiring systemic antibiotic therapy within 2 weeks before the first dose, or unexplained fever \\> 38.5 ° C during the screening period\u002Fbefore the first dose (fever due to tumor causes may be included if judged by the investigator); evidence of active tuberculosis infection within 1 year before dosing.\n5. Any other malignancy diagnosed within 3 years before study entry；\n6. Major surgery within 28 days and minor surgery within 14 days before enrollment；\n7. Patients who have previously received or are ready to receive allogeneic bone marrow transplantation or solid organ transplantation；\n8. Peripheral neuropathy ≥ grade 2; active brain metastases, carcinomatous meningitis, spinal cord compression, or brain or leptomeningeal disease found by CT or MRI at screening (patients with brain metastases who have completed treatment on 14 days before enrollment and have stable symptoms, however, it needs to be confirmed as no cerebral hemorrhage symptoms by brain MRI, CT or venography evaluation);\n9. Female patients who are pregnant, lactating, or plan to become pregnant during the study;\n10. Patients who have other serious physical or mental illness or abnormal laboratory findings that may increase the risk of study participation, or interfere with study results, and are not suitable for this study in the opinion of the investigator;","FEMALE","70 Years",{"count":365,"type":22},79,[56],"This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.",[369],"HER-2 Negative Breast Cancer","2026-04-13",{"date":372,"type":38},"2026-04-16",{"date":374,"type":38},"2022-08-19",{"date":376,"type":22},"2027-05-30",{"name":44,"class":45},{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":385,"targetDuration":4,"studyType":54,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":397,"locationsCount":68},"100498342","phase-2-study-of-shr-a1811-in-her2-expression-advanced-breast-cancer-with-brain-metastases-100498342","NCT05769010","Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases","A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases","Inclusion Criteria:\n\n1. Females and males ≥18 yrs old;\n2. Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;\n3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;\n4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;\n5. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.\n6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;\n7. Life expectancy is not less than 6 months.\n8. Adequate function of major organs.\n\nExclusion Criteria:\n\n1. Leptomeningeal involvement;\n2. CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;\n3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;\n4. Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;\n5. No concurrent antitumor therapy for metastatic cancer other than the study treatment;\n6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;\n7. Participated in other drug clinical trials within 4 weeks before admission;\n8. History of clinically significant lung disease；\n9. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.\n10. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).\n11. Any other conditions that researchers believe that patients are unsuitable for this study.",{"count":386,"type":22},150,[56],"This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.",[390],"Metastatic Breast Cancer","2026-03-27",{"date":393,"type":38},"2026-04-01",{"date":395,"type":38},"2023-03-31",{"date":312,"type":22},{"name":44,"class":45},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":405,"targetDuration":407,"studyType":23,"phases":4,"briefSummary":408,"conditions":409,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":410,"lastUpdatePostDateStruct":411,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":4},"100630802","cd20-monoclonal-antibody-based-first-line-therapy-in-treatment-naive-marginal-zone-b-cell-lymphoma-100630802","NCT07492407","CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma","Risk-Stratified Real-World Multicenter Study of the Efficacy and Safety of CD20 Monoclonal Antibody-Based First-Line Therapy in Treatment-Naive Marginal Zone B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed marginal zone B-cell lymphoma (MZL) in accordance with the 2016 WHO classification;\n* Age ≥ 18 years, with no gender restriction;\n* Patients with MZL requiring systemic therapy, including but not limited to:\n\n  1. Gastric extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), HP-positive or HP-negative, with progression\u002Frelapse after local therapy (including surgery, radiotherapy, and anti-Helicobacter pylori treatment);\n  2. Non-gastric MALT lymphoma:\n\n     Patients with Ann Arbor Stage I-II disease with progression\u002Frelapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;\n  3. Splenic marginal zone lymphoma (SMZL):\n\n     Patients with progression\u002Frelapse after local therapy (including splenectomy, antiviral therapy in HCV-positive patients, etc.); Or newly diagnosed with: progressive or painful splenomegaly, symptomatic or progressive cytopenia, defined as Hb \\\u003C 100 g\u002FL, PLT \\\u003C 80 × 10⁹\u002FL, or absolute neutrophil count (ANC) \\\u003C 1.0 × 10⁹\u002FL;\n  4. Nodal marginal zone lymphoma (NMZL):\n\nPatients with Ann Arbor Stage I-II disease with progression\u002Frelapse after local therapy (including surgery, radiotherapy, etc.); Patients with newly diagnosed Ann Arbor Stage III-IV disease meeting the GELF criteria as recommended by the NCCN Guidelines;\n\n* ECOG performance status 0, 1, or 2 (Appendix 4);\n* Adequate general condition, with a life expectancy \\> 3 months;\n* Adequate bone marrow function (except for cytopenia caused by the underlying disease), liver function, and renal function;\n* Commitment to comply with study procedures and cooperate throughout the entire study period;\n* The patient or his\u002Fher legally authorized representative must provide written informed consent prior to any study-specific tests or procedures;\n* For women of childbearing potential: agreement to use adequate contraceptive measures during study treatment and for at least 1 year after treatment completion.Men must agree to practice abstinence or use barrier contraception.\n\nExclusion Criteria:\n\n* Histological transformation to high-grade lymphoma.\n* Known central nervous system (CNS) involvement by lymphoma or evidence of CNS disease.\n* Prior systemic therapy, including immunotherapy, chemotherapy, or targeted therapy.\n* Prior autologous stem cell transplantation, or allogeneic tissue \u002F solid organ transplantation.\n* History of other invasive malignancies that were not treated with curative intent or for which anticancer treatment (including hormone therapy for breast or prostate cancer) was administered within the past 3 years.\n* Presence of uncontrolled cardiovascular or cerebrovascular diseases (e.g., New York Heart Association class III or IV heart failure, arrhythmia, myocardial infarction, stroke, or intracranial hemorrhage), coagulation disorders, connective tissue diseases, severe infectious diseases (including active tuberculosis), or other similar conditions.\n* Known human immunodeficiency virus (HIV) infection, or active hepatitis B or C virus infection (positive result by polymerase chain reaction \\[PCR\\]).Seropositivity is permitted; patients with HBV DNA \\\u003C 10³ IU\u002FmL may be enrolled. HCV RNA must be negative.\n* Administration of a live attenuated vaccine within 4 weeks prior to initiation of study treatment.Receipt of live attenuated vaccines, including influenza vaccines, is prohibited during the study period.\n* Requirement for continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers.",{"count":406,"type":22},131,"2 Years","This is a multicenter, real-world study on first-line CD20 monoclonal antibody-based regimens for treatment-naive marginal zone B-cell lymphoma based on risk stratification. The primary objective is to evaluate the efficacy and safety of the \"BR\", \"R2\", and \"OR2\" treatment regimens in treatment-naive MZL patients receiving first-line CD20 monoclonal antibody-based therapy stratified by risk.",[132],"2026-03-19",{"date":412,"type":38},"2026-03-25",{"date":414,"type":22},"2026-04",{"date":416,"type":22},"2028-02",{"name":44,"class":45},{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":4,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":425,"targetDuration":427,"studyType":23,"phases":4,"briefSummary":428,"conditions":429,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":68},"100629280","real-world-effectiveness-and-safety-of-glofitamab-in-primary-refractory-and-early-relapsed-diffuse-large-b-cell-lymphoma-100629280","NCT07472621","Real-World Effectiveness and Safety of Glofitamab in Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma","Efficacy and Safety of Glofitamab in the Real-World Treatment of Patients With Primary Refractory and Early Relapsed Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  1. Age ≥18 years at the time of treatment initiation.\n  2. Histologically or pathologically confirmed diffuse large B-cell lymphoma (DLBCL).\n  3. Patients with primary refractory disease or early relapse, defined as:\n\n     Failure to achieve complete response (CR) after at least 4 cycles of first-line induction therapy, or\n\n     Relapse confirmed by imaging within 12 months after achieving CR following first-line therapy.\n  4. Patients who plan to initiate a glofitamab-containing treatment regimen (either monotherapy or combination therapy) within 12 months after study initiation.\n  5. Willing and able to comply with study follow-up and data collection requirements.\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\n  1. Currently participating in, or planning to participate in, any interventional clinical trial.\n  2. Any condition that, in the investigator's judgment, would make the patient unsuitable for participation in this study (e.g., inability to complete follow-up, safety concerns, or significant comorbidities).",{"count":426,"type":22},20,"20 Years","This is a prospective, observational, non-interventional real-world study that will not alter participants' routine clinical care. Approximately 20 eligible patients with diffuse large B-cell lymphoma (DLBCL) will be enrolled. Treatment decisions will be made by the treating physician based on standard clinical practice and may include glofitamab monotherapy or glofitamab-based combination regimens, such as glofitamab plus gemcitabine and oxaliplatin (Glofit-GemOx) or glofitamab plus polatuzumab-based therapy (Glofit-Pola).\n\nThe study will collect baseline characteristics (including age, sex, medical history, and molecular subtype), treatment information, laboratory test results, adverse events, and survival follow-up data. Circulating tumor DNA (ctDNA) testing will be performed to assess minimal residual disease (MRD) in peripheral blood. When clinically indicated, cerebrospinal fluid samples may be collected to measure drug concentration.\n\nAll personal information will be kept strictly confidential. Identifiable information will be removed and replaced with coded study numbers. Medical records will be maintained at the study site and accessed only by authorized research personnel. Representatives from the sponsor, ethics committee, or regulatory authorities may review study records as required. Study results will be published in aggregated form without including any information that could identify individual participants. Study data and personal information will be used solely for research purposes.",[430],"DLBCL - Diffuse Large B Cell Lymphoma","2026-03-11",{"date":433,"type":38},"2026-03-16",{"date":435,"type":22},"2026-03-10",{"date":437,"type":22},"2028-12-01",{"name":44,"class":45},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":54,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100626996","a-cohort-study-on-the-prevention-of-nausea-and-vomiting-induced-by-concurrent-chemoradiotherapy-for-lung-cancer-using-rolapitant-and-palonosetron-100626996","NCT07442890","A Cohort Study on the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy for Lung Cancer Using Rolapitant and Palonosetron","A Cohort Study of the Combination Regimen Based on Rolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Concurrent Chemoradiotherapy in Lung Cancer Patients","Inclusion Criteria:\n\n1. Age ≥18 years, no gender restrictions;\n2. Histopathologically or cytologically confirmed lung cancer;\n3. Planned to receive concurrent chemoradiotherapy for at least 6 weeks, with radiotherapy administered in conventional fractions (2.0-2.2 Gy\u002Ffraction, 5 fractions\u002Fweek, total dose 60-66 Gy); chemotherapy regimen includes highly emetogenic agents (e.g., cisplatin ≥60 mg\u002Fm²) ;\n4. ECOG Performance Status score: 0-1;\n5. Expected survival \\>12 weeks;\n6. Adequate organ and bone marrow function;\n7. Willingness to complete daily nausea\u002Fvomiting logs and scale assessments.\n\nExclusion Criteria:\n\n1. Patients with imaging-confirmed brain metastases accompanied by symptoms of increased intracranial pressure (e.g., headache, vomiting, papilledema) or objective evidence of elevated intracranial pressure.\n2. Patients with a documented history of severe hypersensitivity to the active ingredient or excipients of the drug.\n3. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, dexamethasone, or olanzapine;\n4. Vomiting symptoms (≥1 episode\u002Fday) or VAS score ≥30 mm within 7 days prior to first administration;\n5. Use of medications with potential antiemetic effects within 2 days prior to first dose: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, secloperazine, etc.;\n6. Presence of conditions affecting vomiting assessment, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;\n7. History of epilepsy or current use of antiepileptic drugs;\n8. Pregnant or lactating women;\n9. History of severe psychiatric disorders, substance abuse, alcoholism, or drug addiction;\n10. Currently participating in another interventional clinical trial, or having received treatment with another investigational drug or device within 4 weeks prior to the first dose (subjects who failed screening for another clinical trial may be included in this study);\n11. Presence of any other factors deemed by the investigator to increase study risk, compromise patient compliance with the protocol, or affect the patient's ability to complete the trial, such as physiological or psychological conditions;",{"count":447,"type":22},238,[173],"This study aims to evaluate the efficacy and safety of a combination regimen based on Rolapitant Palonosetron injection for preventing nausea and vomiting induced by concurrent chemoradiotherapy in lung cancer patients. It will also analyze the differences in preventive efficacy between two combination regimens, filling the gap in antiemetic data for radiotherapy combined with moderately to highly emetogenic chemotherapy. This research will provide evidence for optimizing antiemetic strategies in patients undergoing concurrent chemoradiotherapy.",[451],"Lung Cancer","2026-02-24",{"date":454,"type":38},"2026-03-02",{"date":329,"type":22},{"date":457,"type":22},"2028-06-30",{"name":44,"class":45},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":362,"minAge":19,"maxAge":77,"enrollmentInfo":466,"targetDuration":4,"studyType":54,"phases":468,"briefSummary":469,"conditions":470,"keywords":471,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":4},"100624947","phase-2-trastuzumab-rezetecan-vs-trastuzumab-deruxtecan-in-the-neoadjuvant-treatment-of-her2-positive-breast-cancer-100624947","NCT07416253","Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer","A Randomized, Open-Label, Phase II Study Comparing the Efficacy and Safety of Trastuzumab-rezetecan and Trastuzumab Deruxtecan (T-DXd) in Neoadjuvant Treatment of Patients With HER2-Positive Early or Locally Advanced Breast Cancer","Inclusion Criteria:\n\n1. Female, 18-75 years old, treatment-naive\n2. ECOG PS 0-1\n3. Histologically confirmed HER2+ (IHC 3+ or IHC 2+\u002FISH+) early\u002Flocally advanced breast cancer (AJCC 8th: cT2-cT4 any N cM0) or cT1c N+ cM0; known ER\u002FPR status\n4. Adequate organ function (hematology\u002Fbiochemistry\u002Fcoagulation\u002Furine\u002Fcardiac)\n5. Negative pregnancy test (childbearing women); agree to effective contraception\n6. Sign an informed consent form.\n\nExclusion Criteria:\n\n1. Bbilateral\u002Finflammatory\u002Foccult breast cancer.\n2. Prior anti-tumor therapy (chemotherapy\u002Fradiotherapy\u002Ftargeted therapy, etc.); radical radiotherapy (4 weeks prior) or palliative radiotherapy (2 weeks prior) to first dose.\n3. Concurrent anti-tumor therapy; other malignancies (within past 5 years, except cured basal cell carcinoma\u002Fcervical CIS).\n4. Prior trial participation (past 4 weeks); systemic immunosuppressants\u002Fhormones (\\>10 mg\u002Fday prednisone equivalent, 2 weeks prior; nasal\u002Finhaled steroids excluded).\n5. Live\u002Fattenuated vaccine (past 4 weeks); major non-breast surgery (4 weeks prior, incomplete recovery).\n6. Active\u002Frelapsing autoimmune disease (except controlled hypothyroidism\u002Fwell-managed skin diseases\u002Ftype 1 diabetes); immunodeficiency (HIV+\u002Forgan transplant).\n7. Uncontrolled cardiovascular\u002Fcerebrovascular disease (e.g., MI\u002Fstroke in 6 months, NYHA III-IV heart failure, QTcF \\>470 msec \\[female\\]).\n8. Active ILD\u002Fsevere lung disease; active hepatitis B (HBsAg+ \\& HBV DNA ≥500 IU\u002FmL)\u002Fhepatitis C (HCV RNA+); severe infection requiring anti-infective therapy.\n9. Bleeding\u002Fthrombotic tendency; hypersensitivity to study drugs\u002Fexcipients.\n10. Pregnant\u002Flactating women; women of childbearing potential with positive pregnancy test or refusing contraception.\n11. Other conditions (e.g., uncontrolled hypertension\u002Fdiabetes, neuropsychiatric disorders) deemed unsuitable by the investigator.",{"count":467,"type":22},68,[56],"This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg\u002Fkg Q3W) or T-DXd (5.4 mg\u002Fkg Q3W) for 8 neoadjuvant cycles. After completing neoadjuvant treatment, patients will undergo definitive surgery, and tpCR will be assessed from resected specimens. Patients will then be followed up to monitor long-term efficacy (e.g., EFS) and late-onset adverse events. A total of 68 patients (34 per arm) will be enrolled to achieve the study's statistical objectives.",[176],[472,473],"HER2 positive","Antibody-drug conjugate","2026-02-10",{"date":476,"type":38},"2026-02-18",{"date":478,"type":22},"2026-03",{"date":480,"type":22},"2030-07",{"name":44,"class":45},{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":490,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":492,"conditions":493,"keywords":495,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":4},"100623741","anlotinib-in-cross-line-treatment-of-nsclc-and-sclc-100623741","NCT07400575","Anlotinib in Cross-line Treatment of NSCLC and SCLC","Multicenter, Retrospective, Real World Study of Anlotinib in Cross-line Treatment of NSCLC and SCLC","NSCLC SCLC","Inclusion Criteria:\n\nFrom October 1, 2018 to April 30, 2025, patients meeting all the following criteria will be included in this study:\n\n* Patients must be diagnosed with advanced metastatic non-small cell lung cancer (including squamous cell carcinoma, adenocarcinoma, etc.) or extensive-stage small cell lung cancer during the period from October 1, 2018 to April 30, 2025.\n* Patients clinically documented as having driver gene-negative advanced metastatic non-small cell lung cancer or extensive-stage small cell lung cancer, who were treated with anlotinib during the treatment period and continued using anlotinib after disease progression (with at least 4 months of continuous medication records in the medical records), or other immune or chemotherapy drugs.\n* Patients who underwent at least one imaging examination within 90 days before reapplication of anlotinib or other immune or chemotherapy drugs after progression during anlotinib treatment, and subsequently had at least two imaging examinations.\n\nExclusion Criteria:\n\nFrom October 1, 2018 to April 30, 2025, patients meeting any of the following criteria will be excluded from this study:\n\n* Patients who received other TKI-class anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) before the first application of anlotinib treatment.\n* Patients who received other anti-angiogenic drugs (including but not limited to bevacizumab, recombinant human endostatin, pazopanib, regorafenib, cabozantinib, sunitinib, sorafenib, apatinib, axitinib, lenvatinib, fruquintinib, vandetanib, cediranib, nintedanib, pralsetinib, selpercatinib, alectinib, ponatinib) after progression.\n* Patients who underwent surgical treatment during anlotinib therapy. - Patients with driver gene positivity.\n* Patients with concurrent other malignant tumors. - Pathological subtypes: advanced metastatic non-small cell lung cancer, including but not limited to large cell carcinoma, adenosquamous carcinoma, carcinoid, pulmonary sarcomatoid carcinoma; extensive-stage small cell lung cancer, including but not limited to oat cell type, mixed type, etc.",{"count":491,"type":22},350,"Previous studies on bevacizumab in colorectal and ovarian cancers have demonstrated that continued anti-angiogenic therapy after disease progression can still provide clinical benefits. As a typical multi-targeted anti-angiogenic tyrosine kinase inhibitor, anlotinib hydrochloride has been approved in China for second-line or later treatment of advanced soft tissue sarcoma, where it has also shown significant potential. Retrospective studies have indicated the effectiveness of anlotinib in cross-line treatment for sarcoma. However, there is a lack of multi-center real-world studies evaluating the clinical efficacy of anlotinib in cross-line treatment for driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer.\n\nThis study aims to evaluate, through a retrospective multi-center study, the efficacy and safety of anlotinib monotherapy or combination regimens in the later-line treatment of driver gene-negative advanced metastatic non-small cell lung cancer and extensive-stage small cell lung cancer after anlotinib treatment failure, providing clinical evidence for cross-line therapy.",[494,202],"NSCLC (Advanced Non-small Cell Lung Cancer)",[496,497,498],"Anlotinib","mNSCLC","ES-SCLC","2026-02-03",{"date":474,"type":38},{"date":502,"type":22},"2026-02-01",{"date":237,"type":22},{"name":44,"class":45},{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":511,"targetDuration":4,"studyType":54,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":4},"100620891","phase-2-efficacy-and-safety-of-radiotherapy-combined-with-tislelizumab-and-anlotinib-in-the-treatment-of-hepatocellular-carcinoma-complicated-with-portal-vein-tumor-thrombus-100620891","NCT07363512","Efficacy and Safety of Radiotherapy Combined With Tislelizumab and Anlotinib in the Treatment of Hepatocellular Carcinoma Complicated With Portal Vein Tumor Thrombus","Inclusion Criteria:\n\n1. Men aged between 18 and 75 or non-pregnant women;\n2. Sign the informed consent form;\n3. The researchers believe that the patients have the ability to comply with the research protocol;\n4. Hepatocellular carcinoma (HCC) is diagnosed histologically, cytologically or clinically. Patients with liver cirrhosis are clinically diagnosed according to the AASLD standard, while non-liver cirrhosis patients need to be confirmed by histology.\n5. Imaging examinations confirmed the presence of portal vein tumor thrombus;\n6. The disease is not suitable for radical surgery;\n7. Has not received any anti-tumor treatment in the past;\n8. At least one measurable (measurable according to RECIST1.1) untreated lesion;\n9. Tumor tissue samples before treatment (if available). If tumor tissue is available, submit one formalin-fixed, paraffin-embedded (FFPE) tumor sample in a paraffin block (preferred), or approximately 10-15 slides containing unstained, freshly cut, series sections, along with a relevant pathological report within 4 weeks of enrollment. If the FFPE samples described above are not available, any type of sample (including fine needle aspiration biopsy samples and cell mass samples) can also be accepted. A relevant pathological report should be provided along with the sample.\n10. The ECOG performance status score is 0 or 1;\n11. Child-Pugh grade A;\n12. Adequate hematology and organ function, based on the following laboratory test results obtained within 7 days before enrollment (unless otherwise specified) : absolute neutrophil count (ANC)≥1.5×109\u002FL (1500\u002FμL), no granulocyte colony-stimulating factor support; Lymphocyte count ≥0.5×109\u002FL (500\u002FμL); Platelet count ≥50×109\u002FL (50,000 \u002FμL), no blood transfusion; Hemoglobin ≥90 g\u002FL (9g\u002FdL);\n13. Before enrollment, any acute and clinically significant treatment-related toxicity (caused by previous treatment) must have been alleviated to ≤ grade 1, except for alopecia.\n14. The result of the HIV antibody test during screening was negative;\n15. Patients with active hepatitis B virus (HBV) infection: HBV DNA obtained within 28 days before randomization \\\u003C 2000IU\u002FmL, and having received at least 14 days of anti-HBV treatment (treated according to local standard treatment, such as entecavir) before randomization and willing to continue treatment during the study period.\n\nExclusion Criteria:\n\n1. Current or previous history of autoimmune diseases or immune deficiencies\n2. History of meningitis;\n3. Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia can be seen on chest computed tomography (CT) images during the screening period. Radiation pneumonia has been allowed in the radiation area (fibrosis).\n4. Known active tuberculosis;\n5. Having major cardiovascular diseases (such as New York Heart Society Class II or more severe heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months prior to enrollment;\n6. History of congenital long QT syndrome or corrected QT interval at screening \\>500ms (calculated using the Fridericia method);\n7. A history of uncorrectable electrolyte disorders such as serum potassium, calcium or magnesium;\n8. Received major surgical treatment (excluding diagnosis) within 4 weeks before enrollment or is expected to require major surgical treatment during the study period;\n9. Malignant tumors other than HCC that have occurred within 5 years prior to enrollment, excluding those with negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%), such as well-treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, carcinoma in situ or stage I uterine cancer;\n10. There was a severe infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection, bacteremia or severe pneumonia complications;\n11. Previous allogeneic stem cell or solid organ transplantation;\n12. The patient cannot be followed up or is currently participating in other clinical trials;\n13. Subjects who the researchers considered unsuitable for inclusion in this study.",{"count":512,"type":22},27,[56],"For HCC patients with PVTT who the researchers believe can benefit from radiotherapy combined with tislelizumab and anlotinib, informed consent forms will be signed, and then they will receive the study treatment and be followed up. The research design is as follows:\n\nFirst, radiotherapy was administered. Three days ±1 day after the start of radiotherapy, tislelizumab and anlotinib treatment were initiated. Each cycle was three weeks, and the treatment continued until no toxicity was acceptable or clinical benefits were lost (evaluated by the researcher based on imaging, biochemical indicators, and the patient's clinical status).",[280],"2026-01-14",{"date":518,"type":38},"2026-01-23",{"date":520,"type":22},"2026-01-05",{"date":522,"type":22},"2028-11",{"name":44,"class":45},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":531,"targetDuration":4,"studyType":54,"phases":533,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100618484","phase-3-application-of-toripalimab-as-adjuvant-therapy-after-esophageal-cancer-surgery-a-multicenter-clinical-trial-100618484","NCT07332221","Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial","Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter, Phase III Clinical Trial","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.\n2. Initial patients are those with resectable or potentially resectable (T1 N1-3 M0 or T2-3 N0-3 M0) thoracic segment esophageal squamous cell carcinoma (8th UICC-TNM staging); who have undergone surgical resection after 2 cycles of immunotherapy combined with chemotherapy and achieved R0 resection.\n3. Age 18 to 75 years.\n4. Preoperative examinations of various organ functions indicate no surgical contraindications.\n5. The following laboratory tests confirm that bone marrow, liver, and kidney functions meet the study requirements:\n\n   Hemoglobin ≥ 90 g\u002FL; White blood cell count ≥ 4.0 × 10⁹\u002FL; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 times ULN; International normalized ratio (INR) of prothrombin time ≤ 1.5 times ULN, and activated partial thromboplastin time within the normal range; Creatinine ≤ 1.5 times ULN.\n6. No postoperative chemotherapy, radiotherapy, or hormone therapy for malignant tumors has been administered; no history of other malignancies, excluding prostate cancer patients who have received hormone therapy and achieved disease-free survival (DFS) for over 5 years.\n7. Physical status ECOG score 0 to 1.\n8. Women of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after study completion; serum or urine pregnancy test within 7 days before study enrollment must be negative, and patients must be non-lactating; men must agree to use contraceptive measures during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n1. Patients with double primary cancers;\n2. Patients with infections requiring treatment;\n3. Patients requiring continuous systemic corticosteroid therapy (Note: Replacement therapy (e.g., for thyroid insufficiency, insulin therapy, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy and is permitted);\n4. Patients with unstable angina within 3 months or myocardial infarction within 6 months;\n5. Patients with psychiatric disorders;\n6. Patients with existing or concurrent hemorrhagic disorders;\n7. Female patients who are pregnant or breastfeeding;\n8. Patients with bronchial asthma requiring intermittent use of bronchodilators or medical intervention;\n9. Patients who have used immunosuppressive agents prior to enrollment due to comorbid conditions, with a dose equivalent to ≥10mg\u002Fday of oral prednisone sustained for more than 2 weeks;\n10. Patients with abnormal coagulation function (PT \\> 16s, APTT \\> 53s, TT \\> 21s, Fib \\\u003C 1.5g\u002FL), bleeding tendency, or those receiving thrombolytic or anticoagulant therapy;\n11. Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe pulmonary impairment, etc.;\n12. Patients with autoimmune diseases, immunodeficiency, or organ transplantation;\n13. Patients with active Hepatitis B or Hepatitis C infection.",{"count":532,"type":22},435,[107],"This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.",[28],"2026-01-09",{"date":538,"type":38},"2026-01-12",{"date":351,"type":22},{"date":541,"type":22},"2031-10-01",{"name":44,"class":45},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":550,"targetDuration":4,"studyType":54,"phases":551,"briefSummary":552,"conditions":553,"keywords":554,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":562,"leadSponsor":564,"locationsCount":68},"100590414","phase-2-ql1706-for-the-neoadjuvant-treatment-of-hrher2--breast-cancer-100590414","NCT06967103","QL1706 for the Neoadjuvant Treatment of HR+\u002FHER2- Breast Cancer","QL1706 Combined With PE Compared With PE for the Neoadjuvant Treatment of HR+\u002FHER2- Breast Cancer","Inclusion Criteria\n\nSubjects meeting all of the following criteria are eligible for inclusion in this study:\n\nVoluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.\n\nFemale, aged ≥18 years .\n\nEvaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.\n\ncT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；\n\nHistologically and\u002For cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor \\[ER\\] or progesterone receptor \\[PR\\] nuclear staining \\>1%) with Ki67 ≥20%.\n\nHER2-negative breast cancer, defined as:\n\nNegative in situ hybridization (ISH) results; or\n\nImmunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.\n\nWilling to provide fresh or archived tumor tissue samples.\n\nAt least one measurable lesion per RECIST 1.1 criteria.\n\nEastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nAdequate organ function, defined as:\n\nHematology:\n\nHemoglobin ≥90 g\u002FL\n\nAbsolute neutrophil count ≥1.5 × 10⁹\u002FL\n\nPlatelet count ≥100 × 10⁹\u002FL.\n\nBiochemistry:\n\nALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present);\n\nTotal bilirubin ≤1.5 × ULN;\n\nSerum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL\u002Fmin.\n\nCoagulation:\n\nActivated partial thromboplastin time (APTT) ≤1.5 × ULN;\n\nInternational normalized ratio (INR) ≤1.5 × ULN.\n\nCardiac function:\n\nLeft ventricular ejection fraction (LVEF) ≥50% by echocardiography.\n\nPremenopausal or perimenopausal subjects must agree to use reliable and effective contraception or practice abstinence from the time of informed consent until at least 90 days after the last dose of study treatment.\n\nExclusion Criteria\n\nSubjects meeting any of the following criteria will be excluded from this study:\n\nKnown severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.\n\nStage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.\n\nInflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).\n\nMajor surgery or significant trauma within 28 days prior to the first dose.\n\nAdministration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.\n\nSystemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study.\n\nActive autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders.\n\nSevere systemic infection within 28 days or active infection requiring intravenous\u002Foral antibiotics within 14 days prior to the first dose.\n\nPrior organ or allogeneic bone marrow transplantation or awaiting transplantation.\n\nHistory or evidence of interstitial lung disease or active non-infectious pneumonitis.\n\nBleeding tendency or high risk of hemorrhage.\n\nThromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment.\n\nCongenital or acquired immunodeficiency (e.g., HIV infection).\n\nActive hepatitis:\n\nHepatitis B: HBsAg-positive with HBV DNA ≥2000 IU\u002FmL;\n\nHepatitis C: HCV antibody-positive with HCV RNA above the upper limit of normal.\n\nPoorly controlled cardiac conditions, including:\n\nNYHA Class II or higher heart failure or LVEF \\\u003C50%;\n\nUnstable angina;\n\nMyocardial infarction within 1 year;\n\nQTc interval \\>470 ms (female) on resting ECG.\n\nOther malignancies within 5 years (excluding basal cell carcinoma or cervical carcinoma in situ).\n\nUse of investigational drugs within 4 weeks prior to the first dose.\n\nHistory or current diagnosis of neurological or psychiatric disorders (e.g., epilepsy, dementia).\n\nHistory of pancreatitis.\n\nPregnancy, lactation, or refusal to use contraception.\n\nAny other condition deemed inappropriate for participation by the investigator.",{"count":447,"type":22},[56],"The goal of this clinical trial is to learn if QL1706 is effective in early HR+\u002FHER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:\n\nDoes QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+\u002FHER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.",[176,59],[555,556,557],"PD1","CTLA4","breast cancer","2026-01-07",{"date":560,"type":38},"2026-01-08",{"date":331,"type":38},{"date":563,"type":22},"2029-05-30",{"name":44,"class":45},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":77,"enrollmentInfo":572,"targetDuration":4,"studyType":54,"phases":573,"briefSummary":574,"conditions":575,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":68},"100618654","phase-1-fruquintinib-combined-with-trastuzumab-and-xelox-as-first-line-treatment-in-patients-with-her2-positive-advanced-gastric-cancer-100618654","NCT07334431","Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric Cancer","Fruquintinib Combined With Trastuzumab and XELOX as First-line Treatment in Patients With HER2-positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: an Open-label, Single-arm, Single-center Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n* Have fully understood the study and voluntarily signed the informed consent;\n* 18-75 years old (including 18 and 75 years old);\n* Pathologically determined advanced gastric or gastroesophageal junction adenocarcinoma;\n* No previous anti-tumor treatment for metastatic diseases;\n* HER2 positive;\n* Eastern Cooperation Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥ 3 months;\n* At least one measurable lesion according to RECIST version 1.1;\n* The functions of vital organs met the following requirements (Blood components and cell growth factors were not allowed within 14 days before enrollment):\n\n  * Absolute neutrophil count ≥1.5×109\u002FL;\n  * Platelet ≥100×109 \u002FL;\n  * Hemoglobin ≥90g\u002FL;\n  * Total bilirubin \\\u003C 1.5 ULN;\n  * ALT and\u002For AST \\\u003C 1.5 ULN ;\n  * Serum creatinine (Cr) \\\u003C1.5×ULN;\n  * Endogenous creatinine clearance ≥50ml\u002Fmin;\n* Female patients of childbearing age should take effective contraceptive measures;\n* Good compliance, cooperate with follow-up.\n\nExclusion Criteria:\n\n* Failure to comply with the study protocol or study procedure;\n* Previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitors, chemotherapy or immune checkpoint inhibitors;\n* Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;\n* Known presence of symptomatic central nervous system metastasis or brain metastases;\n* Had autoimmune disease or history of autoimmune disease within 4 weeks before enrollment;\n* Previously received allogeneic bone marrow transplantation or organ transplantation;\n* Uncontrolled malignant ascites (defined as ascites that cannot be controlled by diuretics or puncture as determined by the researcher);\n* Severe cardiovascular disease, including unstable angina pectoris or myocardial infarction, occurs within 6 months before the start of study treatment;\n* Subjects who are allergic to the investigational drug or any of its adjuncts;\n* Participated in other domestic unapproved or unmarketed drug clinical trials and accepted the corresponding experimental drug treatment within 4 weeks before enrollment;\n* International Standardized Ratio (INR) \\>1.5 or partially activated prothrombin time (APTT) \\>1.5×ULN;\n* The investigator identified clinically significant electrolyte abnormalities;\n* Hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg;\n* Poorly controlled diabetes mellitus was present before enrollment (fasting glucose concentration ≥CTCAE level 2 after formal treatment);\n* Had any disease or condition prior to enrollment that affected drug absorption, or the patient could not take fruquintinib orally;\n* Gastrointestinal diseases such as active ulcer of stomach and duodenum, ulcerative colitis, or active bleeding of unresectosed tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by researchers before enrollment;\n* Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \\>30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \\>5 mL of fresh blood) or had a thromboembolic event (including stroke events and\u002For transient ischemic attacks) within 12 months;\n* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\\u003C50%;\n* Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe\u002Funstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \\>Level 2; Ventricular arrhythmias requiring medical treatment; LVEF (Left ventricular Ejection Fraction) \\>50%;\n* Unmitigated toxicity higher than CTCAE v5.0 grade 1 due to any previous anticancer therapy, excluding alopecia, lymphocytopenia, and oxaliplatin grade ≤2 neurotoxicity;\n* Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n* Received blood transfusion therapy, blood products and hematopoietic factors, such as albumin and granulocyte colony-stimulating factor (G-CSF), within 14 days before enrollment;\n* Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, reasonably suspects that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or which would affect the interpretation of the study results or place the patient at high risk；\n* Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \\> 1.0g;\n* Complications require long-term treatment with immunosuppressants or systemic or local use of immunosuppressive corticosteroids (\\> 10mg\u002F day prednisone or other therapeutic hormone);\n* Investigators believe that the patient has any other conditions that are not suitable for participating in the study.",{"count":247,"type":22},[222,56],"This study was designed to evaluate the safety and efficacy of fruquintinib plus trastuzumab, and XELOX as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.",[303,576,577,578,579,580],"Gastric (Stomach) Cancer","GEJ Adenocarcinoma","HER2-positive Gastric Cancer","First-line Therapy","Fruquintinib","2025-12-30",{"date":538,"type":38},{"date":584,"type":38},"2024-02-22",{"date":586,"type":22},"2026-12-31",{"name":44,"class":45},""]