[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sichuan University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":603},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,56,0,25,[9,44,76,108,133,154,175,190,215,241,263,283,305,326,349,376,400,423,448,466,484,507,531,556,577],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652033","early-phase-1-safety-tolerability-and-preliminary-efficacy-of-211atmabg-in-patients-with-relapsed-or-refractory-neuroblastoma-100652033",false,"NCT07767630","Safety, Tolerability, and Preliminary Efficacy of [211At]MABG in Patients With Relapsed or Refractory Neuroblastoma","An Exploratory Proof-of-Concept (POC) Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of Fractionated Dosing of [211At]MABG in Patients With Relapsed or Refractory Neuroblastoma (Including a Run-in Phase)","Inclusion Criteria:\n\n1. Patients diagnosed with MIBG avid lesions, high-risk neuroblastoma per the Revised International Neuroblastoma Response Criteria (Revised INRC), with refractory, relapsed, or progressive disease.\n2. All measurable soft tissue lesions must be MIBG-avid.\n3. Age ≥ 1 year at enrollment.\n4. Lansky performance status ≥ 50%.\n5. Adequate organ function and hematologic parameters.\n\nExclusion Criteria:\n\n1. Antibody-based immunotherapy within fewer than 5 half-lives or 30 days (whichever is shorter), or who have not yet recovered from adverse effects of any biologic therapy.\n2. Treatment with \\[¹³¹I\\]MIBG or Lu177 targeted radionuclide therapy less than 3 months of last administration.\n3. Autologous stem cell transplant \\\u003C12 weeks, or Allogeneic stem cell transplant \\\u003C4 months (patients \\>4 months post-transplant must be free of active GVHD).\n4. Radiotherapy within 2 weeks prior to the first study dose (However, patients with a single-site irradiation that remains MIBG avid may be enrolled.) or extensive-field radiotherapy (e.g., craniospinal, whole abdomen, whole lung, or \\>50% of bone marrow area) within 12 weeks prior to the first study dose.\n5. Renal Insufficiency.\n6. Active Infections.","ALL","1 Year","100 Years",{"count":21,"type":22},10,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","Fractionated dosing of \\[211At\\]MABG Radiotherapy in Relapsed\u002FRefractory Neuroblastoma",[28],"Neuroblastoma (NB)",[30],"Radiopharmaceutical","RECRUITING","2026-08-19",{"date":34,"type":35},"2026-08-21","ACTUAL",{"date":37,"type":35},"2026-07-21",{"date":39,"type":22},"2027-06-30",{"name":41,"class":42},"Sichuan University","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100475976","phase-1-dual-targeting-vegfr1-and-pd-l1-car-t-for-cancers-patients-with-pleural-or-peritoneal-metastases-100475976","NCT05477927","Dual-targeting VEGFR1 and PD-L1 CAR-T for Pleural, Peritoneal, or Leptomeningeal Metastases","A Phase I, Open-label, Single-arm, Dose-escalation and Expansion Study of Dual-targeting VEGFR1 and PD-L1 CAR-T Cells in Patients With Pleural, Peritoneal, or Leptomeningeal Metastases From Solid Tumors","* Inclusion Criteria\n\n  1. Male or female participants aged 18 to 75 years. Participants older than 75 years may be enrolled at the investigator's discretion based on overall health status.\n  2. Females of childbearing potential must have a negative serum or urine pregnancy test. Females who have undergone surgical sterilization or have been postmenopausal for at least 2 years are considered not of childbearing potential.\n  3. Histologically or cytologically confirmed advanced solid tumors with evidence of serosal cavity metastasis (pleural\u002Fperitoneal) and\u002For leptomeningeal metastasis, who have failed standard-of-care therapies.For leptomeningeal metastasis: patients must have received at least 3 intrathecal chemotherapy infusions with persistent positive CSF cytology and neurological symptoms, OR have re-positivity of CSF cytology after prior clearance.\n  4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n  5. Life expectancy \\> 3 months.\n  6. Adequate organ and bone marrow function:\n\n     Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL Platelets ≥ 90 × 10⁹\u002FL Absolute lymphocyte count ≥ 1.0 × 10⁸\u002FL Hemoglobin ≥ 9.0 g\u002FdL ALT\u002FAST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases) Total bilirubin ≤ 1.5 × ULN Creatinine \\\u003C 1.5 × ULN AND creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula). Creatinine clearance assessment is required only when creatinine ≥ 1.5 × ULN.\n  7. Cardiac ejection fraction ≥ 50%. Patients with minimal or moderate pericardial effusion may be enrolled at the investigator's discretion.\n  8. No other severe concurrent diseases (e.g., active autoimmune diseases, immunodeficiency).\n  9. Chemotherapy must be discontinued for at least 3 weeks prior to CAR-T cell infusion.\n  10. Sexually active participants of childbearing potential must agree to use highly effective contraceptive methods from screening through 1 year after CAR-T cell infusion.\n  11. Voluntary participation with written informed consent obtained prior to any study-specific procedures.\n  12. Recovery from prior antitumor therapy to ≤ Grade 1 (CTCAE v5.0), except for alopecia, hormone-replacement-controlled hypothyroidism, Grade 2 peripheral neuropathy, vitiligo, well-controlled diabetes, or other chronic toxicities deemed by the investigator to be stable and not interfering with study conduct.\n* Exclusion Criteria\n\n  1. Known hypersensitivity to cytokines.\n  2. Active infection requiring systemic anti-infective therapy.\n  3. Acute or chronic graft-versus-host disease (GVHD).\n  4. History of malignancies other than the target indication within 5 years prior to screening, with the exception of adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast after curative resection.\n  5. Active hepatitis B or C, or HIV infection. HBsAg-positive patients may be enrolled if HBV DNA is below the lower limit of normal (LLN) per institutional standard; HCV antibody-positive patients may be enrolled if HCV RNA is below LLN per institutional standard. Carriers require antiviral therapy as clinically indicated and periodic quantitative nucleic acid testing during the study.\n  6. Prior immunotherapy-related adverse event of Grade ≥ 3, or any other concurrent disease, metabolic dysfunction, physical examination finding, or laboratory abnormality that would reasonably preclude use of the investigational product, confound study results, or place the participant at undue risk.\n  7. Clinically significant cardiovascular disease, including but not limited to:Congestive heart failure (NYHA Class \\> 2);Unstable angina;Myocardial infarction within the past 3 months;Supraventricular or ventricular arrhythmia requiring treatment or intervention;Poorly controlled Grade 2-3 hypertension\n  8. Known psychiatric disorders, alcoholism, drug abuse, or substance dependence that may interfere with study compliance.\n  9. Active autoimmune disease, history of autoimmune disease, or condition requiring systemic corticosteroids (\\> 10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy (e.g., post-organ transplantation). Inhaled corticosteroids are permitted.\n  10. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial\u002Fvenous thromboembolic events within 6 months prior to enrollment. Patients on anticoagulation therapy must be on a stable dose prior to enrollment.\n  11. Pregnant or lactating women, or women planning pregnancy during the treatment period or within 1 year after CAR-T cell infusion.Women of childbearing potential unwilling to use highly effective contraception during the treatment period and for 1 year after CAR-T cell infusion. A negative serum or urine pregnancy test (within 48 hours prior to treatment) is required for women of childbearing potential.\n  12. Any condition that, in the investigator's opinion, precludes the participant from providing written informed consent or complying with study procedures.\n  13. Any other condition deemed by the investigator as inappropriate for study participation.","18 Years","80 Years",{"count":54,"type":22},40,[56],"PHASE1","This is a Phase I, open-label, single-arm, dose-escalation and expansion study designed to evaluate the safety, tolerability, and preliminary antitumor activity of dual-targeting VEGFR1\u002FPD-L1 chimeric antigen receptor (CAR) T-cells in patients with solid tumors presenting with pleural, peritoneal, or leptomeningeal metastases.\n\nDespite advances in systemic therapies, patients with serosal cavity and leptomeningeal dissemination face extremely poor prognoses and limited treatment options due to the unique immunosuppressive tumor microenvironment and the physical barrier of these anatomical sites. Preclinical evidence suggests that simultaneous blockade of VEGFR1-mediated angiogenesis and PD-L1-mediated immune checkpoint signaling via a bispecific CAR-T construct may synergistically overcome local immunosuppression and enhance tumor eradication in these sanctuary sites.\n\nThe study consists of two phases: a dose-escalation phase utilizing a standard 3+3 design and backfilling design to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of locoregionally administered CAR-T cells, followed by a dose-expansion phase to further assess safety and preliminary efficacy at the RP2D.\n\nEligible patients will receive a single infusion of VEGFR1\u002FPD-L1 dual-CAR T-cells via intrapleural, intraperitoneal, or intrathecal routes, depending on the primary site of metastasis. The primary endpoints are the incidence of dose-limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0. Secondary endpoints include objective response rate (ORR) , progression-free survival (PFS), overall survival (OS), and assessment of CAR-T cell persistence and cytokine profiles in peripheral blood and local effusion fluids.",[59,60,61,62],"Malignant Peritoneal Effusion","Malignant Ascites","Serous Cavity Metastatises","Leptomeningeal Metastases",[64,65,66,67],"CAR-T regional injection","Solid Tumors","Serosal Cavity metastases","leptomeningeal metastases","2026-08-11",{"date":70,"type":35},"2026-08-13",{"date":72,"type":35},"2023-02-15",{"date":74,"type":22},"2028-12-31",{"name":41,"class":42},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":94,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100650495","phase-2-adjuvant-immune-checkpoint-inhibitor-versus-observation-after-neoadjuvant-immunochemotherapy-and-surgery-in-high-risk-nsclc-100650495","NCT07748325","Adjuvant Immune Checkpoint Inhibitor Versus Observation After Neoadjuvant Immunochemotherapy and Surgery in High-Risk NSCLC","Adjuvant Immune Checkpoint Inhibitor Versus Observation in Patients With Completely Resected Non-Small Cell Lung Cancer at High Risk of Recurrence After Neoadjuvant Immunochemotherapy: A Multicenter, Randomized, Open-Label, Phase II Trial","RICA","Inclusion Criteria:\n\n1. Male or female participants aged 18 to 75 years.\n2. Histologically or cytologically confirmed non-small cell lung cancer.\n3. Completion of 2 to 4 cycles of neoadjuvant immune checkpoint inhibitor therapy combined with chemotherapy, followed by complete (R0) surgical resection.\n4. At least one of the following protocol-defined high-risk features for postoperative recurrence:\n\n   * Pathologic lymph-node involvement;\n   * Postoperative pathologic T2 or higher disease;\n   * Failure to achieve a major pathologic response, defined as more than 10% residual viable tumor cells in the primary tumor;\n   * Pleural invasion;\n   * Intravascular tumor emboli;\n   * High-risk histologic components, including solid, micropapillary, or adenosquamous components;\n   * Detectable molecular residual disease.\n5. For participants with lung adenocarcinoma, absence of sensitizing EGFR mutations and ALK rearrangements. Molecular testing is not mandatory for participants with squamous cell carcinoma according to the current protocol.\n6. Eastern Cooperative Oncology Group performance status of 0 or 1.\n7. Adequate organ function within 7 days before randomization, as demonstrated by all of the following:\n\n   * Hemoglobin of at least 90 g\u002FL;\n   * Absolute neutrophil count of at least 1.5 × 10\\^9\u002FL;\n   * Platelet count of at least 75 × 10\\^9\u002FL;\n   * Total bilirubin no greater than 1.5 times the upper limit of normal;\n   * Alanine aminotransferase and aspartate aminotransferase no greater than 2.5 times the upper limit of normal;\n   * Serum creatinine no greater than 1.5 times the upper limit of normal or creatinine clearance of at least 60 mL\u002Fmin;\n   * Left ventricular ejection fraction of at least 50%;\n   * International normalized ratio or prothrombin time no greater than 1.5 times the upper limit of normal.\n8. Women of childbearing potential must have a negative pregnancy test within 7 days before the first dose and must agree to use effective contraception during the study and for 3 months after the last dose of study treatment. Male participants with partners of childbearing potential must agree to use effective contraception during the study and for 8 weeks after the last dose.\n9. Ability to understand the study requirements, willingness to provide written informed consent, and ability to comply with study treatment and follow-up procedures.\n\nExclusion Criteria:\n\n1. Small cell lung cancer or non-small cell lung cancer containing a small cell carcinoma component.\n2. Incomplete resection, including R1 or R2 resection, or salvage surgery.\n3. Clinically significant malnutrition as determined by the investigator.\n4. A history of clinically significant immune-related adverse events during prior treatment, including grade 3 or higher immune-mediated pneumonitis, myocarditis, or another serious immune-related adverse event that, in the investigator's judgment, makes further immune checkpoint inhibitor therapy unsafe.\n5. Signs, symptoms, or a known history of clinically significant interstitial lung disease.\n6. Any severe or uncontrolled concurrent medical condition, including:\n\n   * Inadequately controlled hypertension;\n   * Grade 2 or higher myocardial ischemia, myocardial infarction, clinically significant arrhythmia, corrected QT interval of at least 480 milliseconds, or New York Heart Association class II or higher heart failure;\n   * Active or uncontrolled infection of grade 2 or higher;\n   * Decompensated liver disease, active hepatitis, or chronic viral hepatitis requiring antiviral therapy;\n   * Renal failure requiring hemodialysis or peritoneal dialysis;\n   * Known human immunodeficiency virus infection, another acquired or congenital immunodeficiency disorder, or a history of organ transplantation;\n   * Poorly controlled diabetes mellitus, defined as fasting blood glucose greater than 10 mmol\u002FL;\n   * Urine protein of 2+ or greater with a 24-hour urinary protein level greater than 1.0 g;\n   * Clinically significant coagulation abnormalities or an increased risk of bleeding;\n   * A seizure disorder requiring treatment.\n7. A concurrent active malignancy, except for malignancies specifically permitted by the final protocol.\n8. An active autoimmune disease or another immune-mediated disease requiring systemic treatment.\n9. Long-term treatment with systemic immunosuppressive therapy or systemic corticosteroids, except for protocol-permitted physiologic replacement therapy.\n10. An active psychiatric disorder, cognitive impairment, or another condition that would prevent provision of informed consent or adherence to study treatment and follow-up.\n11. Any other condition that, in the investigator's judgment, makes the participant unsuitable for the study.","75 Years",{"count":86,"type":22},100,[88],"PHASE2","This multicenter, randomized, open-label, phase II trial is designed to evaluate the efficacy and safety of adjuvant sintilimab in patients with completely resected non-small cell lung cancer who remain at high risk of recurrence after neoadjuvant immunochemotherapy.\n\nApproximately 100 eligible participants will be randomly assigned in a 1:1 ratio to receive either adjuvant sintilimab or observation. Participants assigned to the experimental arm will receive sintilimab at a dose of 200 mg intravenously every 4 weeks for up to 1 year, unless disease recurrence or progression, unacceptable toxicity, withdrawal of consent, or another protocol-defined discontinuation criterion occurs.\n\nThe primary outcome is the 18-month disease-free survival rate. Secondary outcomes include disease-free survival, overall survival, and safety. Peripheral blood and tumor tissue samples will also be collected for exploratory analyses of ctDNA, antitumor immune responses, and tumor immune microenvironment biomarkers.",[91,92,93],"Non-Small Cell Lung Cancer","Adjuvant Therapy","Immune Checkpoint Inhibitors",[95,96,97,98],"Adjuvant immunotherapy","Non-small cell lung cancer","Circulating tumor DNA","Immune checkpoint inhibitor","2026-08-03",{"date":101,"type":35},"2026-08-05",{"date":103,"type":35},"2025-01-10",{"date":105,"type":22},"2028-12-30",{"name":41,"class":42},2,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":115,"enrollmentInfo":116,"targetDuration":4,"studyType":23,"phases":118,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":43},"100542894","phase-1-phase-i-clinical-study-of--pd-l1dll3-car-t-in-patients-with-rr-sclc-100542894","NCT06348797","Phase I Clinical Study of α-PD-L1\u002FDLL3 CAR-T in Patients With R\u002FR SCLC","Phase I Clinical Study on Safety and Feasibility of DLL3 Targeted α-PD-L1\u002F4-1BB Modifying Chimeric Antigen Receptor T-cells in Patients With Relapsed or Refractory Small Cell Lung Cancer (SCLC)","Inclusion Criteria:\n\n* Patients with recurrent or refractory small cell lung cancer (SCLC) confirmed by histology or cytology who have relapsed or progressed after treatment with one previous platinum-based regimen;\n* Patients can provide sufficient tumor tissue (fresh or paraffin sections, etc.);\n* Age 18 \\~70 (including boundary), for both men and women;\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n* Life expectancy ≥3 months;\n* At least one extracranial measurable lesion (RECIST v1.1) exists；for lesion after radiotherapy， must be confirmed that the lesion has progressed ;\n* Patients in limited-stage at the initial diagnosis must undergo radical thoracic radiotherapy and the time of tumor progression is not less than 1 months from the end of radiotherapy, or radical thoracic dose radiotherapy cannot be performed for specific reasons; The time elapsed since the completion of radiotherapy for brain metastases shall be no less than 1 months；\n* The test results of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C and syphilis were negative at screening (If hepatitis B core antibody (HBcAb) is positive, additional HBV DNA testing is required, and subjects whose test result is less than the reference value can be included in the study) ;\n* Female patients or male reproductive age patients and their partners should agree to effective contraception from sighing Informed Consent Form (ICF) to 6 months after the last BHP01 infusion.\n\nExclusion Criteria:\n\n* Patients with known primary Central Nervous System (CNS) tumor, or meningeal metastasis, or patients with unstable CNS metastasis (symptomatic, requiring hormonal therapy within 4 weeks before investigational treatment, or no radiographic evidence of stabilization of the lesion for more than 4 weeks);\n* Received major surgical procedures （except for diagnosis） within 4 weeks before PBMCs collection, or are expected to require major surgical procedures during the study;\n* Received Chinese herbal medicine or Chinese patent medicine for anti-tumor indications within 7 days before Peripheral Blood Mononuclear Cells (PBMCs) collection;\n* Patients with a history of idiopathic pulmonary fibrosis, mechanical pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia by chest computer tomography (CT) at screening \\[a history of radiation pneumonia (fibrosis) in the irradiated field may participate in this study\\];\n* Poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage procedures (once a month or more frequently);\n* Poorly controlled or symptomatic hypercalcemia (ionic calcium\\> 1.5 mmol\u002FL, calcium\\> 12 mg\u002FdL or corrected calcium\\> ULN);\n* Presence of active or previous autoimmune diseases or immunodeficiencies, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, etc.;\n* Severe infection within 4 weeks before the start of PBMCs collection, including but not limited to hospitalization due to infection, bacteremia, severe pneumonia, or any active infection that may affect the patient's safety;\n* Serious cardiovascular and cerebrovascular diseases (such as heart disease ≥New York Heart Association class II, myocardial infarction or cerebrovascular accident), unstable arrhythmia or unstable angina pectoris within 3 months before PBMCs collection;\n* Previous treatment with DLL 3 target drugs or CAR-T or other gene-modified T cells;\n* Received any other Investigational drug within 28 days prior to PBMCs collection;\n* A history of mental illness;\n* Incapacitated persons or persons with limited capacity;\n* pregnant or lactating females; Males or females who are unwilling to use adequate contraception; Females of childbearing potential are required to undergo a pregnancy study during the screening period;","70 Years",{"count":117,"type":22},30,[56],"A study to evaluate the safety and feasibility of α-PD-L1\u002F4-1BB DLL3 Chimeric Antigen Receptor (CAR)-T (BHP01) in patients with Relapsed\u002FRefractory Small Cell Lung Cancer (SCLC) and determine the appropriate CAR-T cell dose. Next, In dose expansion phase, patients were assign two groups with\u002Fwithout bridge radiotherapy.",[121],"Small Cell Lung Cancer Extensive Stage",[123,124,125],"Extensive Stage-SCLC","DLL3 CAR-T","Bridge Radiotherapy","2026-07-20",{"date":37,"type":35},{"date":129,"type":35},"2025-04-03",{"date":131,"type":22},"2026-12-31",{"name":41,"class":42},{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":43},"100646242","phase-1-a-phase-ib-study-of-tislelizumab-plus-sys6010-in-immunotherapy-pretreated-locally-advanced-or-metastatic-nsclc-100646242","NCT07692048","A Phase Ib Study of Tislelizumab Plus SYS6010 in Immunotherapy-Pretreated Locally Advanced or Metastatic NSCLC","SYS6010","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\nHave histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.\n\nHave no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.\n\nHave experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:\n\nProgression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or\n\nProgression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or\n\nProgression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or\n\nProgression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).\n\na. Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.\n\nHave at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).\n\nHave an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).\n\nHave a life expectancy of ≥ 3 months as assessed by the investigator.\n\nAgree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.\n\nHave adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):\n\nBone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL; haemoglobin ≥ 90 g\u002FL.\n\nHepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g\u002FL.\n\nRenal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 3).\n\nCoagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nSubjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA \\\u003C 1000 IU\u002FmL and be willing to receive antiviral therapy throughout the study period.\n\nToxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).\n\nSubjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).\n\nSubjects must be able to communicate well with the investigator and comply with protocol-required follow-up.\n\nExclusion Criteria:\n\n* Inclusion Criteria\n\nSubjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\nHave histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not amenable to curative surgery or radiotherapy.\n\nHave no known EGFR mutations, ALK rearrangements, or ROS1 rearrangements.\n\nHave experienced radiographic disease progression per RECIST v1.1 after prior treatment with an anti-PD-(L)1 antibody for locally advanced or metastatic NSCLC, with prior therapy including:\n\nProgression on anti-PD-(L)1 antibody combined with platinum-based chemotherapy (second-line); or\n\nProgression on platinum-based chemotherapy following prior anti-PD-(L)1 monotherapy (third-line); or\n\nProgression on anti-PD-(L)1 monotherapy and considered unfit for platinum-based chemotherapy (second-line); or\n\nProgression on anti-PD-(L)1-containing therapy following prior platinum-based chemotherapy (third-line).\n\na. Adjuvant or neoadjuvant therapy is counted as one prior line of therapy if the time between the last dose of chemotherapy and tumour recurrence is ≤ 6 months.\n\nHave at least one evaluable tumour lesion per RECIST v1.1 (see Appendix 1).\n\nHave an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (see Appendix 2).\n\nHave a life expectancy of ≥ 3 months as assessed by the investigator.\n\nAgree to undergo tumour tissue biopsy before the first study treatment and during the treatment period, whenever clinically feasible.\n\nHave adequate bone marrow, hepatic, renal, and coagulation function confirmed by laboratory tests obtained within 7 days before the first dose (transfusion or growth factor support is not permitted within 2 weeks prior to the screening assessment):\n\nBone marrow function: Absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL; haemoglobin ≥ 90 g\u002FL.\n\nHepatic function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN in the presence of liver metastases); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (or ≤ 5.0 × ULN in the presence of liver metastases); albumin ≥ 28 g\u002FL.\n\nRenal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula; see Appendix 3).\n\nCoagulation function: International normalised ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\nSubjects with chronic hepatitis B virus (HBV) infection must have HBV-DNA \\\u003C 1000 IU\u002FmL and be willing to receive antiviral therapy throughout the study period.\n\nToxicities from prior therapy must have recovered to ≤ Grade 1 (CTCAE v5.0) or to a stable condition per investigator assessment at the time of the first study dose (alopecia and pigmentation excepted).\n\nSubjects of childbearing potential must agree to use highly effective contraceptive methods (including vasectomy, abstinence, etc.; see Appendix 4) throughout the study period (from signing the ICF until 6 months after the last dose of investigational product).\n\nSubjects must be able to communicate well with the investigator and comply with protocol-required follow-up.",{"count":141,"type":22},21,[56],"Introduction: Patients with driver gene-negative non-small cell lung cancer (NSCLC) who experience treatment failure following immune checkpoint inhibitor (ICI) therapy have limited subsequent treatment options, representing an unmet clinical need. EGFR is commonly expressed in EGFR wild-type NSCLC and represents a potential target for therapeutic intervention. Antibody-drug conjugates (ADCs) combine the high targeting specificity of antibodies with the potent cytotoxic effects of payloads. SYS6010 is an EGFR-targeting ADC conjugated to a topoisomerase I inhibitor. Preclinical and clinical studies suggest that the combination of ADCs and ICIs can synergistically enhance anti-tumor efficacy through multiple immunomodulatory mechanisms. Tislelizumab is an approved PD-1 inhibitor for advanced NSCLC. This study aims to evaluate the safety and efficacy of SYS6010 in combination with tislelizumab in patients with driver gene-negative NSCLC who have failed prior PD-1\u002FPD-L1 inhibitor therapy.\n\nMethods: This is an exploratory clinical trial enrolling patients with driver gene-negative NSCLC who have failed prior PD-1 or PD-L1 inhibitor therapy. The primary objective is to evaluate the safety of the combination therapy, with primary endpoints including the incidence, severity, and type of adverse events (AEs) according to NCI-CTCAE v6.0 criteria. Secondary objectives include assessing efficacy (objective response rate \\[ORR\\], disease control rate \\[DCR\\], duration of response \\[DOR\\], progression-free survival \\[PFS\\], overall survival \\[OS\\]) and exploring the association of potential predictive or prognostic biomarkers (e.g., EGFR and PD-L1 expression levels) with response to study treatment.",[145],"NSCLC","NOT_YET_RECRUITING","2026-07-02",{"date":149,"type":35},"2026-07-09",{"date":151,"type":22},"2026-06-30",{"date":74,"type":22},{"name":41,"class":42},{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":172,"leadSponsor":174,"locationsCount":43},"100644182","analysis-of-efficacy-and-outcomes-of-immunotherapy-for-malignant-tumors-a-prospective-non-interventional-clinical-study-100644182","NCT07665697","Analysis of Efficacy and Outcomes of Immunotherapy for Malignant Tumors: A Prospective Non-interventional Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically or cytologically confirmed malignant tumor;\n3. Planned to receive immune checkpoint inhibitor (e.g., PD-1\u002FPD-L1 inhibitor)-based therapy (monotherapy or in combination with chemotherapy\u002Ftargeted therapy\u002Fradiotherapy, etc.);\n4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n5. Adequate organ function (with reference to laboratory tests such as complete blood count, liver and kidney function tests);\n6. Voluntary participation in this study, signed informed consent, and willingness to comply with follow-up.\n\nExclusion Criteria:\n\n1. Active autoimmune disease requiring systemic immunosuppressive therapy (physiological doses of glucocorticoid replacement therapy or inhaled steroids are permitted);\n2. Active, uncontrolled severe infection, or known human immunodeficiency virus (HIV) infection;\n3. Pregnant or breastfeeding women;\n4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).",{"count":161,"type":22},500,"OBSERVATIONAL","The population receiving immunotherapy is heterogeneous. Multiple factors, including combination treatment modalities, influence the immune response, and survival outcomes also vary among individuals receiving immunotherapy. The aim of this study is to develop and validate a clinical prediction model that can predict survival outcomes of immunotherapy for malignant tumors, and to assess the calibration and discrimination of this model in a prospective independent cohort.",[165,166,167],"Neoplasms","Drug Therapy","Immune Checkpoint Inhibitors (ICIs)","2026-06-19",{"date":170,"type":35},"2026-06-24",{"date":151,"type":22},{"date":173,"type":22},"2029-06-15",{"name":41,"class":42},{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":162,"phases":4,"briefSummary":183,"conditions":184,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":188,"leadSponsor":189,"locationsCount":43},"100644128","real-world-study-on-the-efficacy-safety-and-prognostic-factors-of-immune-checkpoint-inhibitors-combined-with-radiotherapy-in-patients-with-malignant-tumors-a-prospective-non-interventional-clinical-study-100644128","NCT07665736","Real-world Study on the Efficacy, Safety, and Prognostic Factors of Immune Checkpoint Inhibitors Combined With Radiotherapy in Patients With Malignant Tumors: A Prospective Non-interventional Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically or cytologically confirmed malignant tumor;\n3. Planned to receive immunotherapy combined with radiotherapy as the basis of treatment;\n4. At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n5. Adequate organ function (reference may be made to laboratory test indicators, such as routine blood tests, liver and kidney function);\n6. Voluntarily participate in this study, sign the informed consent form, and agree to comply with follow-up.\n\nExclusion Criteria:\n\n1. Patients with severe cognitive impairment, mental illness, or other conditions that, in the judgment of the investigator, preclude them from cooperating with participation in this study;\n2. Active, uncontrolled serious infection, or known human immunodeficiency virus (HIV) infection;\n3. Pregnant or breastfeeding women;\n4. Any unstable systemic disease (including but not limited to severe cardiac, hepatic, or renal insufficiency).",{"count":182,"type":22},200,"Currently, chemotherapy, targeted therapy, immunotherapy, and radiotherapy are the core treatment modalities for malignant tumors, with technologies advancing rapidly. Radiotherapy can induce massive tumor cell death in a short period and expose abundant tumor-specific antigens, turning the irradiated tumor into an endogenous tumor vaccine and even causing regression or disappearance of non-irradiated tumors (the abscopal effect) . Preclinical studies have shown that stereotactic body radiotherapy (SBRT) combined with PD-1\u002FPD-L1 inhibitors can activate systemic immunity, sensitize tumor-specific T cells to enter the bloodstream, and enable their homing to distant tumors, thereby inhibiting the growth of non-irradiated tumors . However, conclusions from rigorous randomized controlled trials have limitations when applied to the complex and heterogeneous patient populations in real-world settings. Real-world research is increasingly valued globally to complement traditional clinical trial evidence. This project prospectively collects data from patients receiving immunotherapy combined with radiotherapy in real-world clinical practice, which is of great value for evaluating long-term efficacy, safety, and impact on quality of life, and can provide high-level evidence for optimizing clinical practice and informing healthcare decisions.",[185,167],"Radiotherapy",{"date":170,"type":35},{"date":151,"type":22},{"date":173,"type":22},{"name":41,"class":42},{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":204,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100641511","phase-2-perioperative-fruquintinib-combined-with-sintilimab-and-sox-for-locally-advanced-gastric-or-gej-adenocarcinoma-100641511","NCT07658872","Perioperative Fruquintinib Combined With Sintilimab and SOX for Locally Advanced Gastric or GEJ Adenocarcinoma","Perioperative Fruquintinib Combined With Sintilimab and SOX Versus Sintilimab and SOX for Resectable Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma：A Multicenter,Open-label, Randomized Controlled Phase II Clinical Study","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Histologically confirmed gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Clinically staged as T3-4a N0-3M0 by computed tomography (CT) or magnetic resonance imaging (MRI).\n5. Considered eligible for curative resection.\n6. No prior antitumor therapy for the current disease.\n7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.\n8. Expected survival of ≥6 months.\n\nExclusion Criteria:\n\n1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.\n2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.\n3. Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.\n4. History of thromboembolic or arterial\u002Fvenous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.\n5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.",{"count":198,"type":22},120,[88],"The purpose of this clinical trial is to evaluate whether perioperative fruquintinib combined with sintilimab and SOX is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.\n\nPrimary Objective:\n\nTo determine whether perioperative fruquintinib combined with sintilimab and SOX improves the pathological complete response (pCR) rate compared with sintilimab plus SOX in patients with locally advanced gastric or GEJ adenocarcinoma.\n\nStudy Design:\n\nParticipants will be randomly assigned to receive either fruquintinib combined with sintilimab and SOX or sintilimab plus SOX to evaluate the potential added benefit of fruquintinib in this setting.\n\nParticipation Details:\n\nParticipants will receive the assigned treatment (fruquintinib combined with sintilimab and SOX or sintilimab plus SOX) every 21 days for approximately 3 months.\n\nThey will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.\n\nParticipants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.",[202,203],"Gastric Adenocarcinoma","Esophagogastric Junction Adenocarcinoma",[205,206,207],"Gastric Cancer","neoadjuvant treatment","Fruquintinib","2026-06-15",{"date":210,"type":35},"2026-06-22",{"date":208,"type":22},{"date":213,"type":22},"2028-04-06",{"name":41,"class":42},{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":4,"eligibilityCriteria":221,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":43},"100643738","phase-1-peptide-nanovaccine-onvax-01-plus-anti-pd-1-antibody-and-chemotherapy-in-advanced-pancreatic-cancer-100643738","NCT07637786","Peptide Nanovaccine (ONVAX-01) Plus Anti-PD-1 Antibody and Chemotherapy in Advanced Pancreatic Cancer","An Exploratory Clinical Study of Peptide Nanovaccine (ONVAX-01) and Anti-PD-1 Antibody Combined With Chemotherapy for the Treatment of Advanced Pancreatic Cancer","Inclusion Criteria:\n\n* • Age between 18 and 75 years (inclusive).\n\n  * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Histologically confirmed, KRAS-mutated, unresectable metastatic pancreatic ductal adenocarcinoma (PDAC).\n  * Documented disease progression after at least one prior line of systemic therapy.\n  * Estimated life expectancy of ≥ 12 weeks.\n  * At least one measurable objective tumor lesion according to RECIST v1.1. The maximum diameter must be ≥ 1 cm by spiral CT, or ≥ 2 cm by standard CT or MRI; imaging must be performed within 28 days prior to enrollment.\n  * Adequate bone marrow and organ function, defined as follows (without the use of hematopoietic growth factors or blood transfusions within 7 days prior to testing):\n\n    * Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL, platelet count ≥ 75 × 10\\^9\u002FL, and hemoglobin ≥ 90 g\u002FL.\n    * Hepatic: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n    * Renal: Creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n    * Coagulation: International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN.\n    * Cardiac: Normal electrocardiogram (ECG) or abnormal ECG deemed clinically insignificant by the investigator.\n    * Urinalysis: Urine protein \\\u003C 2+; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be \\\u003C 1.0 g.\n  * Participants of childbearing potential must agree to use highly effective contraceptive measures from study entry throughout the study period.\n  * Participants with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection must have received at least 14 days of continuous antiviral therapy prior to the first study dose. HBV DNA titer must be ≤ 500 IU\u002FmL (or 2500 copies\u002FmL) and HCV RNA must be below the lower limit of detection. Participants must be willing to continue effective antiviral therapy during the study.\n\nExclusion Criteria:\n\n* • Receipt of anti-tumor chemotherapy, radiotherapy, or immunotherapy within 2 weeks prior to the first dose of the study vaccine.\n\n  * History of other malignancies, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, non-muscle invasive bladder cancer (Ta and TIS), or other malignancies curatively treated at least 5 years prior to enrollment.\n  * Uncontrolled concomitant diseases, including but not limited to active bacterial or fungal infections, symptomatic congestive heart failure, unstable angina, or cardiac arrhythmias.\n  * Prior treatment with any antibody or drug targeting T-cell co-regulatory proteins (immune checkpoints), such as anti-PD-1, anti-PD-L1, anti-CTLA-4, anti-OX-40, anti-CD137, anti-TIM-3, or anti-LAG-3 antibodies.\n  * Human Immunodeficiency Virus (HIV) infection, or active uncontrolled HBV (HBV DNA ≥ 500 IU\u002FmL) or HCV infection.\n  * Uncontrolled coronary artery disease, asthma, cerebrovascular disease, or any other medical conditions deemed unsuitable for enrollment by the investigator.\n  * Active autoimmune disease, primary or secondary immunodeficiency, or current treatment with immunosuppressive medications.\n  * Pregnant or lactating women.\n  * Receipt of any prophylactic vaccines for infectious diseases within 4 weeks prior to the first dose, or planned vaccination during the study up to 8 weeks after the last dose.\n  * History of severe allergic reactions to prior prophylactic vaccines.\n  * Known allergy or hypersensitivity to the investigational drugs or any of their excipients.\n  * History of substance abuse, or any clinical, psychological, or social factors that would preclude the administration of immunotherapy.\n  * Significant weight loss (≥ 10% of body weight) within 6 weeks prior to enrollment.\n  * Any other condition or uncertainty that, in the investigator's judgment, could compromise patient safety or compliance with the study protocol.",{"count":223,"type":22},9,[56],"The goal of this clinical trial is to evaluate the safety and preliminary effectiveness of a new combination therapy in patients with advanced pancreatic cancer.\n\nThe main questions it aims to answer are:\n\n1. Is the combination of the peptide nanovaccine (ONVAX-01), an anti-PD-1 antibody, and chemotherapy safe and well-tolerated?\n2. Does this combination treatment help shrink tumors or stop the progression of advanced pancreatic cancer?\n\nParticipants will be asked to:\n\n1. Receive doses of the peptide nanovaccine (ONVAX-01).\n2. Receive intravenous infusions of an anti-PD-1 antibody and standard chemotherapy.\n3. Undergo regular physical exams, blood tests, and imaging scans (such as CT or MRI) to monitor their health and the tumor's response to the treatment.",[227],"Advanced Pancreatic Adenocarcinoma",[229,230,231,232],"Advanced pancreatic adenocarcinoma","Anti-PD-1 Antibody","Peptide Nanovaccine","Chemotherapy","2026-06-09",{"date":235,"type":35},"2026-06-10",{"date":237,"type":22},"2026-06-20",{"date":239,"type":22},"2029-09-01",{"name":41,"class":42},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":248,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":43},"100612789","phase-2-safety-and-efficacy-of-radiotherapy-combined-with-immunochemotherapy-in-pre-treated-sclc-patients-with-liver-metastases-100612789","NCT07258147","Safety and Efficacy of Radiotherapy Combined With Immunochemotherapy in Pre-treated SCLC Patients With Liver Metastases","Clinical Study on the Efficacy and Safety of Radiotherapy Combined With Immunotherapy and Chemotherapy for Pre-treated Patients With Small Cell Lung Cancer and Liver Metastases","Inclusion Criteria:\n\n1. Aged 18 to 75 years, with an ECOG Performance Status of 0-2.\n2. Histologically confirmed stage IV non-small cell lung cancer (NSCLC) or extensive-stage small cell lung cancer, with radiologically confirmed liver metastases (at least one measurable lesion with the longest diameter ≥ 1 cm).\n3. Prior failure (due to progression or intolerance) to platinum-based doublet chemotherapy and PD-1\u002FPD-L1 inhibitor therapy.\n4. Adequate liver function reserve (Child-Pugh class A or B, ALT\u002FAST ≤ 5 × ULN, total bilirubin ≤ 1.5 × ULN).\n5. Life expectancy of at least 3 months.\n6. Normal function of major organs and no severe dysfunction of the hematopoietic, cardiac, pulmonary, hepatic, renal, or bone marrow systems, or immunodeficiency diseases.\n7. Within one week prior to enrollment, bone marrow and organ function meet the following criteria:Hemoglobin ≥ 80 g\u002FL, neutrophil count ≥ 1.5 × 10⁹\u002FL, and platelet count ≥ 70 × 10⁹\u002FL. Renal function: Serum creatinine ≤ 1.5 × ULN, and endogenous creatinine clearance rate ≥ 55 ml\u002Fmin.Liver function: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (if liver metastases are present, total bilirubin ≤ 3 × ULN and transaminases ≤ 5 × ULN are acceptable).\n8. Voluntarily participates and provides written informed consent.\n9. Good compliance and willingness to adhere to the study visit schedule and other protocol requirements.\n10. Willingness to provide blood and tissue samples for biomarker testing.\n11. Judged by the radiation oncologist to have no contraindications to liver radiotherapy. Patients who agree to receive immunotherapy, chemotherapy, and radiotherapy.\n12. For patients of childbearing potential: agreement to use effective contraception during the study period and for at least 6 months after the last study treatment; negative serum or urine pregnancy test within 7 days prior to study entry; and not breastfeeding. Male patients with partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.\n\nExclusion Criteria:\n\n1. Presence of any active autoimmune disease or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \\[may be included if controlled with hormone replacement therapy\\]); prior liver radiotherapy or liver transplantation; history of liver cirrhosis (Fibroscan ≥ F3), portal hypertension, or hepatic encephalopathy.\n2. Congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU\u002Fml), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay), or co-infection with both hepatitis B and C.\n3. Uncontrolled or significant cardiac disease, including: (a) NYHA Class II or higher heart failure; (b) Unstable angina; (c) Myocardial infarction within the past 1 year; (d) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n4. Severe infection or serious comorbidities within 4 weeks prior to the first dose of study treatment.\n5. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n6. History of other primary malignancies within the past 5 years.\n7. Known allergy to any of the trial drugs or their excipients.\n8. Pregnant or lactating women, or subjects of childbearing potential unwilling to use effective contraception during the study period.\n9. Patients with Child-Pugh class B or C liver insufficiency.\n10. Any other contraindication as determined by the investigator to preclude participation in the study.",{"count":117,"type":22},[88],"This is clinical trial evaluating the safety and efficacy of radiotherapy combined with immunotherapy and chemotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) and liver metastases.",[252],"Lung Cancer (SCLC)",[254,185,255,232],"SCLC","Immunotherapy","2026-05-04",{"date":258,"type":35},"2026-05-05",{"date":260,"type":22},"2026-10-31",{"date":105,"type":22},{"name":41,"class":42},{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":270,"targetDuration":4,"studyType":23,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":282,"locationsCount":43},"100549259","phase-1-safety-and-efficacy-of-whole-brain-ldrticiintrathecal-chemotherapy-in-refractory-meningeal-metastasis-of-lung-cancer-100549259","NCT06431685","Safety and Efficacy of Whole Brain LDRT+ICI+Intrathecal Chemotherapy in Refractory Meningeal Metastasis of Lung Cancer","Phase I Study of Whole Brain Low Dose Radiotherapy Combined With ICI and Intrathecal Chemotherapy for Treatment of Refractory Meningeal Metastasis of Lung Cancer","Inclusion Criteria:\n\n1. ≥ 18 years old and ≤ 75 years old;\n2. Patients with a definite diagnosis of leptomeningeal metastasis by cerebrospinal fluid cytology, or patients with clinical diagnosis combined with tumor history, neuroimaging, clinical manifestations, cerebrospinal fluid examination, etc.;\n3. Patients with a clear history of lung carcinoma, including histopathological diagnosis or a combination of cytopathology and imaging, and failure of standard treatment;\n4. Efficacy of extracranial lesions SD;\n5. Patients with no contraindications to craniocranial radiotherapy were judged by radiotherapy doctors. Subjects who agree to receive immunotherapy, Lumbar puncture, intrathecal chemotherapy, and radiotherapy;\n6. Expected survival ≥3 months, PS score ≤3;\n7. Agree to provide cerebrospinal fluid, blood and tissue samples for biomarker testing;\n8. The main organs function normally, no serious blood, heart, lung, liver, kidney, bone marrow and other functional abnormalities and immune deficiency diseases;\n9. One week before enrollment, bone marrow and liver and kidney function met the following criteria:\n\n   ① Hemoglobin ≥80 g\u002FL, neutrophils ≥1.5×10\\^9\u002FL and platelets ≥70×10\\^9\u002FL;\n\n   ② Renal function: Cr≤ULN (upper limit of normal) × 1.5, endogenous creatinine clearance (Ccr)≥55 ml\u002Fmin; Liver function: total bilirubin ≤ULN × 1.5; ALT, AST≤ULN × 2.5; (In case of liver metastasis, total bilirubin should not be higher than 3 times the upper normal limit, and transaminase should not be higher than 5 times the upper normal limit);\n10. The fertile women agreed to use contraception during the study period and for 6 months after the study ended; Patients who tested negative for a serum or urine pregnancy test within 7 days prior to joining the study and were not breastfed; Men who agreed to use contraception during the study period and for 6 months after the study ended\n\nExclusion Criteria:\n\n1. Active autoimmune disease or history of autoimmune diseases;\n2. Congenital or acquired immunodeficiency;\n3. Uncontrolled cardiac clinical symptoms or diseases;\n4. Severe infection or severe comorbidities, such as bleeding peptic ulcer, ileus, heart failure, renal failure, or poorly controlled diabetes;\n5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;\n6. Other systemic malignancies within the last 5 years;\n7. Allergy to any test drug;\n8. Uncontrolled epilepsy, neurological failure, or severe treatment-related neurological impairment, uncontrollable psychosis, and other conditions deemed unsuitable for inclusion by the investigator;\n9. Pregnant and lactating women, subjects with reproductive capacity are unwilling to take effective contraceptive measures.",{"count":21,"type":22},[56],"This phase I study aims to investigate the safety and efficacy of whole brain low dose radiotherapy (WB-LDRT) combined with ICI and intrathecal chemotherapy for treatment of refractory meningeal metastasis of lung cancer.",[145,274,275,276],"Low Dose Radiotherapy","PD-1 Inhibitor","Leptomeningeal Metastasis",{"date":278,"type":35},"2026-05-08",{"date":280,"type":35},"2024-04-25",{"date":131,"type":22},{"name":41,"class":42},{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":291,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":304,"locationsCount":43},"100531084","phase-1-sunvozertinib-combined-with-chemotherapy-for-egfrm-after-egfr-tki-treatment-failurephase-iii-100531084","NCT06195189","Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I\u002FII","Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure：Phase I\u002FII (WU-KONG36)","WU-KONG36","Inclusion Criteria:\n\n1. To provide a signed and dated, written informed consent.\n2. 80≥Age ≥ 18 years old\n3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory\n4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.\n5. Predicted life expectancy ≥ 12 weeks\n6. EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.\n7. No previous systemic chemotherapy for advanced or metastatic disease.\n8. Adequate organ system function:\n9. Patient must have measurable disease according to RECIST 1.1.\n10. Patients with stable or pre-treated brain metastasis (BM) can be enrolled\n\nExclusion Criteria:\n\n1. Spinal cord compression or meningeal metastasis\n2. A history of malignant tumors within 2 years.\n3. With known resistant mutations that have approved target therapy\n4. Recover from AEs caused by previous treatment\n5. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.\n6. Any severe or poorly controlled systemic disease per investigator's judgment active infections, including but not limited to hepatitis B (HBV), hepatitis C (HCV), and human immunodeficiency (HIV)",{"count":54,"type":22},[56,88],"To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.",[295],"Non Small Cell Lung Cancer",[295,297,298,299],"Sunvozertinib","EGFR","chemotherapy",{"date":278,"type":35},{"date":302,"type":35},"2024-02-29",{"date":105,"type":22},{"name":41,"class":42},{"id":306,"slug":307,"hasResults":12,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":312,"targetDuration":4,"studyType":23,"phases":314,"briefSummary":315,"conditions":316,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":43},"100532818","phase-1-safety-and-tolerability-of-ldrtsugemalimabchemotherapyolaparib-for-first-line-treatment-of-slfn-11-positive-es-sclc-100532818","NCT06217757","Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC","Phase I Study of Low-Dose Radiotherapy Plus Chemotherapy and Sugemalimab and Olaparib for First-Line Treatment of SLFN-11 Positive Extensive Stage Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Men or women aged more than or equal to (≥) 18 years old and less than or equal to (≤) 75 years old\n2. Histologically or cytologically confirmed ES-SCLC\n3. No prior treatment for ES-SCLC\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n5. Five white slides (unstained paraffin sections) were available for immunohistochemical SLFN-11 detection and SLFN-11 was positive\n6. Extensive clinical stage. American Joint Committee on Cancer (AJCC) 8th edition Stage IV with lesions exceeding one side of the chest and including malignant pleural and pericardial effusions or hematogenous metastases (any T, any N, M1a\u002Fb\u002Fc); or T3-4 due to multiple nodules in the lung or tumor\u002Fnodule size too large to be included in a T3-4 disease within a tolerable radiotherapy schedule\n7. The subjects were considered suitable for combining etoposide with cisplatin chemotherapy and low-dose radiotherapy as first-line treatment for extensive -stage small cell lung cancer\n8. Have measurable lesions as defined by RECIST1.1, with at least one lesion (never previously treated with radiation) of ≥10 mm longest diameter accurately measured by computed tomography (CT) or magnetic resonance imaging (MRI) at baseline (except for lymph nodes, which must have a short axis of ≥15 mm) and the lesion is suitable for repeat and accurate measurements\n9. Patients with brain metastases must be asymptomatic or stable on steroids and anticonvulsants for at least 1 month prior to study treatment. Participants with suspected brain metastases during screening should have a CT\u002FMRI of the brain prior to study\n10. No previous treatment with immune checkpoint inhibitors and PARP inhibitors, including but not limited to other anti-PD-1, anti-PD-L1 and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, with the exception of therapeutic anti-tumor vaccines. No prior chemotherapy or radiation therapy to the chest lesion\n11. Weight over 30 Kg\n12. Life expectancy ≥ 12 weeks\n13. Have adequate organ and bone marrow functional reserve and normal major organ function\n14. Patients were compliant, voluntarily enrolled in the study and signed an informed consent form\n15. For women or men with childbearing potential: use effective contraception to avoid conception or embryonic drug exposure during treatment and for 5 months after the last dose of sugemalimab and for 6 months after the last dose of cisplatin or etoposide. Female subjects are prohibited from donating eggs during this period and males are prohibited from donating sperm during this period\n\nExclusion Criteria:\n\n1. Histopathologic or cytopathologic diagnosis of mixed small cell lung cancer or non-small cell lung cancer\n2. Limited stage small cell lung cancer\n3. Combination of poorly controlled malignant pleural or pericardial effusions requiring continuous drainage\n4. Presence of active or symptomatic brain metastases or Leptomeningeal metastases\n5. Prior systemic antitumor therapy (chemotherapy, targeted agents such as PARP inhibitors) or immune checkpoint inhibitors for SCLC\n6. Presence of active, unstable systemic disease such as active infection, autoimmune disease, inflammatory disease (uncontrolled hypertension, heart failure (NYHA classification \\>= Class II), unstable angina, acute coronary syndrome, severe arrhythmia, severe hepatic, renal or metabolic disease, human immunodeficiency virus (HIV) immunodeficiency virus (HIV) infected patients\n7. Previous allogeneic stem cell or solid organ transplantation\n8. Patients with prior interstitial lung disease, drug-induced interstitial lung disease, or active interstitial pneumonia requiring systemic glucocorticoid or immunosuppressive therapy; Patients with pulmonary interstitial fibrosis or active pulmonary tuberculosis\n9. Severe infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia\n10. Received therapeutic oral or intravenous infusion of antibiotics within 2 weeks prior to the start of study treatment\n11. Been diagnosed or treated for another malignancy (excluding resected basal cell carcinoma of the skin or other carcinoma in situ) within 5 years prior to randomization to this study\n12. For pregnant or lactating females or male or female subjects of reproductive potential who refuse to use effective contraception during treatment and within 5 months of the last dose of sugemalimab and within 6 months of the last dose of cisplatin or etoposide\n13. Allergic to the study drug or its components\n14. The investigator believes that the patients may not be able to complete the study or comply with the requirements of the study\n15. Inadequate bone marrow function and vital organ function reserve\n16. Concurrent participation in another clinical study, unless it is an observational (non-interventional) clinical study or a follow-up phase of an interventional study, excluding patients who have received any other experimental drug within 28 days prior to the start of study treatment\n17. Patients who are not suitable for etoposide-cisplatin chemotherapy, sugemalimab or olaparib\n18. History of thoracic radiotherapy or plan to receive intensive thoracic radiotherapy prior to systemic therapy. External chest radiotherapy for palliative purposes (e.g., bone metastases) is allowed, but must be completed prior to the first administration of study drug",{"count":313,"type":22},45,[56,88],"The purpose of this study was to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) combined with sugemalimab, olaparib, chemotherapy in the first-line treatment of SLFN-11 positive extensive stage small cell lung cancer.",[317,318],"Lung Cancer","Extensive-stage Small-cell Lung Cancer","2026-04-29",{"date":258,"type":35},{"date":322,"type":35},"2024-04-18",{"date":324,"type":22},"2028-10-31",{"name":41,"class":42},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":23,"phases":335,"briefSummary":336,"conditions":337,"keywords":339,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":346,"leadSponsor":348,"locationsCount":43},"100542974","phase-1-safety-and-tolerability-of-ldrt-plus-concurrent-partial-sbrt-and-tislelizumab-in-patients-with-bulky-tumors-100542974","NCT06349837","Safety and Tolerability of LDRT Plus Concurrent Partial SBRT and Tislelizumab in Patients With Bulky Tumors","Safety and Tolerability of Low Dose Radiotherapy Plus Concurrent Partial Stereotactic Ablative Radiotherapy (Eclipse-RT) and Tislelizumab in Patients With Bulky Tumors","Inclusion Criteria:\n\n1. Be willing and able to provide written informed consent\u002Fassent for the trial.\n2. Be ≥18 years of age on day of signing informed consent.\n3. Patients with histologically or cytologically confirmed stage IV solid tumours.\n4. Be willing to undergo repeat biopsy of tumor lesions according to the study protocol.\n5. Patients who have failed the standard therapy, or who are unsuitable for standard treatment, or refuse chemotherapy.\n6. At least one measurable lesion according to RECIST 1.1. A lesion that has previously received radiotherapy can be considered a target lesion only if this lesion is clearly progressed after radiotherapy.\n7. The target lesions (irradiated lesions) are \\> 5cm in in diameter\n8. ECOG 0-2.\n9. Life expectancy of \\> 3 months.\n10. Subjects should agree to use an adequate method of contraception.\n\nExclusion Criteria:\n\n1. Has known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis and\u002For spinal cord compression, etc.\n2. With oncologic emergencies that require immediate treatment\n3. EGFR\u002FALK\u002FROS-1 mutation or mutation status unknown.\n4. Has evidence of interstitial lung disease or active and\u002For non-infectious pneumonitis (drug-induced pneumonia, radiation-induced pneumonia, etc.) requiring steroid therapy.\n5. History of pulmonary fibrosis, pulmonary hypertension, severe irreversible airway obstruction disease\n6. Patients with peripheral neuropathy.\n7. Significant heart disease or impairment of cardiac function\n8. Fluid accumulating in the third space, such as pericardial effusion, pleural effusion and peritoneal effusion that remains uncontrolled by aspiration or other treatment\n9. Known allergy to drugs or excipients, known severe allergic reaction to any of the PD-1 monoclonal antibodies\n10. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.",{"count":334,"type":22},24,[56],"This is a 3+3 dose escalation phase I study which aims to evaluate the safety and tolerability of low dose radiotherapy (LDRT) plus concurrent partial Stereotactic Ablative Radiotherapy (SBRT) and Tislelizumab in Patients with bulky tumors who have failed standard therapy. At least 9 participants will be enrolled in this study.",[338],"Solid Tumor",[274,340,341],"Stereotactic Ablative Radiotherapy","Tislelizumab","2026-04-27",{"date":344,"type":35},"2026-05-01",{"date":322,"type":35},{"date":347,"type":22},"2028-11-30",{"name":41,"class":42},{"id":350,"slug":351,"hasResults":12,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":355,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":357,"targetDuration":4,"studyType":23,"phases":359,"briefSummary":360,"conditions":361,"keywords":364,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":43},"100632884","phase-2-intensive-nutritional-support-in-conversion-therapy-for-locally-advanced-unresectable-escc-100632884","NCT07519486","Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable ESCC","A Prospective Randomized Controlled Clinical Trial of Intensive Nutritional Support in Conversion Therapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma","INS-ESCC-CT","Inclusion Criteria:\n\nPathologically confirmed Esophageal Squamous Cell Carcinoma (ESCC). Aged 18-80 years, regardless of gender. ECOG Performance Status (PS) 0-2, and weight loss \\\u003C 10% within the past 6 months.\n\nConfirmed locally advanced unresectable ESCC according to NCCN Guidelines (Version 2026.1).\n\nPlanned to receive surgery after completion of conversion therapy, with no surgical contraindications.\n\nTreatment-naive: No prior anti-tumor therapy for ESCC, including radiotherapy, chemotherapy, or surgery.\n\nPresence of measurable lesion(s) according to RECIST 1.1. Expected survival ≥ 3 months. Able to swallow and tolerate oral medications. Adequate organ function (blood counts, biochemistry, and coagulation parameters meeting protocol requirements).\n\nWomen of childbearing age and men must agree to use effective contraception during the study and for 6 months after completion.\n\nVoluntary participation with signed informed consent and good compliance.\n\nExclusion Criteria:\n\nPresence of esophageal-mediastinal fistula and\u002For tracheoesophageal fistula, or tumor invasion of major vessels with risk of fatal hemorrhage.\n\nHistory of other malignant tumors within the past 5 years. Current or prior use of immunosuppressants or systemic steroids (\\>10 mg\u002Fday prednisone equivalent) within 2 weeks prior to first dose.\n\nActive autoimmune disease or history of autoimmune disease requiring systemic treatment.\n\nKnown immunodeficiency history, including HIV infection, organ transplant, or bone marrow transplant.\n\nUncontrolled concurrent diseases (e.g., uncontrolled hypertension, unstable angina, recent myocardial infarction, or severe infections).\n\nActive tuberculosis (TB) or history of TB without standardized treatment. Active Hepatitis B (HBV) or Hepatitis C (HCV) infection. Complete inability to take oral enteral nutrition due to esophageal stenosis. History or current presence of interstitial pneumonia or interstitial lung disease.\n\nUncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n\nSignificant gastrointestinal disorders with severe diarrhea (CTCAE \\> Grade 2). Pregnant or lactating women. Participation in other clinical trials within 30 days prior to enrollment.",{"count":358,"type":22},118,[88],"Malnutrition is highly prevalent in patients with upper gastrointestinal tumors, which may negatively impact treatment tolerance and anti-tumor immune responses. This study aims to evaluate the efficacy and safety of intensive enteral nutritional support in patients with locally advanced unresectable esophageal squamous cell carcinoma (ESCC) undergoing conversion therapy. Participants receiving PD-1 inhibitors combined with chemotherapy will be randomly assigned to either intensive nutritional support or standard care. The primary goal is to determine if intensive nutritional support can improve the pathological complete response (pCR) rate after subsequent surgery.",[362,363],"Esophageal Squamous Cell Carcinoma","Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma",[365,366,367],"Esophageal Neoplasms","Nutritional Support","Neoadjuvant Therapy","2026-04-10",{"date":370,"type":35},"2026-04-15",{"date":372,"type":22},"2026-04",{"date":374,"type":22},"2028-03",{"name":41,"class":42},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":384,"targetDuration":4,"studyType":23,"phases":386,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":399,"locationsCount":43},"100631476","phase-2-sacituzumab-tirumotecan-in-combination-with-anlotinib-in-previously-treated-patients-with-extensive-stage-small-cell-lung-cancer-es-sclc-100631476","NCT07501169","Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC)","Sacituzumab Tirumotecan in Combination With Anlotinib in Previously Treated Patients With Extensive-Stage Small Cell Lung Cancer (ES-SCLC): A Prospective, Single-Arm, Phase II Study (STAR-01)","STAR-01","Inclusion Criteria:\n\n* 1.Voluntary participation with written informed consent obtained prior to any study-specific procedures.\n* 2.Age ≥ 18 years and ≤ 75 years, regardless of sex.\n* 3.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* 4.Life expectancy of at least 3 months.\n* 5.Histologically or cytologically confirmed small cell lung cancer (SCLC) based on pathology and immunohistochemistry\u002Fimmunophenotyping results; disease staged as extensive-stage SCLC (ES-SCLC) according to the Veterans Administration Lung Study Group (VALG) staging system.\n* 6.Disease progression (at the time of enrollment) after at least two cycles of platinum-based systemic therapy with or without PD-1\u002FL1 inhibitors; no more than two prior lines of therapy.\n\nNote: Adjuvant therapy is considered one prior line if disease progression occurs during treatment or within 6 months of the last adjuvant dose.\n\n* 7.At least one measurable lesion as defined by RECIST version 1.1. Lesions previously treated with local therapy may be considered target lesions only if progression has been clearly documented at that site post-treatment. Brain lesions as sole target lesions are not acceptable.\n* 8.Adequate bone marrow function without transfusion or growth factor support within 14 days prior to screening: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 90 g\u002FL.\n* 9.Adequate hepatic function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), or ≤ 2 × ULN for patients with Gilbert's syndrome; TBIL ≤ 3.0 × ULN is permitted if direct bilirubin suggests extrahepatic obstruction. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases).\n* 10.Adequate renal function: Creatinine (Cr) ≤ 1.5 × ULN and creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula or other clinically validated method).\n* 11.Adequate coagulation function: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) ≤ 1.5 × ULN;\n* 12.Adequate cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50% assessed by echocardiography within 28 days prior to enrollment. New York Heart Association (NYHA) classification \\\u003C 3.\n* 13.Female patients of childbearing potential must agree to use medically effective contraception from the time of signing informed consent until 6 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* 1.History of other primary malignancies within 5 years prior to signing informed consent, except for: radically treated malignancies with no recurrence within 5 years; adequately treated non-melanoma skin cancer, cervical carcinoma in situ, thyroid cancer, or other malignancies considered cured.\n* 2.Prior pathological diagnosis of combined small cell lung cancer (e.g., mixed SCLC and NSCLC), transformed NSCLC (SCLC transformed to NSCLC), or transformed SCLC (NSCLC transformed to SCLC).\n* 3.Prior anti-tumor therapy within specified washout periods before first study dose: chemotherapy, radiotherapy, biologics, endocrine therapy, immunotherapy within 4 weeks; topical anti-tumor agents within 5 half-lives; nitrosoureas or mitomycin C within 6 weeks; oral fluoropyrimidines or small-molecule targeted agents within 5 half-lives; anti-tumor traditional Chinese medicine within 2 weeks.\n* 4.Treatment with any other investigational drug or therapy within 4 weeks prior to first study dose.\n* 5.Prior or current use of topoisomerase I inhibitors, including antibody-drug conjugates with topoisomerase I inhibitor payloads (e.g., topotecan, irinotecan, trastuzumab deruxtecan, sacituzumab govitecan, datopotamab deruxtecan \\[DS-1062\\]).\n* 6.Brain metastases unless asymptomatic (stable for ≥4 weeks, requiring ≤10 mg\u002Fday prednisone or equivalent for ≥14 days prior to first dose, and no significant peritumoral edema on imaging); leptomeningeal or brainstem metastases; spinal cord compression (radiographically confirmed, symptomatic or asymptomatic); bone marrow metastases.\n* 7.Imaging evidence of tumor lesions located ≤5 mm from major blood vessels, invading major vessels, or assessed by the investigator as having high risk of major bleeding during the study.\n* 8.History of deep vein or arterial thromboembolic events within 6 months (e.g., cerebrovascular accident including TIA, deep vein thrombosis, pulmonary embolism); DVT adequately treated or superficial vein thrombosis with low bleeding risk per investigator may be enrolled.\n* 9.Prior treatment-related toxicities (CTCAE v5.0) ≥ Grade 2, except for alopecia, residual neurotoxicity, or stable hypothyroidism on hormone replacement.\n* 10.Major surgery (excluding biopsy or vascular access) or significant trauma within 4 weeks prior to first study dose, or planned elective surgery during the study period.\n* 11.Receipt of live or live-attenuated vaccines within 4 weeks prior to first study dose.\n* 12.Systemic corticosteroids (prednisone \\>10 mg\u002Fday or equivalent) or other immunosuppressive agents within 14 days prior to first study dose, except for: topical, ocular, intra-articular, intranasal, or inhaled corticosteroids; short-term corticosteroids for prophylaxis (e.g., contrast allergy).\n* 13.History of non-infectious interstitial lung disease\u002Fpneumonitis requiring steroid maintenance (requiring 14-day washout), current ILD, or suspected ILD not ruled out by imaging at screening.\n* 14.Active tuberculosis; active or uncontrolled autoimmune disease; acquired or congenital immunodeficiency disorders; history of allogeneic stem cell, bone marrow, or solid organ transplantation.\n* 15.Serious infection within 4 weeks prior to first study dose, including but not limited to infection requiring systemic antibiotics, bacteremia, or severe pneumonia.\n* 16.Positive serology results: HIV antibody positive; untreated active hepatitis B (HBsAg positive with HBV-DNA \\> ULN); Note: Patients meeting certain criteria may be enrolled with antiviral prophylaxis\u002Fmonitoring; HCV-Ab positive with detectable HCV-RNA.\n* 17.Significant cardiovascular disease history, including but not limited to: severe cardiac arrhythmia or conduction abnormalities (e.g., requiring intervention, Mobitz II or third-degree AV block); QTcF \\>450 ms (male) or \\>470 ms (female); congestive heart failure (NYHA class ≥II), unstable angina, acute coronary syndrome, aortic dissection, stroke or TIA within 6 months; deep vein thrombosis or pulmonary embolism within 6 months (excluding catheter-related or superficial thrombosis); uncontrolled hypertension (systolic \\>160 mmHg and\u002For diastolic \\>100 mmHg).\n* 18.Clinically uncontrolled third-space fluid collections (e.g., pleural or ascitic effusion requiring intervention; patients with stable effusions \\>1 week post-drainage may enroll); pericardial effusion (asymptomatic minimal effusion not requiring intervention may enroll). If intra-cavity anti-tumor agents were used, a washout of ≥5 half-lives or 4 weeks (whichever is shorter) is required.\n* 19.Known hypersensitivity or delayed allergic reaction to any component of the study drugs or comparators (e.g., topotecan, irinotecan, paclitaxel monotherapy).\n* 20.Substance abuse, alcohol\u002Fdrug dependence, or any medical condition (e.g., anxiety, depression) that may interfere with study participation or outcomes per investigator judgment.\n* 21.Pregnant or breastfeeding women; men or women planning to conceive during the study.\n* 22.Expected poor compliance, or any other severe systemic disease or condition that, in the investigator's opinion, makes the patient unsuitable for this study.\n* 23.Bleeding diathesis (e.g., active peptic ulcer) or requirement for anticoagulants\u002Fvitamin K antagonists (e.g., warfarin, heparin); low-dose prophylactic warfarin (≤1 mg\u002Fd), heparin (≤12,000 U\u002Fd), or aspirin (≤100 mg\u002Fd) permitted if INR ≤1.5. Imaging evidence of tumor invasion, significant necrosis, or cavitation with high bleeding risk per investigator.\n* 24.Any severe or uncontrolled systemic disease, including but not limited to: active tuberculosis\u002Fpulmonary fibrosis; active or uncontrolled infection requiring systemic therapy; clinically active diverticulitis, intra-abdominal abscess, GI obstruction; liver disease (e.g., cirrhosis, decompensated liver disease, acute\u002Fchronic hepatitis); poorly controlled diabetes (two consecutive FBG \\>10 mmol\u002FL); urine protein ≥2+ confirmed by 24-hour urine protein \\>1.0 g; uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium or \\>12 mg\u002FdL calcium or corrected serum calcium \\>ULN) or symptomatic hypercalcemia requiring bisphosphonates; non-healing wounds or fractures; psychiatric disorders interfering with treatment compliance.\n* 25.Factors affecting oral drug absorption (e.g., inability to swallow, post-, chronic diarrhea, intestinal obstruction).\n* 26.Documented severe dry eye syndrome, severe meibomian gland disease and\u002For blepharitis, or history of corneal disease affecting\u002Fdelaying corneal healing.\n* 27.Any other condition deemed unsuitable for participation by the investigator.",{"count":385,"type":22},33,[88],"This is an single-arm, multicenter phase II study to evaluate the safety and efficacy of Sacituzumab Tirumotecan (sac-TMT) plus anlotinib in previously treated extensive-stage small cell lung cancer (ES-SCLC). The study is expected to enroll up to 33 eligible patients.",[389],"Extensive-stage Small Cell Lung Cancer (ES-SCLC)",[254,391,392],"Trop2-ADC","Anlotinib","2026-04-08",{"date":395,"type":35},"2026-04-13",{"date":397,"type":22},"2026-04-01",{"date":74,"type":22},{"name":41,"class":42},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":412,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":43},"100563020","phase-2-multicenter-phase-ii-randomized-controlled-study-of-adebrelimab-combined-with-chemotherapy-and-concurrent-low-dose-radiotherapy-ldrt-for-the-treatment-of-extensive-stage-small-cell-lung-cancer-sclc-100563020","NCT06610734","Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined With Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)","SKY","Inclusion Criteria:\n\n* Participants aged 18 to 75 years, regardless of gender;\n* ECOG Performance Status (PS) score of 0-1;\n* Expected survival duration of no less than 8 weeks;\n* Histologically or cytologically confirmed extensive small cell lung cancer (according to the VALG staging system);\n* Subjects must not have received systemic therapy or radical radiotherapy for extensive SCLC prior to enrollment.\n\nExclusion Criteria:\n\n* Tissue classifications of mixed small cell lung cancer and non-small cell lung cancer;\n* Patients who have undergone major surgical procedures within 28 days prior to the initial administration of the study drug, or those planning to undergo major surgery during the study period (as determined by the investigator);\n* Receipt of live attenuated vaccines within 28 days before the first dose or planned for the duration of the study;\n* Participation in another clinical trial within 28 days preceding initial dosing, involving any experimental agents;\n* History of receiving chest radiotherapy or plans for intensive chest radiotherapy prior to systemic therapy;\n* Any previous T-cell co-stimulation or immune checkpoint therapies administered;\n* Documented history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\\"",{"count":408,"type":22},202,[88],"Multicenter, Phase II Randomized Controlled Study of Adebrelimab Combined with Chemotherapy and Concurrent Low-Dose Radiotherapy (LDRT) for the Treatment of Extensive-Stage Small Cell Lung Cancer (SCLC)",[121],[254,413,414],"Adebrelimab","LDRT","2026-02-04",{"date":417,"type":35},"2026-02-09",{"date":419,"type":35},"2024-12-23",{"date":421,"type":22},"2028-12",{"name":41,"class":42},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":443,"completionDateStruct":445,"leadSponsor":447,"locationsCount":43},"100621717","phase-2-perioperative-ivonescimab-plus-s-1-and-oxaliplatin-sox-for-locally-advanced-gastric-or-gej-adenocarcinoma-100621717","NCT07374250","Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) for Locally Advanced Gastric or GEJ Adenocarcinoma","Perioperative Ivonescimab Plus S-1 and Oxaliplatin (SOX) Versus SOX Alone for Locally Advanced Gastric or GEJ Adenocarcinoma: A Multicenter Randomized Phase II Study","Huaxi","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Histologically confirmed gastric or gastroesophageal junction (G\u002FGEJ) adenocarcinoma.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n4. Clinically staged as T3-4a N+ M0 by computed tomography (CT) or magnetic resonance imaging (MRI).\n5. Considered eligible for curative resection.\n6. No prior antitumor therapy for the current disease.\n7. Adequate organ function, including hepatic, renal, and bone marrow function, as per prespecified laboratory criteria.\n8. Expected survival of ≥6 months.\n\nExclusion Criteria:\n\n1. Known mismatch repair-deficient (dMMR) or microsatellite instability-high (MSI-H) tumor.\n2. Uncontrolled hypertension, defined as systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg despite optimized antihypertensive therapy, or hypertension complicated by acute events (e.g., hypertensive crisis, hypertensive encephalopathy) that cannot be stably controlled.\n3. Tumor lesions with a bleeding tendency, including but not limited to: active ulcerative tumor lesions, hematemesis within 2 months prior to informed consent, high risk of major gastrointestinal bleeding as determined by the investigator.\n4. History of thromboembolic or arterial\u002Fvenous vascular events within 6 months prior to enrollment, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis, or pulmonary embolism.\n5. Gastrointestinal perforation or gastrointestinal obstruction within 6 months prior to enrollment.",{"count":432,"type":22},154,[88],"The purpose of this clinical trial is to evaluate whether perioperative ivonescimab in combination with S-1 and oxaliplatin (SOX) is effective in treating locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study will also assess the safety profile of this treatment regimen.\n\nPrimary Objective:\n\nTo determine whether perioperative ivonescimab plus SOX improves the pathological complete response (pCR) rate compared with SOX alone in patients with locally advanced gastric or GEJ adenocarcinoma.\n\nStudy Design:\n\nParticipants will be randomly assigned to receive either ivonescimab plus SOX or SOX alone to evaluate the potential added benefit of ivonescimab in this setting.\n\nParticipation Details:\n\nParticipants will receive the assigned treatment (ivonescimab plus SOX or SOX alone) every 21 days for approximately 4 months.\n\nThey will visit the clinic once every 3 weeks for evaluations, laboratory tests, and monitoring.\n\nParticipants will be asked to keep a daily diary to record any symptoms or side effects experienced during the study.",[205,436],"RCT",[438,439,206],"gastric cancer","Ivonescimab","2026-01-24",{"date":442,"type":35},"2026-01-28",{"date":444,"type":22},"2026-02-01",{"date":446,"type":22},"2027-12-31",{"name":41,"class":42},{"id":449,"slug":450,"hasResults":12,"nctId":451,"briefTitle":452,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":464,"leadSponsor":465,"locationsCount":4},"100620831","early-phase-1-exploratory-study-on-the-treatment-of-recurrent-and-refractory-hematological-malignancies-with-wgb-0302-injection-100620831","NCT07362732","Exploratory Study on the Treatment of Recurrent and Refractory Hematological Malignancies With WGb-0302 Injection","Inclusion Criteria:\n\n* 1\\. Age range: 18-75 years old, gender not limited;\n* 2\\. Expected survival time exceeds 12 weeks;\n* 3\\. According to the diagnostic criteria of the International Myeloma Working Group (IMWG) for multiple myeloma, the diagnosis is multiple myeloma (MM), and the expression of BCMA target antigen is confirmed by flow cytometry, bone marrow pathology, and immunohistochemistry.\n* 4\\. Having measurable multiple myeloma lesions:\n* 5\\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point;\n* 6\\. Before screening (at baseline), corresponding conditions should be met;\n* 7\\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;\n* 8\\. Those who can understand this experiment and have signed the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Accompanied by other uncontrolled malignant tumors;\n* 2\\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy less than 6 months after the first administration;\n* 3\\. Have received any anti myeloma treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, radiation therapy \\[excluding local radiotherapy for pain control\\], etc.) within 14 days prior to the first use of medication;\n* 4\\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;\n* 5\\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;\n* 6\\. Within 14 days prior to enrollment, there is an uncontrolled active infection. Note: If there is no evidence of active infection within 72 hours before enrollment, subjects who continue to use prophylactic antibiotics, antifungal drugs, or antiviral drugs are allowed;\n* 7\\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;\n* 8\\. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;\n* 9\\. Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial\u002Fvenous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;\n* 10\\. Long term use of immunosuppressants due to autoimmune diseases or organ transplantation, except for recent or current inhaled corticosteroid therapy;\n* 11\\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;\n* 12\\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.",{"count":455,"type":22},20,[25],"At present, the treatment of multiple myeloma (MM) has evolved from traditional chemotherapy to a comprehensive model that includes targeted drugs, immunotherapy, etc. However, the prognosis of recurrent\u002Frefractory MM patients remains severe. For patients who are already resistant to multiple major drugs such as proteasome inhibitors, immunomodulators, and CD38 monoclonal antibodies, the prognosis is particularly poor. B-cell maturation antigen (BCMA) plays a crucial role in regulating B cell proliferation and survival. BCMA is expressed in various hematological malignancies such as multiple myeloma and has become an important biomarker, promising therapeutic target, and research direction for these diseases.\n\nThe advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. The core of LNP mRNA technology targeting BCMA is to encapsulate the mRNA encoding specific proteins (such as anti BCMA related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection. The experimental drug WGb 0302 injection is a BCMA based messenger RNA (mRNA) therapeutic drug, formed by loading mRNA encoding BCMA receptor related proteins onto lipid nanoparticles (LNP).",[459],"Hematological Malignancies","2026-01-22",{"date":462,"type":35},"2026-01-23",{"date":444,"type":22},{"date":74,"type":22},{"name":41,"class":42},{"id":467,"slug":468,"hasResults":12,"nctId":469,"briefTitle":470,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":115,"enrollmentInfo":472,"targetDuration":4,"studyType":23,"phases":473,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":483,"locationsCount":4},"100618518","early-phase-1-exploratory-study-on-the-treatment-of-relapsed-and-refractory-b-cell-malignant-tumors-with-wgb-0301-injection-100618518","NCT07332663","Exploratory Study on the Treatment of Relapsed and Refractory B-cell Malignant Tumors With WGb-0301 Injection","Inclusion Criteria:\n\n* 1\\. Age range of 18-70 years old, gender not limited;\n* 2\\. Expected survival time exceeds 12 weeks;\n* 3\\. B-cell lymphoma or lymphocytic leukemia diagnosed with CD19+, with no standard treatment options recommended according to guidelines and meeting the corresponding frontline treatment line requirements;\n* 4\\. There are assessable lesions (applicable only to lymphoma patients);\n* 5\\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point;\n* 6\\. The main organ functions well and the relevant examination indicators meet the corresponding requirements;\n* 7\\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;\n* 8\\. Those who can understand this experiment and have signed the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Accompanied by other uncontrolled malignant tumors;\n* 2\\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy;\n* 3\\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;\n* 4\\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;\n* 5\\. Participants with atrial or ventricular involvement;\n* 6\\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;\n* 7\\. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;\n* 8\\. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial\u002Fvenous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;\n* 9\\. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy;\n* 10\\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;\n* 11\\. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections);\n* 12\\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.",{"count":223,"type":22},[25],"Malignant hematological tumors mainly derived from adult B cells are mainly acute lymphoblastic leukemia (ALL) and non Hodgkin lymphoma (NHL). Overall, although existing therapies have significantly improved the survival rates of most patients, the treatment of relapsed\u002Frefractory patients still faces significant challenges. CD19 is one of the most clinically valuable targets for B-cell malignant hematological tumors.\n\nThe advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. The core of LNP mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.\n\nThe experimental drug WGb-0301 injection is a CD19 based messenger RNA (mRNA) therapeutic mRNA drug, formed by loading mRNA onto lipid nanoparticles (LNP). WGb-0301 injection has demonstrated efficient B-cell clearance activity and good safety in non clinical settings, supporting further clinical exploration in B-cell malignancies. It is expected to provide an innovative, safe, and accessible immunotherapy for B-cell malignancies, bringing better clinical benefits to more patients with B-cell malignancies.",[476],"B Cell Malignancies","2025-12-31",{"date":479,"type":35},"2026-01-12",{"date":481,"type":22},"2026-01-01",{"date":74,"type":22},{"name":41,"class":42},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":4,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":491,"targetDuration":4,"studyType":23,"phases":492,"briefSummary":493,"conditions":494,"keywords":496,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":43},"100583513","phase-2-low-dose-radiation--sbrt--tislelizumab-plus-platinum-based-chemotherapy-in-stage-a-b-non-small-cell-lung-cancer-100583513","NCT06877299","Low-Dose Radiation + SBRT + Tislelizumab Plus Platinum-based Chemotherapy in Stage ⅡA-ⅢB Non-small Cell Lung Cancer","Low-Dose Radiation + Stereotactic Body Radiotherapy Followed by Tislelizumab Plus Platinum-based Chemotherapy As Neoadjuvant Therapy in Patients With Resectable StageⅡA-ⅢB Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 and ≤ 75 years;\n2. Patients with untreated stage IIA-IIIB non-small cell lung cancer, diagnosed cytologically or histologically (according to the AJCC 9th edition of thoracic tumor staging);\n3. Pulmonary lesions will be assessed as resectable or potentially resectable by a multidisciplinary team, including a thoracic surgeon;\n4. At least one imaging-measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1);\n5. Ability to provide tumor tissue or cell wax blocks that meet quality control standards for PD-L1 expression testing.\n\nExclusion Criteria:\n\n1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；\n2. Patients with known EGFR-sensitive mutations or ALK fusion.\n3. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;\n4. Subjects with any known or suspected autoimmune disorder or immunodeficiency, with the following exceptions: hypothyroidism, hormone therapy is not needed, or well controlled at physiological dose; controlled type I diabetes;\n5. Active infection requiring systemic treatment.",{"count":117,"type":22},[88],"This phase II study aims to evaluate the efficacy and safety of low-dose radiation + SBRT + Tislelizumab plus platinum-based chemotherapy as neoadjuvant therapy for stage II-III non-small cell lung cancer.",[317,495],"Non-small Cell Lung Cancer",[497,274,498,255,145],"Neoadjuvant","Stereotactic Body Radiotherapy","2025-12-29",{"date":501,"type":35},"2026-01-02",{"date":503,"type":35},"2025-07-04",{"date":505,"type":22},"2028-01-01",{"name":41,"class":42},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":514,"targetDuration":4,"studyType":23,"phases":516,"briefSummary":517,"conditions":518,"keywords":520,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":530},"100525420","phase-2-phase-ii-trial-low-dose-radiation--sbrt--sintilimab--chemotherapy-vs-sintilimab--chemotherapy-in-locally-advanced-or-metastatic-squamous-cell-lung-cancer-100525420","NCT06121505","Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer","Low-dose Radiation Therapy and Stereotactic Body Radiation Therapy Combined With PD-1 Inhibitor Sintilimab and Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Patients With Locally Advanced or Metastatic Squamous Cell Lung Cancer: A Randomized, Phase II Multicenter Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 75 years old;\n2. Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);\n3. According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;\n4. Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;\n5. Have not received any systemic anti-tumor treatment for locally advanced or metastatic disease in the past;\n\nExclusion Criteria:\n\n1. The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；\n2. The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;\n3. EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;\n4. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;\n5. Pregnant or lactating women;",{"count":515,"type":22},114,[88],"This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer.\n\nThere will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.",[519],"Lung Squamous Cell Carcinoma",[521,255,414,519],"SBRT","2025-12-09",{"date":524,"type":35},"2025-12-17",{"date":526,"type":35},"2024-03-01",{"date":528,"type":22},"2027-02-28",{"name":41,"class":42},6,{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":538,"targetDuration":4,"studyType":23,"phases":539,"briefSummary":540,"conditions":541,"keywords":543,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":43},"100597685","phase-1-oncolytic-virus-in-esophageal-squamous-cell-carcinoma-100597685","NCT07061704","Oncolytic Virus in Esophageal Squamous Cell Carcinoma","Oncolytic Virus Combined With Chemotherapy and Immune Checkpoint Inhibitors in Patients With Initially Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma：An Open-label, Single-arm Phase II Study","Inclusion Criteria:\n\n* A. Age 18-80 years B. Diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) with\u002Fwithout cervical lymph node metastases.\n\nC. Ability to provide fresh tumor tissue samples (baseline) D. Normal major organ function E. Performance status (PS) score ≤ 1 F. Patients of childbearing potential must use contraception G. Voluntary participation with signed informed consent H. Able to comply with the study protocol, follow-up schedule, and other protocol requirements.\n\nExclusion Criteria:\n\n* A. Received prior antitumor chemotherapy, radiotherapy, or immunotherapy before the first-line treatment.\n\nB. High risk of gastrointestinal bleeding, esophageal fistula, or esophageal perforation C. Poor nutritional status D. Immune-related adverse events during prior radical treatment, such as Grade ≥3 pneumonitis, myocarditis, etc.\n\nE. Signs and symptoms of interstitial diseases F. Presence of any severe and\u002For uncontrolled medical conditions G. Presence of concurrent malignancies H. Presence of other autoimmune diseases, or prolonged use of immunosuppressants or steroids I. Difficulty in patient communication or inability to comply with long-term follow-up J. Other conditions deemed unsuitable by the investigator",{"count":54,"type":22},[56,88],"This clinical trial is designed to evaluate the preliminary efficacy and safety of an oncolytic virus combined with chemotherapy and an immune checkpoint inhibitor in patients with initially unresectable, locally advanced esophageal squamous cell carcinoma (ESCC). The primary endpoints are safety, surgical conversion rate and event-free survival (EFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), and quality of life (QoL). Exploratory endpoints include biomarker analyses such as single-cell sequencing.",[542],"Esophageal Cancer",[544,545,546,547,362],"esophageal cancer","Oncolytic Virus","clinical efficacy","safety","2025-12-01",{"date":550,"type":35},"2025-12-08",{"date":552,"type":35},"2025-08-01",{"date":554,"type":22},"2027-09-01",{"name":41,"class":42},{"id":557,"slug":558,"hasResults":12,"nctId":559,"briefTitle":560,"officialTitle":561,"acronym":4,"eligibilityCriteria":562,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":567,"conditions":568,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":576,"locationsCount":4},"100609165","phase-3-patient-reported-symptom-care-versus-usual-care-after-esophageal-cancer-surgery-a-single-center-phase-3-randomized-trial-100609165","NCT07211009","Patient-Reported Symptom Care Versus Usual Care After Esophageal Cancer Surgery: A Single-Center Phase 3 Randomized Trial","A Single-Center, Randomized, Controlled, Phase III Clinical Study of Patient-Reported Outcome-Based Symptom Management Versus Conventional Management in Postoperative Esophageal Cancer Patients","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. Pathologically confirmed esophageal cancer.\n3. Planned to undergo curative (radical) surgical resection.\n4. R0 resection.\n5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1.\n6. Adequate function of major organs.\n7. Willing to complete questionnaire surveys.\n8. Voluntarily agrees to participate and signs the informed consent form.\n9. Good compliance and able to complete follow-up as scheduled.\n\nExclusion Criteria:\n\n1. Human immunodeficiency virus (HIV) infection.\n2. Psychiatric disorder.\n3. Any other malignancy within the past 5 years (except completely cured carcinoma in situ of the cervix or basal cell\u002Fsquamous cell carcinoma of the skin).\n4. Patient ultimately did not undergo curative (radical) surgical resection.\n5. Any unstable systemic disease (including active, uncontrolled gastrointestinal ulcer; active infection; grade 4 hypertension; unstable angina; congestive heart failure; unstable cerebrovascular disease; thrombotic disease; hepatic, renal, or metabolic disease; or unhealed fracture\u002Fwound as determined by the surgeon).\n6. Difficulty in communication or inability to comply with long-term follow-up.\n7. Any other condition deemed unsuitable by the investigator.",{"count":564,"type":22},240,[566],"PHASE3","Symptom management is fundamental to clinical care, and symptom monitoring is an effective means to detect potential adverse events early and prevent serious complications. Extensive studies show that symptom management based on patient-reported outcomes (PROs) can reduce symptom burden, improve functional status and quality of life, lower emergency visits and readmissions, and even prolong survival. However, in the field of esophageal cancer surgery, prospective clinical studies assessing the feasibility of postoperative PRO-based symptom management remain lacking. This project proposes a randomized controlled trial (RCT) in China to systematically evaluate the effectiveness and feasibility of PRO-based symptom management after esophageal cancer surgery. Through this clinical study, we aim to assess both the impact and the implementability of introducing a proactive, patient-centered PRO symptom-management model into esophageal surgical care.",[569],"Esophageal Cancer (EsC)","2025-09-29",{"date":572,"type":35},"2025-10-07",{"date":574,"type":22},"2025-10-15",{"date":74,"type":22},{"name":41,"class":42},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":84,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":43},"100604791","phase-1-endostatin-adenovirus-with-checkpoint-inhibitor-in-advanced-head-and-neck-or-esophageal-cancer-100604791","NCT07154108","Endostatin Adenovirus With Checkpoint Inhibitor in Advanced Head and Neck or Esophageal Cancer","A Phase I, Open-label, Two-cohort Study of Recombinant Human Endostatin Adenovirus in Combination With Immune Checkpoint Inhibitors in Patients With Recurrent or Metastatic Head and Neck Cancer or Esophageal Squamous Cell Carcinoma","* Cohort A (Head and Neck Cancer)\n* Cohort B (Esophageal Squamous Cell Carcinoma)\n\nInclusion Criteria:\n\n1. Age ≥18 years\n\n   * Cohort A (Head and Neck Cancer): ≤70 years\n   * Cohort B (Esophageal Squamous Cell Carcinoma): ≤75 years\n2. Histologically or cytologically confirmed recurrent or metastatic:\n\n   * Cohort A: Head and Neck Cancer\n   * Cohort B: ESCC, AJCC 9th edition stage IV\n3. Prior treatment:\n\n   * Cohort A: ≥1 prior platinum-based chemotherapy regimen or platinum-refractory\u002Fintolerant\n   * Cohort B: Prior immune checkpoint inhibitor (ICI) therapy with documented acquired resistance after prior PR or SD\n4. At least one lesion accessible for intratumoral injection\n\n   * Cohort A: measurable lesion ≥2 cm by RECIST 1.1\n   * Cohort B: superficial metastatic lymph nodes (cervical or supraclavicular)\n5. ECOG performance status\n\n   * Cohort A: 0-2\n   * Cohort B: 0-1\n6. Adequate organ function\n7. Life expectancy ≥12 weeks (Cohort A)\n8. No anti-tumor therapy (chemotherapy, radiotherapy, biotherapy, antiviral) within 4 weeks prior to enrollment (Cohort A)\n9. Availability of fresh tumor tissue specimen or pathological slides from the injection target lesion (Cohort B)\n10. Male\u002Ffemale patients of childbearing potential must use effective contraception during study and for at least 6 months after treatment\n11. Voluntary participation with signed informed consent\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to study drugs\n2. Lesions unsuitable for injection due to proximity to major blood vessels, nerves, or hollow organs, or with extensive necrosis\n3. Deeply located lesions with high procedural difficulty (Cohort B)\n4. Concurrent radiotherapy to target lesion(s) (Cohort A)\n5. Prior anti-angiogenic therapy (Cohort A)\n6. Immunosuppressive therapy or systemic corticosteroids \\>10 mg\u002Fday prednisone (or equivalent) within 2 weeks prior to enrollment\n7. Active autoimmune disease or history of autoimmune disease\n8. Congenital or acquired immunodeficiency\n9. Severe coagulopathy, bleeding tendency, or high-risk lesions (Cohort B)\n10. Poor nutritional status (Cohort B)\n11. Interstitial lung disease with symptoms or radiographic evidence (Cohort B)\n12. Severe uncontrolled systemic disease or recent myocardial infarction (\\\u003C3 months)\n13. Acute infection\n14. Pregnancy or breastfeeding\n15. Other malignancy besides ESCC (Cohort B)\n16. Patients unlikely to comply with follow-up or participation requirements\n17. Any condition deemed unsuitable for enrollment by the investigator",{"count":54,"type":22},[56],"This is a Phase I, open-label, dual-cohort clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of intratumoral injection of recombinant human endostatin adenovirus in combination with a PD-1 inhibitor in patients with recurrent or metastatic head and neck cancer, or in patients with esophageal squamous cell carcinoma (ESCC) with superficial lymph node metastasis.",[542,588],"Head and Neck Cancer (H&Amp;Amp;Amp;N)",[590,591,592,593,547,594],"Esophageal cancer","Esophageal squamous cell carcinoma","Head and neck cancer","Endostatin Adenovirus","Clinical efficacy","2025-08-27",{"date":597,"type":35},"2025-09-04",{"date":599,"type":22},"2025-09-01",{"date":601,"type":22},"2027-08-01",{"name":41,"class":42},""]