[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jiangsu Cancer Institute & Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":379},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,42,64,90,115,138,164,187,213,236,259,282,309,333,355],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100639050","phase-2-a-single-arm-multicenter-clinical-study-of-fruquintinib-combined-with-serplulimab-and-chemotherapy-as-first-line-treatment-for-patients-with-rasbraf-mutated-advanced-colorectal-cance-100639050",false,"NCT07622550","A Single-arm, Multicenter Clinical Study of Fruquintinib Combined With Serplulimab and Chemotherapy as First-line Treatment for Patients With RAS\u002FBRAF-mutated Advanced Colorectal Cance","Inclusion Criteria:\n\n* 18 to 75 years (inclusive), male or female.\n* Diagnosis of advanced unresectable or metastatic colorectal cancer.\n* Confirmed RAS\u002FBRAF mutation by testing.\n* No prior systemic therapy for unresectable or metastatic colorectal cancer. (Prior adjuvant or neoadjuvant chemotherapy with one regimen is allowed if recurrence occurred ≥6 months after completion of chemotherapy.)\n* ECOG 0 - 1.\n* Adequate major organ and bone marrow function (without any blood component or cell growth factor support within 14 days before enrollment):\n\n  1. Hematology: absolute neutrophil count ≥1.5 × 10⁹\u002FL, platelet count ≥100 × 10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  2. International normalized ratio (INR) ≤1.5 × upper limit of normal (ULN), and activated partial thromboplastin time (APTT) ≤1.5 × ULN.\n  3. Liver function: total bilirubin ≤1.5 × ULN; ALT\u002FAST ≤2.5 × ULN (≤5 × ULN in patients with liver metastases).\n  4. Renal function: serum creatinine ≤1.5 × ULN, and creatinine clearance (CCr) ≥50 mL\u002Fmin.\n* Female patients of childbearing potential must have a negative serum pregnancy test within 14 days before treatment. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence) with their partners during the study and for at least 6 months after the last dose\n\nExclusion Criteria:\n\n* \\- History of hypersensitivity to any anti-angiogenic targeted agent, any component of monoclonal antibodies, capecitabine, oxaliplatin, or other platinum-based drugs.\n* Untreated central nervous system (CNS) metastases.\n* Major surgery or severe trauma within 4 weeks prior to first study drug administration.\n* Current use of immunosuppressive agents, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent), and continued use within 2 weeks before enrollment.\n* Presence of any active autoimmune disease or history of autoimmune disease.\n* History of other malignancies within the past 5 years, except for radically resected basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.\n* Known inherited or acquired bleeding\u002Fthrombotic tendency (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or currently receiving thrombolytic or anticoagulant therapy.\n* Currently active bleeding or significant bleeding tendency within 3 months (i.e., patients at high risk of bleeding).","ALL","18 Years","75 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of Fruquintinib combined With Serplulimab and chemotherapy as first-line treatment for RAS\u002FBRAF-mutated unresectable advanced colorectal cancer. The study plans to enroll 80 patients with RAS\u002FBRAF-mutated unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with Fruquintinib combined With Serplulimab and chemotherapy . The primary endpoint of the study is PFS, and secondary endpoints include ORR, DCR, OS, and safety.",[26],"Metastatic Colorectal Cancer (CRC)",[28],"RAS\u002FBRAF-mutated","NOT_YET_RECRUITING","2026-05-28",{"date":32,"type":33},"2026-06-03","ACTUAL",{"date":35,"type":20},"2026-06-15",{"date":37,"type":20},"2028-08-15",{"name":39,"class":40},"Jiangsu Cancer Institute & Hospital","OTHER",16,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100640119","phase-2-queen-apple-a-single-arm-multicenter-prospective-phase-ii-clinical-study-of-iparomlimab-and-tuvonralimab-ql1706-in-combination-with-anlotinib-hydrochloride-and-nab-paclitaxel-as-first-line-treatment-for-advanced-triple-negative-breast-cancer-100640119","NCT07601178","QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.\n2. Female patients aged between 18 and 75 years.\n3. Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC \\\u003C1%), PR negative (IHC \\\u003C1%), HER2 negative (IHC -\u002F+ or IHC ++ but FISH\u002FCISH negative). Priority is given to pathology from metastatic lesions; if metastatic lesion pathology is not available, primary lesion pathology may be used.\n4. TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent\u002Fmetastatic disease who are not suitable for surgery, and have not received prior systemic therapy for advanced disease. Prior neoadjuvant and\u002For adjuvant therapy with taxanes or other anti-tumor treatments is permitted, provided that there was no disease progression during neoadjuvant therapy, and the interval between completion of taxane-based (neo)adjuvant therapy and recurrence\u002Fmetastasis is ≥6 months.\n5. Suitable for nab-paclitaxel treatment.\n6. At least one measurable tumor lesion according to RECIST 1.1 criteria.\n7. Expected survival ≥3 months.\n8. ECOG performance status 0 or 1.\n9. Adequate organ function, including:\n\n1)Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥100×10⁹\u002FL; hemoglobin (HB) ≥90 g\u002FL.\n\n2)Liver function: Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN; if liver metastases are present, ALT and AST must be ≤5×ULN.\n\n3)Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n\n10.Participants of childbearing potential must use appropriate contraception during the study and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must not be lactating.\n\nExclusion Criteria:\n\n1. Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.\n2. Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.\n3. Symptomatic brain\u002Fleptomeningeal metastases and\u002For spinal cord metastases.\n4. Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes mellitus requiring only stable-dose insulin replacement therapy.\n5. Major surgery within 3 weeks before study initiation, or failure to recover from surgery.\n6. History of organ transplantation or autologous\u002Fallogeneic stem cell transplantation.\n7. Known or self-reported human immunodeficiency virus (HIV) infection.\n8. HBV-DNA positive or HCV-DNA positive (copy number \\>10³).\n9. Prior treatment with any agent targeting the mechanism of tumor immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or immune cell therapy.\n10. Prior treatment with anti-angiogenic targeted therapy.\n11. Hypertension that cannot be well controlled with a single antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).\n12. Arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months before enrollment.\n13. Presence of other malignancies within 5 years before enrollment, except for TNBC.\n14. Tumor invasion or compression of surrounding major blood vessels or organs.\n15. Active central nervous system (CNS) metastatic lesions.\n16. Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n17. History of myocarditis, cardiomyopathy, or malignant arrhythmias.\n18. History of significant bleeding tendency or coagulation dysfunction.\n19. History of esophageal-gastric varices, severe ulcer, non-healing wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.\n20. Known active tuberculosis (TB).\n21. History of or current non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic corticosteroid therapy.\n22. Major surgery or severe trauma within 30 days before the first dose, or planned major surgery within 30 days after the first dose; minor local surgery within 3 days before the first dose.\n23. Platelet or red blood cell transfusion within 4 weeks before initiation of study drug treatment.\n24. Receipt of live vaccine within 4 weeks before the first dose, or planned receipt of live vaccine during the study.\n25. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.\n26. Patients judged by the investigator to be unsuitable for participation in this study.",{"count":49,"type":20},34,[23],"This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer.\n\nA total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study:\n\nEnrolled participants receive QL1706 (5 mg\u002Fkg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg\u002Fm², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.\n\nThe study consists of a screening period (from the signing of informed consent to no more than 28 days before the first dose), a treatment period (including on-treatment visits and end-of-treatment visit), and a follow-up period (including safety follow-up and survival follow-up).\n\nScreening Period:\n\nThe screening period begins after the participant signs the informed consent form and ends at enrollment, lasting no more than 28 days. Eligible participants are those with pathologically confirmed, previously untreated first-line triple-negative breast cancer. During screening, participant information, samples, and blood specimens are collected as needed. Participants who meet all inclusion criteria and none of the exclusion criteria are enrolled.\n\nTreatment Period:\n\nStudy drugs are administered within 3 days of enrollment. Each treatment cycle is 3 weeks. Study treatment continues until disease progression, intolerable toxicity, initiation of new anti-cancer therapy, loss to follow-up, death, withdrawal of informed consent, or other reasons, with a maximum treatment duration of 2 years (whichever occurs first). Safety assessments are performed every 3 weeks, and tumor imaging evaluations are performed every 6 weeks (±7 days) according to RECIST v1.1 criteria.\n\nFollow-up Period:\n\nWhen participants discontinue study treatment or withdraw early, they are still required to complete the corresponding assessments as specified in the protocol.\n\nSafety Follow-up: At 30 days (±7 days) after the last dose, participants return to the site for one follow-up visit, during which blood samples are collected and safety examinations are performed.\n\nSurvival Follow-up: Every 2 months. Survival status and subsequent treatment information are collected by telephone or other appropriate means.",[53],"TNBC, Triple Negative Breast Cancer","RECRUITING","2026-05-20",{"date":57,"type":33},"2026-05-22",{"date":59,"type":33},"2026-04-17",{"date":61,"type":20},"2027-09-15",{"name":39,"class":40},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":73,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":63},"100627265","phase-2-a-clinical-study-of-iparomlimab-and-tuvonralimab-combined-with-bevacizumab-and-alternating-triweekly-capoxmcapiri-regimen-as-first-line-treatment-for-unresectable-advanced-colorectal-cancer-100627265","NCT07446387","A Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX\u002FmCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer","A Prospective, Single-arm, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab Combined With Bevacizumab and Alternating Triweekly CAPOX\u002FmCAPIRI Regimen as First-line Treatment for Unresectable Advanced Colorectal Cancer","Inclusion Criteria:\n\n* 1\\. Age 18-75 years;\n* 2\\. Patients with histologically or cytologically confirmed unresectable, advanced colorectal cancer;\n* 3\\. No prior systemic treatment;\n* 4\\. ECOG PS score ≤2;\n* 5\\. Expected survival ≥3 months;\n* 6\\. MSS\u002FMSI-L status;\n* 7\\. At least one evaluable lesion based on RECIST 1.1 criteria;\n* 8\\. No prior systemic chemotherapy or other systemic therapy, or only received adjuvant chemotherapy with disease progression or recurrence within 6 months after completion of treatment;\n* 9\\. Adequate organ function reserve, with specific hepatic, renal, and hematologic parameters as follows:\n\n  1. White blood cell count ≥3.5×10⁹\u002FL\n  2. Absolute neutrophil count ≥1.5×10⁹\u002FL\n  3. Hemoglobin ≥100 g\u002FL\n  4. Platelets ≥80×10⁹\u002FL\n  5. Serum liver enzymes ≤2.5× upper limit of normal (ULN) in patients without liver metastases\n  6. Serum liver enzymes ≤5× ULN in patients with liver metastases\n  7. Serum bilirubin ≤1.5× ULN\n  8. Serum creatinine ≤1.5× ULN\n* 10\\. No history of other malignancies;\n* 11\\. Voluntary participation in this study with signed informed consent.\n\nExclusion Criteria:\n\n* 1\\. Prior hypersensitivity to any of the study drugs;\n* 2\\. Active or known or suspected autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n* 3\\. Presence of non-measurable lesions (e.g., pleural effusion\u002Fascites, carcinomatous lymphangitis, diffuse liver involvement, bone metastases);\n* 4\\. Pregnant or lactating women;\n* 5\\. Uncontrolled symptomatic brain metastases or psychiatric disorders preventing accurate expression of subjective symptoms;\n* 6\\. Vital organ function failure;\n* 7\\. Conditions affecting drug absorption\u002Fdistribution\u002Fmetabolism\u002Fexcretion (e.g., seizures, central nervous system diseases, cognitive impairment due to psychiatric disorders, chronic diarrhea, cachexia, etc.);\n* 8\\. Patients with complete or incomplete intestinal obstruction;\n* 9\\. History of severe cardiac disease (including congestive heart failure, uncontrolled high-risk arrhythmia, angina requiring medication, definite valvular heart disease history, severe myocardial infarction, refractory hypertension);\n* 10\\. Active infection requiring systemic treatment;\n* 11\\. Known history of HIV infection;\n* 12\\. Known history of hepatitis B or active hepatitis C virus infection;\n* 13\\. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":72,"type":20},70,[23],"This study is a prospective, single-arm, multicenter exploratory clinical study aimed at evaluating the efficacy and safety of iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX\u002FmCAPIRI regimen as first-line treatment for unresectable advanced colorectal cancer. The study plans to enroll 70 patients with unresectable advanced metastatic colorectal cancer. After evaluation and confirmation of meeting enrollment criteria, patients will receive treatment with iparomlimab and tuvonralimab combined with bevacizumab and alternating triweekly CAPOX\u002FmCAPIRI regimen. The primary endpoint of the study is ORR, and secondary endpoints include PFS, DoR, OS, and safety.",[26],[77,78,79,80,81],"mCRC","bevacizumab","QL1706","Combination therapy","Alternating chemotherapy","2026-05-07",{"date":84,"type":33},"2026-05-12",{"date":86,"type":20},"2026-05-30",{"date":88,"type":20},"2029-12-31",{"name":39,"class":40},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":96,"maxAge":4,"enrollmentInfo":97,"targetDuration":4,"studyType":21,"phases":99,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":63},"100626424","phase-2-exploratory-clinical-trial-of-oral-paclitaxel-plus-radiotherapy-in-patients-with-locally-advanced-unresectable-esophageal-squamous-cell-carcinoma-100626424","NCT07435454","Exploratory Clinical Trial of Oral Paclitaxel Plus Radiotherapy in Patients With Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Histologically confirmed locally advanced unresectable esophageal squamous cell carcinoma (cTXN+M0 or cT2-T4aNXM0).\n2. Considered eligible for definitive chemoradiotherapy.\n3. Age ≥ 70 years and\u002For intolerant to intravenous chemotherapy due to comorbidities, with severe dysphagia\u002Ffeeding obstruction.\n4. Disease evaluable by qualitative radiologic assessment per the local investigator.\n5. Not eligible for curative surgery.\n6. Adequate hematologic function, defined as: ANC ≥ 1500\u002FμL, platelet count ≥ 100,000\u002FμL, and hemoglobin ≥ 9.0 g\u002FdL or ≥ 5.6 mmol\u002FL.\n7. Adequate renal function, defined as: creatinine ≤ 1.5 × ULN; or for patients with creatinine \\> 1.5 × ULN, measured or calculated creatinine clearance ≥ 60 mL\u002Fmin.\n8. Adequate hepatic function, defined as: total bilirubin ≤ 1.5 × ULN; or for patients with total bilirubin \\> 1.5 × ULN, direct bilirubin ≤ ULN provided ALT\u002FAST ≤ 2.5 × ULN and albumin ≥ 3.0 g\u002FdL.\n9. Adequate coagulation function, defined as: INR ≤ 1.5 × ULN, unless the patient is on anticoagulant therapy with PT or aPTT within the therapeutic range.\n10. Negative urine or serum pregnancy test within 24 hours prior to the first dose of study intervention.\n11. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.\n\nExclusion Criteria:\n\n1. Direct tumor invasion into adjacent organs, such as the aorta or trachea (i.e., T4b disease).\n2. Prior chemotherapy or radiotherapy for esophageal cancer.\n3. Any prior systemic anticancer therapy for esophageal cancer.\n4. Major surgery other than feeding tube insertion, open biopsy, or significant trauma within 28 days before randomization, or anticipated major surgery during study treatment.\n5. History of other malignancy within the past 5 years, except carcinoma in situ of the cervix or basal cell carcinoma.\n6. Gastric fistula or esophageal fistula.\n7. Active infection requiring systemic therapy.\n8. Known history of HIV, HBV, or HCV infection.\n9. Participation in a study of an investigational drug or device within 4 weeks prior to the first study treatment.\n10. History of non-infectious pneumonitis requiring corticosteroid therapy, or current pneumonitis.\n11. Known hypersensitivity to any study drug.\n12. Inability or unwillingness to comply with protocol requirements as assessed by the investigator.","70 Years",{"count":98,"type":20},22,[23],"This study aims to investigate the safety and efficacy of oral paclitaxel combined with radiotherapy in the treatment of locally advanced unresectable esophageal squamous cell carcinoma.",[102],"Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma",[104,105,106],"esophageal carcinoma","oral paclitaxel","radiotherapy","2026-02-25",{"date":109,"type":33},"2026-02-27",{"date":111,"type":33},"2025-12-01",{"date":113,"type":20},"2027-12-01",{"name":39,"class":40},{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":15,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":127,"conditions":128,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":4},"100624359","phase-2-perioperative-chemotherapy-with-low-dose-radiotherapy-and-tislelizumab-for-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100624359","NCT07408609","Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Phase II Multicenter Randomized Controlled Trial of Perioperative Chemotherapy Combined With Low-Dose Radiotherapy and Tislelizumab Versus Chemotherapy Alone in Patients With Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1.Voluntary participation with written informed consent obtained; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert type II\u002FIII) by endoscopic biopsy (pathology from outside institutions must be reviewed by the study center); 3. Staged as cT1-2N1-3M0 or cT3-4aN0-3M0 according to the AJCC 8th edition, based on endoscopy and imaging (CT, MRI, or PET-CT); 4. Age ≥20 and ≤80 years, male or female; ECOG performance status of 0-1; 5. Presence of measurable and\u002For non-measurable disease per RECIST v1.1; 6.No prior systemic antitumor therapy, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational agents; Adequate organ function (no blood products or growth factors within 2 weeks prior to screening); 7. Women of childbearing potential must have a negative pregnancy test within 72 hours prior to first dosing and agree to use effective contraception during the study and for 5 months after the last dose; men with partners of childbearing potential must use effective contraception during the study and for 7 months after the last dose.\n\nExclusion Criteria:\n\n1. History of surgery for gastric or gastroesophageal junction tumors;\n2. Prior history of fistula formation caused by invasion of the primary tumor; 3.High risk of gastrointestinal bleeding or perforation;\n\n4.Poor nutritional status, defined as BMI \\\u003C18.5 kg\u002Fm² or PG-SGA score ≥9; 5. Major surgery or severe trauma within 4 weeks prior to first study drug administration; Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 6. Prior or ongoing treatment with anti-PD-1\u002FPD-L1 antibodies, chemotherapy, radiotherapy, or targeted therapy; 7. Use of any investigational drug within 4 weeks prior to first study drug administration; Requirement for systemic corticosteroids; 8. Prior receipt of antitumor vaccines or live vaccines within 4 weeks before first study drug administration; 9. Active autoimmune disease or history of autoimmune disease; 10.History of immunodeficiency, including HIV infection, other acquired or congenital immunodeficiency, solid organ transplantation, or allogeneic bone marrow transplantation; 11.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 12.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 13.Severe infection (CTCAE grade \\>2) within 4 weeks prior to treatment, including infections requiring hospitalization; evidence of active pulmonary infection at baseline imaging or infections requiring antibiotics within 2 weeks prior to enrollment (prophylactic antibiotics excluded); 14.History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 15.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 16.Active hepatitis B (HBV DNA ≥2,000 IU\u002FmL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 17.Any condition requiring systemic corticosteroid or immunosuppressive therapy within 14 days prior to treatment, except for minimal systemic absorption routes or short-term (≤7 days) prophylactic use; 18.Uncontrolled clinically significant cardiac disease, including NYHA class II or higher heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant arrhythmias requiring intervention; 19.Severe infection (CTCAE grade \\>2) within 4 weeks prior to treatment; History of interstitial lung disease, noninfectious pneumonitis, pulmonary fibrosis, or other uncontrolled acute pulmonary disease; 20.Active tuberculosis, history of active tuberculosis within 1 year prior to enrollment, or inadequately treated tuberculosis more than 1 year prior; 21.Active hepatitis B (HBV DNA ≥2,000 IU\u002FmL) or hepatitis C infection (HCV antibody positive with detectable HCV RNA); 22.Grade \\>1 abnormalities in serum sodium, potassium, or calcium within 2 weeks prior to enrollment that cannot be corrected with treatment.","20 Years","80 Years",{"count":125,"type":20},114,[23],"This study is a prospective, multicenter, randomized, phase II clinical trial enrolling patients with resectable locally advanced gastric or gastroesophageal junction adenocarcinoma. The study aims to compare the efficacy and safety of perioperative chemotherapy combined with low-dose radiotherapy and tislelizumab versus perioperative chemotherapy alone in this patient population.",[129],"Gastric or Gastroesophageal Junction Adenocarcinoma","2026-02-12",{"date":132,"type":33},"2026-02-13",{"date":134,"type":20},"2026-02-26",{"date":136,"type":20},"2031-02-20",{"name":39,"class":40},{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":145,"minAge":16,"maxAge":17,"enrollmentInfo":146,"targetDuration":4,"studyType":21,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":63},"100624270","phase-2-iparomlimab-and-tuvonralimab-ql1706-combined-with-standard-chemotherapy-or-combined-with-intraperitoneal-perfusion-chemotherapy-and-olaparib-as-neoadjuvant-therapy-for-advanced-ovarian-cancer-100624270","NCT07407452","Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer","A Prospective, Open-label, Multicenter Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Chemotherapy and Olaparib as Neoadjuvant Therapy for Advanced Ovarian Cancer","Inclusion Criteria:\n\n* Participants voluntarily join this study, sign the informed consent form, and strictly comply with the protocol requirements;\n* Female patients aged between 18 and 75 years;\n* Patients who have undergone open surgery, laparoscopic surgery, or core needle aspiration biopsy, and have been histopathologically confirmed as having epithelial ovarian cancer (high-grade serous adenocarcinoma, endometrioid adenocarcinoma), peritoneal cancer, or fallopian tube cancer, FIGO 2018 Stage III-IV;\n* Meet the indications for neoadjuvant chemotherapy in ovarian cancer: ① Preoperative assessment by gynecologic oncologists (with multidisciplinary consultation when necessary) indicates low likelihood of achieving R0 resection with primary debulking surgery; ② Physical condition unable to tolerate PDS, unsuitable for immediate surgery (e.g., high perioperative risk, advanced age, medical comorbidities, etc.); ③ No prior systemic anti-tumor treatment for ovarian cancer (including but not limited to radiotherapy, chemotherapy, surgery, targeted therapy, and immunotherapy); Note: Lymph node dissection or biopsy performed for clinical staging purposes after obtaining histopathology via needle biopsy, laparoscopic exploration, or other methods is permitted;\n* Accept BRCA1\u002F2 genetic mutation or HRD testing;\n* Presence of at least one measurable lesion according to RECIST 1.1 criteria;\n* Expected survival time ≥12 weeks;\n* ECOG score 0-1 (for Cohort 1), ECOG score 2 (for Cohort 2);\n* Adequate organ function, including:\n\nBone marrow function: Absolute neutrophil count ≥1,500\u002FμL; Platelets ≥100,000\u002FμL; Hemoglobin ≥10 g\u002FdL Hepatic function: Total bilirubin ≤1.5× upper limit of normal (ULN) or direct bilirubin ≤1.0× ULN; AST and ALT ≤2.5× ULN; Must be ≤5× ULN when liver metastases are present Renal function: Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n\n* Participants of childbearing potential must use appropriate contraceptive methods during the study period and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must be non-lactating participants.\n\nExclusion Criteria:\n\n* Non-epithelial origin ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (e.g., germ cell tumors); ovarian tumors of low malignant potential (e.g., borderline tumors);\n* Concurrent use of other cancer neoadjuvant therapies during this study, including but not limited to chemotherapy, radiotherapy, immunotherapy, microbial therapy, traditional Chinese medicine, and other experimental therapies;\n* Hypersensitivity to the active or inactive ingredients of the investigational drug or drugs with similar structure to the investigational drug;\n* Inability to swallow oral medications and any gastrointestinal disorders that may interfere with the absorption and metabolism of study drugs (for Cohort 2);\n* Prior treatment with known or suspected poly (ADP-ribose) polymerase (PARP) inhibitors (for Cohort 2);\n* Presence of symptomatic or uncontrolled brain metastases requiring concurrent treatment;\n* Active or potentially recurrent autoimmune disease; exceptions include: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism caused by autoimmune thyroiditis requiring only stable dose hormone replacement therapy; Type 1 diabetes requiring only stable dose insulin replacement therapy;\n* Major surgery within 3 weeks before study initiation, or incomplete recovery from surgery;\n* History of organ transplantation, autologous\u002Fallogeneic stem cell transplantation;\n* Known or self-reported human immunodeficiency virus (HIV) infection;\n* HBV-DNA positive, HCV-DNA positive (copy number \\>10³);\n* Prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40, etc.), immune cell therapy, or any other treatments targeting tumor immune mechanisms;\n* Live vaccine administered within 4 weeks before first dose, or planned live vaccine administration during the study period;\n* History of other malignancies within the past 3 years, except for cutaneous squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ of the breast, or cervical carcinoma in situ;\n* Prior or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML);\n* Patients who received platelet or red blood cell transfusions within 4 weeks before initiation of study drug treatment;\n* Pregnant, lactating, or patients planning to become pregnant during study treatment;\n* Patients deemed unsuitable for participation in this study by the investigator.","FEMALE",{"count":147,"type":20},50,[23],"This study is a prospective, open-label, multicenter Phase II clinical trial, planning to enroll 50 patients with advanced ovarian cancer. Enrolled participants will be assigned to 2 cohorts based on ECOG performance status and genetic mutation status:\n\nCohort 1: ECOG PS 0 or 1, all-comers population, regardless of BRCA or HRD test results. Treatment: iparomlimab and tuvonralimab (5 mg\u002Fkg, Q3W, D1) + paclitaxel (175 mg\u002Fm², Q3W, D1) + carboplatin (AUC 5-6, Q3W, D1)\u002Fcisplatin (75 mg\u002Fm², Q3W, D1). Planned enrollment: 30 patients.\n\nCohort 2: ECOG PS 2, BRCA1\u002F2 mutation or HRD positive. Treatment: iparomlimab and tuvonralimab (5 mg\u002Fkg, Q3W, D1) + olaparib (300 mg, for 2-3 cycles, bid) + intraperitoneal perfusion (cisplatin, 75 mg\u002Fm², Q3W, D1). Planned enrollment: 20 patients.\n\nNeoadjuvant therapy will be administered for 3 cycles, followed by patient status assessment. Patients with CR\u002FPR\u002FSD will be allowed to undergo surgery, while PD patients will have subsequent treatment strategies determined by the investigator.",[151],"Ovarian Cancers",[153,154,155,79,156],"ovarian cancer","ICIs","Neoadjuvant therapy","olaparib","2026-02-10",{"date":130,"type":33},{"date":160,"type":20},"2026-02-01",{"date":162,"type":20},"2028-12-31",{"name":39,"class":40},{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":4,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":177,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":63},"100599260","phase-2-a-prospective-phase-ii-clinical-study-of-immunotherapy-combined-with-chemotherapy-for-stage-iii-unresectable-non-small-cell-lung-cancer-100599260","NCT07082179","A Prospective Phase II Clinical Study of Immunotherapy Combined With Chemotherapy for Stage III Unresectable Non-small Cell Lung Cancer","The Efficacy and Safety of Iparomlimab and Tuvonralimab Combined With Paclitaxel Polymer Micelles and Platinum (Cisplatin\u002FCarboplatin) in the Treatment of Stage III Unresectable Non-small Cell Lung Cancer","Inclusion Criteria:\n\n* 1\\. Males or females aged 18 to 75 years.\n* 2\\. Histologically or cytologically confirmed squamous or non-squamous (EGFR\u002FALK\u002FROS1 negative) non-small cell lung cancer.\n* 3\\. No prior local treatment (surgery or radiotherapy) or any systemic anti-tumor treatment for the tumor, including cytotoxic therapy, targeted therapy (including tyrosine kinase inhibitors or monoclonal antibodies), cell therapy, immunotherapy, traditional Chinese medicine treatment, or any other investigational drug treatment.\n* 4\\. Patients with unresectable stage III disease (according to the 8th edition AJCC TNM staging for non-small cell lung cancer, T1-2N2-3M0, T3N1-3M0, T4N0-3M0) after multidisciplinary team (MDT) assessment.\n* 5\\. At least one measurable lesion according to RECIST v1.1 criteria, as shown by chest enhanced CT or PET\u002FCT.\n* 6\\. ECOG performance status: 0 or 1.\n* 7\\. The patient is able to tolerate induction therapy and surgery. Radical surgical resection and systematic lymph node dissection are recommended, provided that surgical margins can be ensured and the patient's general condition is taken into account.\n* 8\\. Expected survival of ≥12 months.\n* 9\\. Major organ and marrow function meet the following requirements:\n* Hematologic tests (no transfusions or blood products, no use of G-CSF or other hematopoietic growth factors within 14 days):\n\n  1. Hematologic indices: Absolute neutrophil count ≥1.5×10⁹\u002FL, platelets ≥100×10⁹\u002FL, hemoglobin ≥90 g\u002FL.\n  2. Liver and kidney function indices: Total bilirubin ≤1.5×ULN, ALT\u002FAST ≤2.5×ULN; creatinine ≤1.5×ULN, or creatinine clearance ≥60 mL\u002Fmin; urine routine test with proteinuria less than 2+. If the patient has proteinuria ≥2+ at baseline, a 24-hour urine collection should be performed to demonstrate that the 24-hour urine protein quantification is ≤1 g.\n  3. Coagulation function indices: INR ≤1.5; activated partial thromboplastin time (APTT) ≤1.5×ULN.\n  4. Endocrine system: Thyroid-stimulating hormone (TSH) within normal limits. Note: If TSH is not within the normal range at baseline, but T3 and free T4 are within the normal range, the subject is still eligible.\n* Cardiopulmonary function meets the following requirements:\n\n  1. Pulmonary function indices: FEV1.0 \\> 1.0 L or FEV% \\> 50%.\n  2. Cardiac function indices: Electrocardiogram (ECG) QTc interval \\> 480 msec (QTc interval calculated using the Fridericia formula).\n* 10\\. Women of childbearing potential must have used reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug. For men, they must agree to use appropriate contraception during the trial and for 8 weeks after the last administration of the investigational drug or have undergone surgical sterilization.\n* 11\\. The subject voluntarily agrees to participate in this study, signs the informed consent form, is compliant, and is willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Presence of contraindications to immunotherapy (including long-term use of corticosteroids, history of radiation pneumonitis, etc.).\n* 2\\. History of severe allergy to paclitaxel, docetaxel, platinum agents, or their prophylactic medications.\n* 3\\. Any unstable systemic disease, including active infection, uncontrolled hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg despite optimal medical therapy), unstable angina, angina attack within the past 3 months, liver disease requiring medication, kidney disease, or metabolic disease.\n* 4\\. Received live vaccine within 28 days prior to treatment.\n* 5\\. Previously received radiotherapy, chemotherapy, targeted therapy, or immunotherapy.\n* 6\\. Active autoimmune disease (such as vitiligo, psoriasis, hypothyroidism requiring hormone replacement therapy, etc.).\n* 7\\. Patients with active hepatitis B or C, HIV patients, active tuberculosis, etc.\n* 8\\. Active infection requiring antimicrobial treatment (e.g., requiring antibiotics, antiviral agents, antifungal agents).\n* 9\\. Known history of allogeneic organ transplantation and known history of hematopoietic stem cell transplantation.\n* 10\\. Patients with interstitial lung disease or a history of interstitial pneumonia.\n* 11\\. History of drug abuse or mental disorders that cannot be controlled.\n* 12\\. Previous or concurrent other untreated malignancies, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer.\n* 13\\. Pregnant or breastfeeding women; patients of childbearing potential who are unwilling or unable to take effective contraceptive measures.\n* 14\\. Other situations that the investigator judges may affect the conduct of the clinical study or the determination of study results.",{"count":172,"type":20},33,[23],"This study is a prospective, multicenter, open-label, single-arm Phase II clinical trial. The study recruits patients with stage III unresectable non-small cell lung cancer according to the 8th edition of the AJCC\u002FUICC staging system. It aims to observe and evaluate the efficacy and safety of anti-PD-1\u002FCTLA-4 antibody in combination with paclitaxel polymer micelles and platinum-based therapy for stage III unresectable non-small cell lung cancer.",[176],"NSCLC",[178],"Iparomlimab and Tuvonralimab,Chemotherapy, unresectable non-small cell lung cancer","2026-02-09",{"date":181,"type":33},"2026-02-11",{"date":183,"type":33},"2025-09-04",{"date":185,"type":20},"2028-12",{"name":39,"class":40},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":195,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},"100616897","phase-2-disitamab-vedotin-combined-with-platinum-and-bevacizumab-as-first-line-and-maintenance-therapy-for-her2-expressing-hrd-negative-high-risk-ovarian-cancer-a-multicenter-non-randomized-single-arm-phase-ii-clinical-study-100616897","NCT07311577","Disitamab Vedotin Combined With Platinum and Bevacizumab as First-Line and Maintenance Therapy for HER2-Expressing, HRD-Negative High-Risk Ovarian Cancer: A Multicenter, Non-Randomized, Single-Arm Phase II Clinical Study","Inclusion Criteria:\n\n* Voluntary participation with written informed consent.\n* Age 18-75 years.\n* Expected survival ≥ 12 weeks.\n* Histologically\u002Fcytologically confirmed advanced ovarian carcinoma (FIGO Stage III-IV).\n* HRD-negative status per local assessment.\n* High-risk features: macroscopic residual disease after primary cytoreductive surgery for Stage III; prior neoadjuvant chemotherapy; or Stage IV disease.\n* ≥ 1 RECIST v1.1 measurable lesion (long-axis ≥ 10 mm by spiral CT or ≥ 15 mm short-axis for lymph nodes).\n* HER2 expression documented locally (IHC 1+, 2+, or 3+); archival or fresh tumor tissue (paraffin block or unstained slides) must be available for central confirmation.\n* ECOG performance status 0-1.\n* Adequate organ function within 14 days before enrolment (no transfusion\u002Fhaematinics\u002FG-CSF allowed):\n\nHaematology\n\n1. Hb ≥ 90 g\u002FL\n2. WBC ≥ 3 × 10⁹\u002FL\n3. ANC ≥ 1.5 × 10⁹\u002FL\n4. PLT ≥ 90 × 10⁹\u002FL Biochemistry\n\na) TBIL ≤ 1.5 × ULN b) ALT\u002FAST\u002FALP ≤ 3 × ULN (≤ 5 × ULN if liver metastases) c) Serum creatinine ≤ 1.5 × ULN or CrCl ≥ 60 mL\u002Fmin (Cockcroft-Gault)\n\n* Urinalysis: dipstick proteinuria \\\u003C 2+ or 24-h urine protein \\\u003C 1 g.\n* Cardiac function: NYHA class \\\u003C III and LVEF ≥ 50 % by echocardiography. -\n* Women must be surgically sterile, post-menopausal, or use an approved contraceptive method from screening until 6 months after the last dose; serum pregnancy test negative within 7 days of first dose and not breastfeeding.\n* Able and willing to comply with all study and follow-up procedures.\n\nExclusion Criteria:\n\n* Non-high-risk histologic sub-types of ovarian carcinoma.\n* CNS metastases and\u002For carcinomatous meningitis. -\n* Requirement for parenteral hydration\u002Fnutrition OR clinical\u002Fradiologic evidence of partial bowel obstruction or perforation.\n* ≥ Grade-2 peripheral neuropathy. -\n* Active bleeding or high bleeding-risk conditions (e.g., known coagulopathy, tumour encasing major vessels).\n* Interval between cytoreductive surgery and first bevacizumab dose \\\u003C 28 days.\n* Concurrent malignancy or history of another primary malignancy within 5 years (except adequately treated in-situ cervix cancer, basal- or squamous-cell skin cancer).\n* Major surgery within 4 weeks before first study dose and not fully recovered.\n* Symptomatic or medically-requiring large-volume pleural effusion or ascites. - Live-attenuated vaccine within 30 days before first dose or planned during study.\n* Significant arterial\u002Fvenous thrombo-embolic or cerebro-cardiovascular event within 12 months before screening (e.g., DVT, PE, cerebral infarction, intracranial haemorrhage, MI); asymptomatic calf-muscle DVT not needing intervention or lacunar infarct without sequelae are allowed.\n* Uncontrolled systemic diseases judged by investigator: diabetes, liver cirrhosis Child-Pugh B\u002FC, interstitial pneumonitis, severe COPD, etc.\n* Clinically-relevant cardiovascular disorders:\n\n  1. PR interval \\> 0.24 s or 2nd\u002F3rd-degree AV block.\n  2. Uncontrolled hypertension (SBP \\> 150 mmHg or DBP \\> 90 mmHg).\n  3. MI, unstable angina or significant arrhythmia \\\u003C 6 months before enrolment.\n  4. NYHA class ≥ II congestive heart failure.\n  5. Serious arrhythmia requiring anti-arrhythmic therapy.\n  6. ≥ Stage-II peripheral vascular disease (except transient ischaemia \\\u003C 24 h without permanent deficit and no surgery).\n  7. Cerebrovascular accident within 6 months.\n* Severe infection within 4 weeks before first dose (IV antibiotics\u002Fantifungals\u002F antivirals required) or unexplained fever \\> 38.5 °C during screening; major surgery within 3 weeks.\n* Active autoimmune or immunodeficiency disorders (e.g., autoimmune hepatitis, interstitial pneumonia, uveitis, RA, IBD, hypophysitis, vasculitis, nephritis). Exceptions: stable hypothyroidism on replacement, type-1 diabetes well controlled with insulin.\n* Autoimmune disease requiring systemic immunosuppressive\u002Fimmunomodulatory therapy within 2 years before first dose (stable replacement therapy with thyroxine, insulin or physiological corticosteroids permitted).\n* Active or poorly controlled infection, including:\n\n  1. HIV positive (HIV-1\u002F2 antibody).\n  2. Active hepatitis B (HBsAg positive or HBV DNA \\> 2 000 IU\u002FmL with abnormal LFT).\n  3. Active hepatitis C (HCV antibody positive or HCV RNA ≥ 10³ copies\u002FmL with abnormal LFT).\n  4. Active tuberculosis.\n  5. Other uncontrolled infection \\> CTCAE v5.0 grade 2.\n* History of other malignancy within 5 years (except adequately treated in-situ cervical cancer or basal\u002Fsquamous-cell skin cancer). -\n* Concurrent participation in another interventional clinical trial or investigational agent\u002Fdevice within 4 weeks before first dose. -\n* Known hypersensitivity or intolerance to study drugs or their excipients. -\n* History of substance abuse that cannot be abstained from, or any psychiatric disorder that may interfere with compliance.\n\nAny other condition that, in the investigator's opinion, could increase risk or preclude safe completion of the protocol.",{"count":194,"type":20},43,[23],"This is a prospective, multicenter, phase II study designed to evaluate the efficacy and safety of disitamab vedotin combined with platinum plus bevacizumab as first-line therapy for HER2-expressing, HRD-negative high-risk ovarian cancer. Forty-three patients with pathologically confirmed HRD-negative high-risk ovarian cancer will be enrolled. After enrollment, patients will receive disitamab vedotin plus platinum and bevacizumab as first-line and maintenance treatment.\n\nFirst-line phase:\n\nCarboplatin AUC 5 intravenously on Day 1 every 21 days over 1 h ,Bevacizumab 7.5-15 mg\u002Fkg intravenously on Day 1 every 21 days over 30-90 min.\n\nMaintenance phase:\n\nPatients who achieve response (CR or PR) will continue disitamab vedotin monotherapy plus bevacizumab (investigator decides whether to continue disitamab vedotin and for how long).\n\nMaintenance duration: bevacizumab until disease progression or up to 22 cycles; disitamab vedotin up to 6 months (8 cycles).",[198,199],"Ovarian Cancer Metastatic","Ovarian Cancer Metastatic Recurrent",[201,202,203],"RC48","HRD-Negative High-Risk Ovarian Cancer","HER2-expressing","2025-12-29",{"date":206,"type":33},"2025-12-31",{"date":208,"type":20},"2026-01-01",{"date":210,"type":20},"2028-12-30",{"name":39,"class":40},2,{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":123,"enrollmentInfo":219,"targetDuration":4,"studyType":221,"phases":4,"briefSummary":222,"conditions":223,"keywords":225,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":63},"100509373","prospective-study-for-molecular-biomarkers-and-spatial-transcriptomics-of-nasopharyngeal-carcinoma-100509373","NCT05912582","Prospective Study for Molecular Biomarkers and Spatial Transcriptomics of Nasopharyngeal Carcinoma","Inclusion Criteria:\n\n1. Patients with newly histologically confirmed nasopharyngeal carcinoma\n2. No evidence of distant metastasis (M0)\n3. Written informed consent\n\nExclusion Criteria:\n\nTreatment with palliative intent",{"count":220,"type":20},60,"OBSERVATIONAL","This clinical research aims to explore potential biomarkers and validate molecular signatures' predictive and prognostic value in nasopharyngeal carcinoma.",[224],"Nasopharyngeal Carcinoma",[224,226,227],"Biomarker","Spatial Transcriptomics","2025-12-19",{"date":230,"type":33},"2025-12-26",{"date":232,"type":20},"2025-12-25",{"date":234,"type":20},"2028-12-25",{"name":39,"class":40},{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":63},"100615003","phase-2-stereotactic-body-radiotherapy-with-sequential-iparomlimab-and-tuvonralimab-ql1706--chemotherapy-as-neoadjuvant-therapy-in-patients-with-resectable-non-small-cell-lung-cancer-in-china-lung-nanjing01-a-single-arm-single-centre-phase-2-trial-100615003","NCT07286942","Stereotactic Body Radiotherapy With Sequential Iparomlimab and Tuvonralimab (QL1706) + Chemotherapy as Neoadjuvant Therapy in Patients With Resectable Non-small-cell Lung Cancer in China (LUNG-Nanjing01): a Single-arm, Single-centre, Phase 2 Trial","Inclusion Criteria:\n\n1. Voluntarily participates in the study and provides written informed consent;\n2. Aged 18-75 years, with no restriction on sex;\n3. Histologically or cytologically confirmed diagnosis of non-small-cell lung cancer (NSCLC);\n4. Has not received prior systemic therapy and is willing to undergo neoadjuvant treatment for stage cⅡ-Ⅲ (N2a) disease, according to the 9th edition of the AJCC staging system (Appendix 1);\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (see Appendix 2 for scoring criteria);\n6. Considered by the thoracic surgeon to have adequate pulmonary reserve to tolerate the planned lung resection;\n7. Availability of tumor tissue prior to enrollment for pathological confirmation of EGFR\u002FALK wild-type status and PD-L1 expression assessment;\n8. No significant hematologic, cardiac, pulmonary, hepatic, renal, or immunologic dysfunction, with the following laboratory parameters meeting the specified criteria:\n\n   * Bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count ≥80×10⁹\u002FL; hemoglobin ≥9 g\u002FdL;\n   * Liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5× ULN;\n   * Renal function: serum creatinine ≤1.5× ULN or creatinine clearance ≥60 mL\u002Fmin; blood urea nitrogen ≤200 mg\u002FL;\n9. Women of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose of study treatment.\n\nExclusion Criteria:\n\n* 1\\. Presence of locally advanced unresectable or metastatic disease. Unresectable disease is defined according to the 2019 Multidisciplinary Consensus on Stage III Non-Small-Cell Lung Cancer (NSCLC), including certain stage IIIA and IIIB cases and all stage IIIC cases. Typically, this includes N2 disease with a single mediastinal lymph node ≥3 cm in short axis or multiple fused lymph nodes (≥2 cm in short axis on CT), as well as T4 lesions invading the esophagus, heart, aorta, or pulmonary veins, and all N3 disease.\n\n  2\\. Superior sulcus (Pancoast) NSCLC, large-cell neuroendocrine carcinoma (LCNEC), or sarcomatoid carcinoma.\n\n  3\\. Known EGFR-sensitive mutations or ALK rearrangements (non-squamous participants must have confirmed EGFR and ALK mutation status).\n\n  4\\. Prior systemic anticancer therapy for early-stage NSCLC, including investigational agents.\n\n  5\\. Active infection, or unexplained fever \\>38.5 °C within 2 weeks prior to screening (participants with tumor-related fever, as judged by the investigator, may be enrolled).\n\n  6\\. Male or female participants of reproductive potential who are unwilling to use effective contraception during the study; pregnant or breastfeeding women.\n\n  7\\. Any condition that, in the opinion of the investigator, could interfere with study participation or completion, including severe comorbidities (including psychiatric disorders) requiring concurrent treatment, or family or social factors that may compromise participant safety or data integrity.",{"count":243,"type":20},24,[23],"The primary objective of this study is to evaluate whether neoadjuvant SBRT as an immunomodulator in combination with apalolimab and toripalimab (QL1706) plus chemotherapy improves the pathological complete response (pCR) rate in patients with resectable stage IIA-IIIB LUAD. The secondary objectives include major pathological response (MPR), disease-free survival (DFS), R0 resection rate, the feasibility and safety. Moreover, the potential predictors for pathological response also will be explored.",[176,247],"NSCLC (Non-small Cell Lung Cancer)",[176,249,250],"SBRT","neoadjuvant","2025-12-03",{"date":253,"type":33},"2025-12-16",{"date":255,"type":20},"2025-12-18",{"date":257,"type":20},"2029-12-18",{"name":39,"class":40},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":123,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100597041","phase-2-a-study-on-immunotherapy-combined-with-radiotherapy-for-esophagogastric-junctiongastric-adenocarcinoma-100597041","NCT07053332","A Study on Immunotherapy Combined With Radiotherapy for Esophagogastric Junction\u002FGastric Adenocarcinoma","A Single-arm, Prospective Phase II Clinical Study of Neoadjuvant PD-1\u002FCTLA-4 Combination Antibody With Low-dose Radiotherapy in Resectable dMMR\u002FMSI-H Esophagogastric Junction\u002FGastric Adenocarcinoma.","Inclusion Criteria:\n\n1. Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and agree to follow-up;\n2. Patients with esophagogastric junction\u002Fgastric adenocarcinoma (Siewert type II\u002FIII) confirmed by endoscopic pathology (note: pathologies from other hospitals must be reviewed at our hospital), with dMMR\u002FMSI-H status confirmed by immunohistochemistry or genetic testing;\n3. Based on endoscopic, CT, MRI, or PET-CT findings, AJCC 8th edition staging is cT1-2N1-3M0 or T3-T4aN0-3M0;\n4. Age between 18 and 80 years, inclusive of both 18 and 80, both genders are eligible;\n5. ECOG PS score of 0-1;\n6. Presence of measurable and\u002For non-measurable lesions as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1);\n7. No prior systemic anti-tumor treatment (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted therapy, immunotherapy, biologic therapy, local therapy, or investigational drugs);\n8. The function of major organs must meet the following criteria (no blood components or cell growth factors allowed within 2 weeks before screening):\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL;\n   * Platelets ≥ 100 × 10⁹\u002FL;\n   * Hemoglobin ≥ 9 g\u002FdL;\n   * Serum albumin ≥ 2.8 g\u002FdL;\n   * Total bilirubin ≤ 1.5 × ULN, ALT, AST, and\u002For ALP ≤ 2.5 × ULN;\n   * Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin (calculated using the Cockcroft-Gault formula);\n   * International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (patients receiving stable-dose anticoagulation therapy such as low-molecular-weight heparin or warfarin with INR within the expected therapeutic range may be enrolled).\n\nFemales of childbearing potential should undergo a urine or serum pregnancy test within 72 hours prior to the first dose of study drug and must have a negative result. They must also agree to use effective contraception during the study period and for 5 months after the last dose. Male participants whose partners are of childbearing potential must also use effective contraception during the study period and for 7 months after the last dose.\n\nExclusion Criteria:\n\n1. History of surgery for gastric or gastroesophageal junction tumor;\n2. Immunohistochemistry or genetic testing shows pMMR, MSI-L, or MSS;\n3. High risk of gastrointestinal bleeding or perforation;\n4. Poor nutritional status, BMI \\\u003C 18.5 kg\u002Fm², or PG-SGA score ≥ 9;\n5. Major surgery or serious trauma within 4 weeks prior to the first use of the study drug;\n6. Presence of uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\n7. Previously received or is currently receiving any of the following treatments: anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy;\n8. Received any investigational drug within 4 weeks prior to the first use of the study drug;\n9. Requires systemic corticosteroids (more than 10 mg\u002Fday prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug, except for local inflammation of the esophagus\u002Fstomach and corticosteroid use for allergy prevention or nausea\u002Fvomiting control. Special circumstances require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacement at doses \\>10 mg\u002Fday prednisone equivalent are allowed;\n10. Has received an anticancer vaccine or received a live vaccine within 4 weeks prior to the first administration of the study drug;\n11. Has any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism), except for vitiligo or resolved childhood asthma\u002Fallergy that does not require intervention in adulthood. Patients on stable-dose thyroid hormone replacement for autoimmune hypothyroidism and those on stable-dose insulin for type I diabetes mellitus may be included;\n12. History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation;\n13. Any condition requiring systemic corticosteroid treatment (higher than 10 mg\u002Fday prednisone or equivalent) or other immunosuppressive therapy within 14 days before treatment initiation (except for the following situations: locally applied, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; short-term (≤7 days) prophylactic use of corticosteroids (e.g., for contrast agent allergy prevention) or for non-autoimmune conditions (e.g., delayed hypersensitivity reactions due to allergen exposure));\n14. Presence of uncontrolled cardiac symptoms or diseases such as (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within 1 year, or (4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;\n15. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, or infectious complications; baseline chest imaging suggests active pulmonary infection; signs or symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, except for prophylactic antibiotic use;\n16. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases;\n17. Evidence of active tuberculosis infection by medical history or CT findings, or history of active tuberculosis within 1 year prior to enrollment, or history of active tuberculosis more than 1 year ago without proper treatment;\n18. Active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 10⁴ copies\u002FmL) or hepatitis C (anti-HCV positive and HCV-RNA above the lower limit of detection of the assay method);\n19. Laboratory abnormalities in sodium, potassium, or calcium levels greater than Grade 1 within 2 weeks prior to enrollment, which cannot be corrected after treatment;\n20. Known allergy, hypersensitivity, or contraindication to macromolecular protein preparations, PD-1 components, paclitaxel, capecitabine, or any excipients in their formulations;\n21. History of any other malignancy, except for low-risk malignancies with low metastasis and mortality risk (5-year survival rate \\>90%), such as adequately treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;\n22. Pregnant or lactating women; fertile subjects unwilling or unable to take effective contraceptive measures;\n23. The investigator determines that the subject has other factors likely to result in premature termination of the study, such as other serious illnesses (including mental illness) requiring concurrent treatment, recent serious illnesses (e.g., myocardial infarction, cerebrovascular accident) with high recurrence risk, severely abnormal laboratory values, family or social factors that may affect the subject's safety or data collection from the trial.",{"count":267,"type":20},20,[23],"A single-arm, prospective phase II clinical study of neoadjuvant PD-1\u002FCTLA-4 combination antibody with low-dose radiotherapy in resectable dMMR\u002FMSI-H esophagogastric junction\u002Fgastric adenocarcinoma.",[271],"Esophagogastric Junction\u002FGastric Adenocarcinoma",[273],"Iparomlimab and Tuvonralimab，Radiotherapy，esophagogastric junction\u002Fgastric adenocarcinoma","2025-06-26",{"date":276,"type":33},"2025-07-08",{"date":278,"type":20},"2025-07",{"date":280,"type":20},"2029-08-12",{"name":39,"class":40},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":21,"phases":291,"briefSummary":292,"conditions":293,"keywords":295,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100593706","phase-2-phase-ii-study-of-platinum-cisplatincarboplatinand-polymeric-micelles-paclitaxelpm-pac-with-ivonescimab-in-first-line-metastatic-squamous-nsclc-100593706","NCT07009925","Phase II Study of Platinum (Cisplatin\u002FCarboplatin)and Polymeric Micelles Paclitaxel(Pm-Pac) With Ivonescimab in First Line Metastatic Squamous NSCLC.","Ivonescimab Combined With Polymeric Micelles Paclitaxel(Pm-Pac) and Platinum (Cisplatin\u002FCarboplatin) as First-line Treatment for Patients With Advanced Squamous NSCLC: A Multicenter, Open-label, Single-arm Clinical Study.","Inclusion Criteria:\n\n1. Written informed consent must be signed before implementing any trial-related procedures;\n2. Age ≥18 years old;\n3. Patients with histologically or cytologically confirmed metastatic or recurrent (stage IV) squamous NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging), inoperable or inappropriate for radical concurrent chemoradiotherapy, and without previous systemic treatment；. Patients with mixed histology (example adenosquamous) are allowed if there is squamous component in the specimen. PD-L1 immunohistochemical results is required before enrollment.\n\n5.According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one measurable lesion.\n\n6.Have not received any previous systemic antitumor therapy for advanced\u002Fmetastatic diseases. Participants who have previously received platinum-based adjuvant\u002Fneoadjuvant chemotherapy, or radical chemoradiotherapy for advanced disease are allowed to enroll if the interval between disease progression or recurrence and the end of the last chemotherapy treatment is at least 6 months.\n\n7.ECOG score: 0-1 8.Expected survival time \\> 3 months 9.Normal organ function, patients should meet the following laboratory indicators:\n\n1. Blood routine test should meet the following criteria (no blood transfusion, no use of blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors within 7 days before blood routine test); White blood cell count ≥3.0x10\\^9\u002FL, absolute neutrophil count (ANC) ≥1.5x10\\^9\u002FL，Platelet count ≥100×10\\^9\u002FL Hemoglobin \\>9g\u002FdL. If patients receive blood component transfusion (red blood cells, platelets, etc.) during the screening period, blood routine test should be performed again at an interval of 1 week to meet the above criteria before continuing screening.\n2. Blood biochemical examination must meet the following criteria: Total bilirubin ≤1.5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) ≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for patients with liver metastases, and ALP≤10×ULN for patients with bone metastases); Serum creatinine ≤1.5 times ULN and creatinine clearance (calculated using Cockcroft-Gault formula) ≥60 ml\u002Fmin；\n3. Normal coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) ≤1.5 times ULN;\n4. Normal thyroid function, defined as thyroid stimulating hormone (TSH) within the normal range. Subjects with baseline TSH beyond the normal range, but total T3 (or FT3) and FT4 are within the normal range can also be enrolled;\n5. Myocardial zymogram within the normal range (if the investor judges that the simple laboratory result is not of clinical significance, the patient is allowed to be included); 10.For female patients of childbearing age, a negative urine or serum pregnancy test should be performed within 3 days before the first study drug administration (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is requested. Female patients who are not of childbearing age are defined as those who have been postmenopausal for at least 1 year or have undergone surgical sterilization or hysterectomy; 11.If there is a risk of conception, all patients (male or female) are required to use contraception throughout the treatment period until 180 days after the last study drug administration.\n\nExclusion Criteria:\n\n1. Currently participating in interventional clinical research treatment;\n2. Has non-squamous histology NSCLC. Mixed tumors will be categorized by the predominant cell type; if small cell elements are present, the subject is ineligible; for non-small cell histology if there is any squamous element is present (example adenosquamous), the subject is eligible; the squamous element does not have to be predominant.\n3. Previously received immunotherapy, including immune checkpoint inhibitors (such as anti-PD-1 \u002FL1 antibodies, anti-CTLA-4 antibodies, anti-LAG-3 antibodies, etc.), immune checkpoint agonists (such as: Subjects of ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, etc., any treatment targeting the immune mechanism of tumor action;\n4. known allergic or hypersensitive reactions to any investigational drug or any excipients thereof;\n5. Have a history of severe bleeding or coagulopathy; Clinically significant bleeding symptoms, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or spitting up ≥1 TSP of blood or small blood clots or only coughing up blood with no sputum, allowing inclusion of blood in the sputum), nasal bleeding (excluding nosebleed and retractive rhinorrhea) within 1 month before first administration; Imaging during the screening period showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the researchers determined that entering the study would cause bleeding risk. Central, squamous non-small cell lung cancer with cavities and a higher risk of bleeding as determined by the investigators; Received continuous antiplatelet or anticoagulant therapy within 10 days prior to initial administration;\n6. Tumor invasion of surrounding important organs and blood vessels (such as aorta, heart and pericardium, superior vena cava, trachea, esophagus, etc.) or esophagotracheal fistula or esophagopleural fistula risk;\n7. Subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (subjects who do not require drainage effusion or whose frequency of drainage is less than once per month can be enrolled);\n8. Patients with symptomatic brain metastases, meningeal metastases, or spinal cord compression;\n9. There is a history or current presence of non-infectious pneumonia\u002Finterstitial lung disease requiring systemic glucocorticoid therapy;\n10. Serious comorbidities such as a history of severe lung or heart disease, any arterial thrombosis, embolism, or ischemia within 6 months prior to treatment, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within the 3 months prior to enrollment (implantable intravenous port or catheter-derived thrombosis, or superficial venous thrombosis was not considered \"severe\" thromboembolism);\n11. History of autoimmune diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Patients with autoimmune related hypothyroidism receiving stable dose thyroid hormone replacement therapy were eligible to participate in the study. Patients with controlled type 1 diabetes following a stable insulin regimen were eligible to participate in the study.\n12. Active systemic infections, including tuberculosis (clinical diagnosis including clinical history, physical examination and imaging findings, and TB testing based on local medical practice), hepatitis B (known to be positive for HBV surface antigen (HBsAg), HBV DNA ≥1000cps\u002Fml or the lower limit of its reference value), hepatitis C or human immunodeficiency virus (HIV antibody positive);\n13. A known mental illness or substance abuse condition that may affect compliance with the test requirements;\n14. There is a medical history, disease, treatment, or abnormal laboratory result that could interfere with the test results or prevent the subject from fully participating in the study, or the investigator believes that participation in the study is not in the subject's best interest.",{"count":290,"type":20},38,[23],"This is a prospective, single-arm, multi-center, phase Ⅱ trial to evaluate the efficacy and safety of Polymeric Micelles paclitaxel(pm-Pac), platinum (cisplatin\u002Fcarboplatin) in combination with Ivonescimab as first-line treatment in metastatic squamous NSCLC patients.",[294],"Squamous Cell Lung Cancer",[296,297,298,299,300],"Ivonescimab","Polymeric Micelles paclitaxel","metastatic squamous cell lung cancer","Treatment Outcome","safety","2025-05-30",{"date":303,"type":33},"2025-06-08",{"date":305,"type":20},"2025-06",{"date":307,"type":20},"2028-05",{"name":39,"class":40},{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":316,"targetDuration":4,"studyType":21,"phases":318,"briefSummary":319,"conditions":320,"keywords":325,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":332,"locationsCount":63},"100581294","phase-2-benmelstobart-anlotinib-chemo-for-neoadjuvant-oral-cancer-100581294","NCT06848439","Benmelstobart-Anlotinib-Chemo for Neoadjuvant Oral Cancer","A Phase II Study of Benmelstobart Combined With Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients With Locally Advanced Oral Cancer","Inclusion Criteria:\n\n* Potential subjects must meet all of the following criteria to be eligible for inclusion in this study:\n* Age 18-75 years;\n* ECOG PS score of 0-1;\n* Pathologically confirmed untreated oral squamous cell carcinoma patients, classified as stage III-IVb according to the AJCC (8th edition) staging system;\n* Women of childbearing potential must have taken reliable contraceptive measures or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized. For men, they must agree to use appropriate contraceptive methods during the trial and for 8 weeks after the last dose of the study drug, or be surgically sterilized;\n\nSigned informed consent form by the participant, with good compliance.\n\nExclusion Criteria:\n\nPotential subjects must be excluded from the study if they meet any of the following criteria:\n\n* Prior treatment with PD-1\u002FPD-L1\u002FCTLA-4 antibodies.\n* Tumor invasion of major blood vessels.\n* Requirement for systemic corticosteroid therapy (\\>10 mg prednisone equivalent per day) or other immunosuppressive treatment within 14 days before administration or during treatment. Inhaled or topical steroids and adrenal corticosteroid replacement therapy at ≤10 mg\u002Fday prednisone equivalent are allowed in the absence of active autoimmune disease.\n* History of any active immune-related or autoimmune disease, or a known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Active or uncontrolled severe infection (≥ Grade 2 NCI CTCAE v5.0 infection) within 4 weeks prior to enrollment.\n* Coagulation disorders (INR \\>1.5, prothrombin time (PT) \\> ULN + 4 sec, or APTT \\>1.5 × ULN), a tendency for bleeding, or undergoing thrombolytic or anticoagulant therapy. Note: The use of low-dose heparin (adult daily dose of 6,000-12,000 U) or low-dose aspirin (daily dose ≤100 mg) for prophylactic purposes is allowed if INR ≤1.5.\n* Imaging evidence of tumor invasion of major blood vessels or tumors highly likely to invade major blood vessels and cause fatal hemorrhage during the study, as assessed by the investigator.\n* Any signs or history of a bleeding tendency, regardless of severity. Patients with bleeding or hemorrhagic events (≥CTCAE Grade 2) within 4 weeks prior to randomization, or those with unhealed wounds, ulcers, or fractures.\n* Major organ dysfunction:\n\nHematological abnormalities (without correction via blood transfusion, blood products, G-CSF, or other hematopoietic stimulants within 14 days):\n\n1. Hemoglobin (HB) \\\u003C90 g\u002FL.\n2. Absolute neutrophil count (ANC) \\\u003C1.5 × 10⁹\u002FL.\n3. Platelets (PLT) \\\u003C100 × 10⁹\u002FL.\n\nBiochemical abnormalities:\n\n1. Total bilirubin (TBIL) \\>1.5 × ULN.\n2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>2.5 × ULN.\n3. Serum creatinine (Cr) \\>1.5 × ULN or creatinine clearance rate (CCr) \\\u003C60 mL\u002Fmin. Doppler ultrasound abnormalities: Left ventricular ejection fraction (LVEF) \\\u003C60%.\n\nThyroid function abnormalities: TSH \\> ULN with abnormal T3 and T4 levels. Renal dysfunction: Urine protein ≥++ on urinalysis or confirmed 24-hour urine protein level ≥1.0 g.\n\n* History of myocardial ischemia (≥Grade I), myocardial infarction, arrhythmia (QTc ≥480 ms), or ≥Grade 2 congestive heart failure (NYHA classification) within 6 months before enrollment.\n* Diagnosis of another malignancy within 3 years prior to enrollment.\n* Any severe and\u002For uncontrolled disease, including:\n\n  1. Poorly controlled hypertension (systolic BP ≥150 mmHg or diastolic BP ≥100 mmHg), history of myocardial ischemia (≥Grade I), myocardial infarction, arrhythmia (QT interval ≥430 ms), or heart failure (NYHA Grade I).\n  2. Active or uncontrolled severe infection.\n  3. Liver cirrhosis, decompensated liver disease, or active hepatitis (HBV or HCV).\n  4. Poorly controlled diabetes (fasting blood glucose (FBG) \\>10 mmol\u002FL).\n  5. Urine protein ≥2+ and confirmed 24-hour urine protein \\>1.0 g.\n* Presence of long-term unhealed wounds or fractures.\n* Lung hemorrhage (\\>Grade 1 NCI CTC AE v4.0) within 4 weeks before enrollment or hemorrhage in other areas (\\>Grade 2 NCI CTC AE v4.0) within 4 weeks before enrollment. Patients with a tendency to bleed (e.g., active gastrointestinal ulcers) or those receiving thrombolytic or anticoagulant therapy (e.g., warfarin, heparin, or similar agents).\n* History of gastrointestinal perforation and\u002For fistula within 6 months before treatment initiation; or history of arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.\n* Imaging evidence of tumor invasion of major blood vessels or tumors highly likely to invade major blood vessels and cause fatal hemorrhage, as assessed by the investigator.\n* Clinically significant ascites, including any detectable ascites on physical examination or ascites requiring treatment. Patients with only mild asymptomatic ascites detected by imaging may be enrolled.\n* Uncontrolled metabolic disorders or other non-malignant systemic diseases or conditions secondary to cancer that may pose a high medical risk and\u002For create uncertainty in survival assessment.\n* Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment.\n* History of substance abuse that cannot be discontinued or the presence of psychiatric disorders.\n* Any other conditions determined by the investigator that may pose serious risks to patient safety, confound study results, or affect the patient's ability to complete the study.",{"count":317,"type":20},26,[23],"Exploring the Safety and Efficacy of Benmelstobart Combined with Anlotinib and Chemotherapy as Neoadjuvant Therapy Followed by Surgery and Postoperative Radiotherapy in Patients with Locally Advanced Oral Cancer\n\nThis is a single-center, Phase II study targeting patients with stage III-IVb locally advanced oral squamous cell carcinoma who meet the inclusion and exclusion criteria. The neoadjuvant therapy consists of Benmelstobart combined with Anlotinib and chemotherapy for 3 cycles (21 days per cycle). Surgery is performed within 2 weeks after completing neoadjuvant therapy. Postoperative adjuvant treatment is selected based on pathological grading:\n\nGroup A (Pathological Complete Response, pCR): Postoperative radiotherapy (RT) alone: 40Gy\u002F5 weeks.\n\nGroup B (Major Pathological Response, MPR): Postoperative radiotherapy (RT) alone: 50Gy\u002F5 weeks.\n\nGroup C (Partial Pathological Response\u002FNo Pathological Response):\n\nLow-to-intermediate risk patients (no extracapsular nodal extension and negative margins): RT: 60Gy\u002F6 weeks.\n\nHigh-risk patients (extracapsular nodal extension and\u002For positive margins): Concurrent chemoradiotherapy (CCRT): 60-66Gy\u002F6-6.6 weeks + Cisplatin: 60mg\u002Fm² every 3 weeks, 2-3 cycles.\n\nAdditionally, all patients will receive adjuvant Benmelstobart 3-4 weeks after surgery, followed by Benmelstobart maintenance therapy (total treatment duration of 1 year).",[321,322,323,324],"Mouth Neoplasms","Neoadjuvant Therapy","Immunotherapy","Molecular Targeted Therapy",[321,155,323,324],"2025-05-27",{"date":328,"type":33},"2025-05-31",{"date":330,"type":20},"2025-06-15",{"date":162,"type":20},{"name":39,"class":40},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":123,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":63},"100591836","phase-2-adebrelimab-with-chemoradiotherapy-and-surgery-for-ggej-100591836","NCT06985602","Adebrelimab With Chemoradiotherapy and Surgery for G\u002FGEJ","Adebrelimab Combined With Chemoradiotherapy Followed by Surgery for Locally Advanced or Limited Metastatic Gastric\u002F Esophagogastric Junction Adenocarcinoma.","Inclusion Criteria:\n\n1. Pathologically confirmed esophagogastric junction (EGJ)\u002Fgastric adenocarcinoma.\n2. Patients with locally advanced disease (AJCC staging T4b or N2 fusion metastasis) or limited metastasis confirmed by endoscopy, CT, MRI, or PET\u002FCT scans, and multidisciplinary team (MDT) discussion.\n3. From a medical and surgical technical perspective, the primary lesion and surrounding abdominal lymph nodes are assessed as potentially resectable; limited metastatic lesions are evaluated by MDT for resectability or for the possibility of achieving curative treatment through other local treatment methods (such as local radiotherapy or radiofrequency ablation).\n4. Exclusion of peritoneal metastasis.\n5. Adequate hematological function: Neutrophil count ≥ 1.5 × 109\u002FL, Platelets ≥ 100 × 109\u002FL and Hemoglobin ≥90g\u002FL.\n6. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \\\u003C 2.5 × ULN in the absence of liver metastases, or \\\u003C 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g\u002FL.\n7. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml\u002Fmin.\n8. Adequate coagulation function: INR\u002FPT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN.\n9. No serious concomitant disease that will threaten the survival of patients to less than 5 years.\n10. Male or female. Age ≥ 18 years and ≤80 years.\n11. Written (signed) informed consent.\n12. Good compliance with the study procedures, including lab and auxiliary examination and treatment.\n13. Female patients should not be pregnant or breast feeding.\n\nExclusion Criteria:\n\n1. Non-adenocarcinoma histology of gastric\u002Fesophagogastric junction tumors, such as squamous cell carcinoma or neuroendocrine carcinoma.\n2. The primary lesion is considered unresectable from a medical or surgical technical perspective.\n3. Imaging diagnosis indicates widespread metastasis (metastasis that does not meet the criteria for limited metastasis as defined above is considered widespread metastasis).\n4. Peripheral neuropathy of grade ≥2.\n5. Poor nutritional status, BMI \\\u003C18.5 kg\u002Fm², or PG-SGA score ≥9.\n6. Underwent major surgery or suffered a severe injury within 4 weeks prior to the first dose of the investigational drug.\n7. Presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n8. Received any investigational drug within 4 weeks prior to the first dose of the study drug.\n9. Required systemic treatment with corticosteroids (daily \\>10 mg prednisone equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of the investigational drug.\n10. Received an anti-tumor vaccine or live vaccine within 4 weeks before the first dose of the study drug.\n11. Diagnosed with any active autoimmune disease or a history of autoimmune diseases.\n12. History of immunodeficiency, including a positive HIV test, any acquired or congenital immunodeficiency diseases, or a history of organ transplantation or allogeneic bone marrow transplantation.\n13. Any condition within 14 days prior to treatment requiring systemic corticosteroid therapy (dose\\>10mg\u002Fday of prednisone or equivalent) or other immunosuppressive treatments.\n14. Presence of uncontrolled cardiac symptoms or conditions, such as:\n\n    * NYHA Class II or higher heart failure\n    * Unstable angina\n    * Myocardial infarction within the past year\n    * Clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.\n15. Severe infection within 4 weeks prior to the first dose, including pneumonia requiring hospitalization, bacteremia, or infectious complications.\n16. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases.\n17. Active pulmonary tuberculosis infection diagnosed by history or CT scan, or a history of active tuberculosis infection within the past year, or a history of untreated active tuberculosis infection more than one year ago.\n18. Active hepatitis B or hepatitis C.\n19. Laboratory abnormalities of sodium, potassium, or calcium greater than Grade 1 within 2 weeks before enrollment that cannot be corrected with treatment.\n20. Known allergy to monoclonal antibodies, any PD-1 components, paclitaxel, capecitabine, or any components used in their formulations.\n21. Pregnant or breastfeeding women, or women of childbearing potential who are unwilling or unable to use effective contraception.",{"count":341,"type":20},30,[23],"Gastric cancer is one of the most common and deadly cancers globally, characterized by a poor prognosis. Approximately 70% of patients are diagnosed at an advanced stage, and the 5-year survival rate is only around 10%. While advancements in targeted therapies and immunotherapy have improved treatment efficacy and extended survival, advanced gastric and gastroesophageal junction adenocarcinomas remain incurable. Subgroup analyses indicate that patients with limited metastases, such as liver oligometastasis or retroperitoneal lymph node metastasis, may benefit more from conversion therapy. However, current guidelines do not recommend specific treatment protocols for gastric cancer with limited metastasis. Immunotherapy has shown moderate efficacy in selected patients with advanced gastric adenocarcinoma. Additionally, low-dose radiotherapy (LDRT) may synergistically enhance antitumor responses when combined with immunotherapy. This Phase II trial aims to evaluate the safety and efficacy of combining Adebrelimab, chemotherapy, and LDRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.",[345,346],"Gastroesophageal Adenocarcinoma","Gastric Adenocarcinoma","2025-05-15",{"date":349,"type":33},"2025-05-22",{"date":351,"type":20},"2025-05-16",{"date":353,"type":20},"2028-06-01",{"name":39,"class":40},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":4,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":362,"targetDuration":363,"studyType":221,"phases":4,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":371,"lastUpdatePostDateStruct":372,"startDateStruct":374,"completionDateStruct":376,"leadSponsor":378,"locationsCount":63},"100531366","mrd-guided-prognosis-prediction-and-adjuvant-treatment-based-on-ctc-and-ctdna-in-nsclc-100531366","NCT06198868","MRD-guided Prognosis Prediction and Adjuvant Treatment Based on CTC and ctDNA in NSCLC","Minimal Residual Disease (MRD) Guided Prognosis Prediction and Adjuvant Treatment Based on Expression and Mutational Signatures of Circulating Tumor Cell (CTC) and Circulating Tumor DNA (ctDNA) in Non-small Cell Lung Cancer","Inclusion Criteria:\n\n1. Written informed consent must be signed before implementing any enrollment-related procedures;\n2. Age ≥18 years old;\n3. Patients with histologically or cytologically confirmed stage IIA-IIIC NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer, 8th Edition TNM staging)；\n4. There is no special restriction on the source of genetic test report.\n5. According to the Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1), there is at least one radiographically measurable lesion.\n6. Have not received any previous systemic antitumor therapy for advanced diseases.\n7. No serious abnormalities of hematopoietic function, heart, lung, liver, kidney function and immune system.\n8. ECOG score: 0-1;\n9. Expected survival time \\> 3 months.\n\nExclusion Criteria:\n\n1. Received surgical treatment for lung tumors.\n2. Received neoadjuvant chemotherapy or radiotherapy.\n3. Received cellular therapy within the last 1 year.\n4. Treated but uncontrolled diabetes, mellitus, asthma, autoimmune diseases and other chronic diseases.\n5. Participated in other clinical trials (including research vaccines, drugs, medical devices, etc.) within one month.",{"count":220,"type":20},"5 Years","This is a prospective cohort study, which aims to evaluate the effectiveness and superiority of a novel minimal residual disease-guided prognosis monitoring and adjuvant treatment in stage IIA-IIIC non-small cell lung cancer.",[366],"Non-small Cell Lung Cancer",[176,368,369,370],"Minimal Residual Disease","Prognosis monitoring","Adjuvant treatment","2024-01-10",{"date":373,"type":33},"2024-01-12",{"date":375,"type":20},"2024-02-01",{"date":377,"type":20},"2027-02-01",{"name":39,"class":40},""]