[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"HuiKai Li\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100642405","phase-2-becotatug-vedotin-plus-pucotenlimab-for-advanced-biliary-tract-cancer-phase-ii-100642405",false,"NCT07649980","Becotatug Vedotin Plus Pucotenlimab for Advanced Biliary Tract Cancer, Phase II","Becotatug Vedotin Combined With Pucotenlimab in First-Line Treatment-Failed Advanced Biliary Tract Carcinoma: A Phase II Exploratory Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Histologically or cytologically confirmed advanced biliary tract cancer (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic cholangiocarcinoma (ECC), and gallbladder cancer (GBC); recurrent biliary tract cancer is also eligible.\n3. EGFR expression positive by immunohistochemistry (IHC) (+, ++, or +++).\n4. Failed at least one line of standard systemic therapy.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy ≥ 3 months.\n7. At least one measurable lesion per RECIST v1.1 on CT or MRI.\n8. Child-Pugh class A or B (\\\u003C7 points).\n9. Adequate organ function as defined below:\n\n   * Hematologic: Hemoglobin (Hb) ≥ 90 g\u002FL; white blood cell count (WBC) ≥ lower limit of normal (LLN); absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count ≥ 100 × 10⁹\u002FL.\n   * Renal: Serum creatinine ≤ 1.5 × upper limit of normal (ULN); creatinine clearance (CrCl) ≥ 55 mL\u002Fmin.\n   * Hepatic: Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN (or ≤ 3 × ULN for total bilirubin and ≤ 5 × ULN for ALT\u002FAST in patients with intrahepatic cholangiocarcinoma or liver metastases).\n   * Coagulation: International normalized ratio (INR) ≤ 1.5 × ULN; partial thromboplastin time (PTT) within normal range.\n10. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, or fever (\\>38°C) not attributable to cancer.\n11. Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the last dose. Male participants must agree to use effective contraception during the study and for 6 months after the last dose.\n12. Expected to have good compliance with protocol-specified follow-up for efficacy and safety assessments.\n13. Able to understand the study and willing to provide written informed consent.\n\nExclusion Criteria:\n\n1. Diagnosis of another primary malignancy within 5 years prior to enrollment, except for adequately treated carcinoma in situ or basal cell carcinoma of the skin.\n2. EGFR expression negative by IHC.\n3. Known central nervous system (CNS) metastases or carcinomatous meningitis, unless clinically stable for ≥ 4 weeks after radiotherapy or surgery and asymptomatic.\n4. Psychiatric or neurological disorders that compromise the ability to comply with study procedures.\n5. Prior treatment with MMAE-containing antibody-drug conjugate (ADC) therapy.\n6. Planned or previous organ or bone marrow transplantation.\n7. Active or history of autoimmune disease requiring systemic immunosuppressive therapy.\n8. Receipt of live vaccine within 30 days prior to first dose. Inactivated seasonal influenza vaccines are allowed.\n9. Uncontrolled cardiac conditions or symptoms.\n10. Active infection or fever (unless clearly attributable to tumor).\n11. History or evidence of interstitial lung disease or active non-infectious pneumonitis.\n12. Any other condition that makes the patient unsuitable for enrollment, including but not limited to: immunodeficiency; active tuberculosis; hepatitis B (eligible if HBV-DNA \\\u003C 500 IU\u002FmL with normal liver function after antiviral therapy); hepatitis C virus (HCV) infection; uncorrectable electrolyte disturbances; uncontrolled pericardial effusion, pleural effusion, or ascites.\n13. Known hypersensitivity to any component of the study drugs.\n14. Use of systemic immunosuppressive agents or corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) within 14 days prior to enrollment.\n15. Receipt of radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to enrollment.\n16. Participation in another interventional clinical trial within 4 weeks prior to enrollment.\n17. Pregnancy or breastfeeding.\n18. Any other condition that, in the investigator's judgment, makes the patient inappropriate for study participation.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Biliary tract carcinoma (BTC), including cholangiocarcinoma and gallbladder cancer, is a highly aggressive digestive system malignancy with limited treatment options after failure of first-line standard chemotherapy.\n\nThis open-label, single-arm, Phase II exploratory study aims to evaluate the efficacy and safety of Becotatug Vedotin combined with Pucotenlimab in patients with EGFR-positive advanced BTC who have failed first-line therapy. Participants will receive the combination regimen until the occurrence of disease progression, unacceptable toxicity, withdrawal of informed consent, death, pregnancy, investigator's decision to discontinue treatment, or study termination, whichever occurs first.The primary endpoint is objective response rate (ORR) assessed per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.",[26,27],"Biliary Tract Cancer (BTC)","EGFR-positive Advanced Biliary Tract Carcinoma",[29,30,31,32,33],"Becotatug Vedotin","Pucotenlimab","EGFR-ADC","PD-1","Second-line","NOT_YET_RECRUITING","2026-06-10",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":20},"2026-07-01",{"date":42,"type":20},"2029-12-31",{"name":44,"class":45},"HuiKai Li","OTHER",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100514205","phase-2-hepatic-artery-infusion-of-adebrelimab-combined-with-bevacizumab-in-the-treatment-of-advanced-hepatocellular-carcinoma-with-failure-of-systemic-therapy-combined-with-interventional-therapy-100514205","NCT05975463","Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy","Prospective Single Arm, Single Center, Phase II Clinical Study of Hepatic Artery Infusion of Adebrelimab Combined With Bevacizumab Treatment System for Advanced Hepatocellular Carcinoma With Failure of Systemic Therapy Combined With Interventional Therapy","Inclusion Criteria:\n\n* 1\\. Non resectable advanced hepatocellular carcinoma confirmed by pathological and clinical imaging examinations.\n* 2\\. Patients who have previously received systematic treatment combined with failed or intolerable interventional therapy.\n* 3\\. Male or female, aged ≥ 18 years at the time of signing the Informed consent form (ICF).\n* 4\\. The liver should have at least one measurable target lesion (RECIST v1.1). If it is an active lesion after local treatment (radiotherapy, ablation, transcatheter arterial chemoembolization, etc.), local treatment should be completed 4 weeks before the screening period imaging examination.\n* 5\\. The patient's Eastern Oncology Collaborative Group (ECOG) physical condition score is 0 or 1.\n* 6\\. The patient's organ and blood system functions meet the requirements:\n\n  1. Hematology function: Absolute neutrophil count (ANC) ≥ 1.5 x 10 \\^ 9\u002FL, platelet count ≥ 75 x 10 \\^ 9\u002FL\n  2. Adequate renal function: serum creatinine\\\u003C1.5x ULN or creatinine clearance rate\\>40 mL\u002Fmin (Cockcroft Fault formula)\n  3. Liver function: Total bilirubin ≤ 1.5 x ULN, Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 5 x ULN\n  4. Coagulation function: Within the normal range of Prothrombin time (PT) .\n* 7\\. Female participants with Fertility need to carry out serum pregnancy test within 72 hours before starting the study drug administration, and the result is negative, and take effective contraceptive measures (such as Intrauterine device, contraceptive pill or pregnancy avoidance condom) during the test period and at least 3 months after the last administration; For male participants whose partners are Fertility women, they should be surgically sterilized or agree to take effective contraceptive measures during the trial period and within 3 months after the last administration.\n* 8\\. The participants have good compliance and cooperate with follow-up.\n\nExclusion Criteria:\n\n* 1\\. Has a history of allergies to any component of the study drug in the past;\n* 2\\. Known to be allergic to Programmed Death-1\u002FProgrammed Death-L1 (PD-1\u002FPD-L1) antibodies or have experienced drug-related Immune related adverse events (irAEs) in the past, in accordance with the \"Guidelines Of Chinese Society Of Clinical Oncology \\[CSCO\\]Management Of Immune Checkpointinhibitor-Related Toxicity 2019\", it meets the indication for permanent discontinuation of medication;\n* 3\\. There are known Contraindication of percutaneous hepatic artery infusion;\n* 4\\. Has received or is currently receiving any of the following treatments in the past:\n\n  1. The patient underwent major surgical procedures within 14 days prior to entering the study (puncture biopsy is not included)\n  2. Previous or planned immune therapy such as Chimeric antigen receptor T cell immunotherapy (CAR-T) and vaccines\n* 5\\. Have any active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonia, enteritis, hepatitis, hypophysitis, Vasculitis, nephritis, hyperthyroidism, hypothyroidism (it can be considered to be included after hormone replacement treatment); Patients with psoriasis or childhood asthma\u002Fallergy that has completely alleviated and does not need any intervention after adulthood can be considered for inclusion, but patients who need medical intervention with Bronchiectasis cannot be included;\n* 6\\. Poor nutritional status, BMI\\\u003C18.5 Kg\u002Fm2; If symptomatic nutritional support is provided and corrected before enrollment, and evaluated by the main investigator, enrollment can continue to be considered;\n* 7\\. Have a history of immune deficiency, including positive Diagnosis of HIV\u002FAIDS, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;\n* 8\\. There are clinical symptoms or diseases of the heart that cannot be well controlled, including but not limited to: (1) New York Heart Association (NYHA)grade II or above heart failure, (2) unstable angina pectoris, (3) myocardial infarction within 1 year, (4) clinically significant supraventricular or ventricular arrhythmias that have not undergone clinical intervention or are still poorly controlled after clinical intervention;\n* 9\\. Serious infection (CTCAE\\>grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, Bloodstream infections, infection complications, etc. requiring hospitalization; Baseline chest imaging examination indicates the presence of active pulmonary inflammation, symptoms and signs of infection within 14 days prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment, excluding prophylactic use of antibiotics;\n* 10\\. Those who have been found to have active pulmonary tuberculosis infection through medical history or CT examination, or have a history of active pulmonary tuberculosis infection within 1 year before enrollment, or have a history of active pulmonary tuberculosis infection more than 1 year before but have not received formal treatment;\n* 11\\. There is active hepatitis B (HBV DNA ≥ 2000 IU\u002FmL or 104 copies\u002FmL) and hepatitis C (hepatitis C antibody is positive, and HCV RNA is higher than the detection limit of the analytical method);\n* 12\\. Other malignant tumors were diagnosed within 5 years before the first use of the study drug, except for malignant tumors with low risk of metastasis or death (5-year survival rate\\>90%), such as fully treated skin Basal-cell carcinoma or squamous cell skin cancer or cervical Carcinoma in situ, which can be considered to be included in the group;\n* 13\\. Pregnant or lactating women;\n* 14\\. Previous history of hypertensive crisis or hypertensive encephalopathy;\n* 15\\. Use Nonsteroidal anti-inflammatory drug (NSAIDs) for long-term daily treatment;\n* 16\\. Untreated or incompletely treated esophageal and\u002For gastric varices with high risk of bleeding or bleeding;\n* 17\\. Previous bleeding events caused by esophageal and\u002For gastric varices within 6 months prior to the start of the study treatment;\n* 18\\. According to the judgment of the investigators, there are other factors that may lead to forced termination of the study, such as suffering from other serious illnesses (including mental illness) requiring concurrent treatment, alcoholism, drug abuse, family or social factors, which may affect the safety or compliance of the participants.",{"count":19,"type":20},[23],"The goal of this prospective single arm, Phase II Clinical Study is to explore and evaluate the efficacy and safety of hepatic artery infusion of Adebrelimab combined with Bevacizumab in the treatment of patients with advanced hepatocellular carcinoma who failed in systematic therapy combined with interventional therapy.\n\nParticipants will receive hepatic artery infusion of Adebrelimab 1200mg, d1, q3w, combined with hepatic artery infusion of Bevacizumab 5mg\u002Fkg, d1, q3w, HAIC treatment for 3-4 times.",[57],"Hepatocellular Carcinoma","2023-08-31",{"date":60,"type":38},"2023-09-01",{"date":62,"type":20},"2023-09-15",{"date":64,"type":20},"2026-07-31",{"name":44,"class":45},1,""]