[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Eastern Hepatobiliary Surgery Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":318},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,45,74,99,125,148,167,190,217,242,269,291],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100642862","phase-2-efficacy-and-safety-of-sbrt-plus-gemcitabine-cisplatin-and-sintilimab-as-first-line-treatment-for-unresectable-biliary-tract-cancer-100642862",false,"NCT07638501","Efficacy and Safety of SBRT Plus Gemcitabine, Cisplatin, and Sintilimab as First-Line Treatment for Unresectable Biliary Tract Cancer","Evaluation of the Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) Combined With Gemcitabine, Cisplatin, and Sintilimab as First-Line Therapy for Unresectable Biliary Tract Cancer: A Prospective, Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Patients voluntarily provide written informed consent, with authorization obtained from the patient or legal representative prior to any protocol-related procedures.\n2. Age ≥ 18 years and ≤ 75 years; both female and male\n3. Histologically or cytologically confirmed, unresectable advanced or metastatic adenocarcinoma of biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.\n4. No prior systemic anti-tumor treatment for BTC. Patients who developed recurrent disease \\>6 months after surgery with curative intent and, if given, \\>6 months after the completion of neo\u002Fadjuvant therapy (chemotherapy and\u002For radiation) will be eligible.\n5. At least 1 lesion that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline.\n6. ECOG performance status of 0 or 1.\n7. Life expectancy ≥12 weeks.\n8. Adequate organ and bone marrow function within 14 days prior to initiation of study treatment, defined as follows:\n\n   a.Hematology (without transfusion, granulocyte colony-stimulating factor \\[G-CSF\\], or other correction treatment within 14 days prior to screening): i.Hemoglobin \\[HB\\] ≥ 90 g\u002FL; ii.Absolute neutrophil count \\[ANC\\] ≥ 1.5 × 109\u002FL; iii.platelet count (PLT) ≥ 75 × 109\u002FL b.Biochemistry Examination (without albumin infusion within 14 days prior to screening): i.Total bilirubin (TBIL) ≤ 2 × upper limit of normal (ULN) (for patients with Gilbert's syndrome, ≤ 3 × ULN) ii.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN; iii.serum creatinine (Cr) ≤ 1.5 × ULN or clearance of creatinine (CCr) ≥ 50 mL\u002Fmin (Cockcroft-Gault formula);\n   * Male: Creatinine clearance rate = \\[(140 - age) × weight\\] \u002F (72 × serum Cr)\n   * Female: Creatinine clearance rate= \\[(140 - age) × weight\\] \u002F (72 × serum Cr) × 0.85 (Weight unit: kg; serum Cr unit: mg\u002FdL)\n9. Patients with evidence of hepatitis B virus (HBV) infection, defined as detectable HBV DNA (≥10 IU\u002FmL or above the lower limit of detection according to local laboratory standards) and positive HBsAg and\u002For anti-HBc, must receive antiviral therapy prior to study drug administration in accordance with institutional practice to ensure adequate viral suppression. Antiviral therapy must be continued throughout the study period and for at least 6 months after the last dose of study treatment. Patients who are anti-HBc positive but HBV DNA negative (\\\u003C10 IU\u002FmL or below the lower limit of detection according to local laboratory standards) are not required to receive antiviral therapy unless HBV DNA rises to ≥10 IU\u002FmL or exceeds the local lower limit of detection during study treatment.\n10. Female patients of childbearing age must have a documented negative urine or serum pregnancy test within 7 days prior to the first dose. If the urine test result is inconclusive, a serum test must be performed, and the serum result will be considered definitive. Female patients of childbearing age who have sexual intercourse with non-sterilized male partners must agree to take effective contraceptive measures throughout the treatment and 120 days after the last dose.\n11. Male patients with female sexual partners of childbearing age must agree to take effective contraceptive measures throughout the treatment and 120 days after the last dose. The decision to discontinue contraception beyond this time frame should be discussed with the investigator.\n12. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed rare biliary tract tumors, including ampullary cancer, neuroendocrine tumors, sarcoma, or mucinous cystic neoplasms.\n2. Other active malignancy within the past 5 years or concurrent, except adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.\n3. History of carcinomatous meningitis or brain metastases.\n4. Known hypersensitivity or allergic reaction to any study drug or any excipient therein.\n5. Participation in another investigational drug clinical trial within the past 3 months or concurrent enrollment in another clinical study, unless observational, non-interventional, or follow-up phase of an interventional study.\n6. Uncontrolled concurrent illness, including but not limited to moderate to severe ascites, uncontrolled or moderate-to-large pleural or pericardial effusion, uncontrolled acute or chronic pancreatitis, active hemorrhagic disorder, or severe chronic gastrointestinal disease associated with diarrhea.\n7. History of allogeneic organ or allogeneic bone marrow transplantation.\n8. History of significant cardiovascular or cerebrovascular disease, including:\n\n   1. congestive heart failure (NYHA Class ≥II), unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months prior to first dose;\n   2. left ventricular ejection fraction \\\u003C50%;\n   3. corrected QT interval (QTc) \\>480 ms (Fridericia formula);\n   4. poorly controlled hypertension (systolic ≥150 mmHg or diastolic ≥100 mmHg based on ≥2 measurements);\n   5. history of hypertensive crisis or hypertensive encephalopathy.\n9. Active autoimmune disease within 2 years prior to first dose or history of autoimmune disease with potential for relapse, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (except hypothyroidism controlled by hormone replacement therapy).\n10. Prior anti-cancer therapy-related adverse events not recovered to Grade ≤1 or baseline, with Grade ≤2 neuropathy possibly eligible per investigator assessment.\n11. Active infection, including tuberculosis or human immunodeficiency virus (HIV).\n12. Diagnosis of immunodeficiency, or chronic systemic steroid therapy (daily dose \\>10 mg prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of study intervention.\n13. History of gastrointestinal bleeding within 6 months prior to study treatment, documented predisposition to gastrointestinal hemorrhage, or known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency.\n14. Major surgery (excluding biopsy) with incomplete recovery from surgery or surgical complications, or incomplete wound healing, prior to start of study intervention, or anticipated need for major surgery during the study period.\n15. Receipt of live attenuated vaccine within 28 days prior to first dose of study intervention, or anticipated need for live attenuated vaccine during study treatment or within 60 days after last dose.\n16. Any other condition judged by the investigator to potentially interfere with study outcomes or lead to premature study termination, including alcohol or drug abuse, severe comorbidity requiring concomitant therapy (including psychiatric illness), severe laboratory abnormality, or family or social factors affecting patient safety or data collection.","ALL","18 Years","75 Years",{"count":20,"type":21},123,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","According to current clinical guidelines, first-line treatment for advanced biliary tract cancer (BTC) is the gemcitabine plus cisplatin (GC) regimen combined with immunotherapy, which has been shown to improve patient outcomes. Additionally, the combination of radiotherapy and immunotherapy may synergistically enhance antitumor efficacy. Therefore, this study aims to assess the efficacy and safety of first-line treatment with radiotherapy in combination with sintilimab and gemcitabine\u002Fcisplatin versus sintilimab in combination with gemcitabine\u002Fcisplatin in patients with previously untreated, unresectable locally advanced or metastatic BTC.",[27],"Biliary Tract Cancer (BTC)",[29,30,31],"First-line Therapy","Stereotactic Body Radiotherapy (SBRT)","Immunotherapy","NOT_YET_RECRUITING","2026-06-04",{"date":35,"type":36},"2026-06-10","ACTUAL",{"date":38,"type":21},"2026-06-15",{"date":40,"type":21},"2029-06-15",{"name":42,"class":43},"Eastern Hepatobiliary Surgery Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":4},"100638856","phase-2-effects-of-short-term-perioperative-daidzein-intervention-on-liver-histopathology-in-patients-with-masld-100638856","NCT07623044","Effects of Short-term Perioperative Daidzein Intervention on Liver Histopathology in Patients With MASLD","Short-Term Daidzein Intervention in MASLD","DAIMAS","Inclusion Criteria:\n\n* Adults aged 18 to 70 years.\n* Male or female participants.\n* Scheduled to undergo elective laparoscopic cholecystectomy or other benign biliary surgery for benign biliary disease.\n* Diagnosis of metabolic dysfunction-associated steatotic liver disease based on hepatic steatosis shown by liver biopsy or imaging, including controlled attenuation parameter, ultrasound, or magnetic resonance imaging, together with at least one cardiometabolic risk factor.\n* Expected preoperative window of at least 28 days before surgery.\n* Able and willing to provide written informed consent.\n* Willing to provide blood samples, urine samples, and intraoperative liver tissue samples.\n* Able and willing to avoid soy-containing foods during the study period, including soybeans, edamame, black soybeans, soy milk, tofu, dried tofu, tofu skin, yuba, tofu pudding, natto, miso, fermented soybeans, tempeh, and other traditional or fermented soy products.\n\nExclusion Criteria:\n\n* Viral hepatitis, autoimmune liver disease, drug-induced liver injury, Wilson disease, or other clearly defined chronic liver diseases.\n* Significant alcohol consumption, defined as more than 140 g per week for women or more than 210 g per week for men.\n* Liver cirrhosis, decompensated liver disease, or hepatobiliary malignancy.\n* Use of antibiotics, probiotics, soy isoflavone-containing products, or hormone-like dietary supplements within 4 weeks before enrollment.\n* Treatment within 3 months before enrollment that may substantially affect body weight or the severity of fatty liver disease.\n* Known allergy to soy products, daidzein, or isoflavones.\n* Pregnancy or breastfeeding.\n* Any condition that, in the opinion of the investigator, makes the participant unsuitable for this study.","70 Years",{"count":55,"type":21},44,[24],"This clinical trial aims to learn whether daidzein can improve liver tissue changes in adults with metabolic dysfunction-associated steatotic liver disease, also called MASLD. MASLD is a liver condition linked to extra fat in the liver and metabolic problems such as obesity, diabetes, abnormal blood lipids, or high blood pressure.\n\nDaidzein is a natural compound found in soy. Earlier laboratory studies suggest that daidzein may help protect the liver. This study will test whether taking daidzein for a short time before surgery can improve liver tissue findings in people with MASLD.\n\nThe main questions this study aims to answer are:\n\nDoes short-term daidzein treatment improve liver tissue injury in people with MASLD? Is daidzein safe and well tolerated before surgery? Are changes in blood or urine equol levels related to the effects of daidzein? Equol is a substance made by gut bacteria after some people take daidzein.\n\nResearchers will compare people who take daidzein before surgery with people who receive standard care without daidzein.\n\nParticipants will:\n\nBe adults with MASLD who are scheduled for elective gallbladder surgery or another benign biliary surgery.\n\nBe randomly assigned to take daidzein or to receive standard care without daidzein.\n\nTake daidzein by mouth for 28 days before surgery if assigned to the daidzein group.\n\nAvoid soy foods during the study period. Provide blood and urine samples. Have a small liver tissue sample collected during surgery. Be followed for safety and recovery after surgery.\n\nThe liver tissue sample will be used to check liver fat, inflammation, and liver cell injury. Researchers will also study markers related to liver injury, immune activity, and how the body responds to daidzein.",[59],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[61,62,63,64,65],"Metabolic dysfunction-associated steatotic liver disease","Daidzein","Ferroptosis","Randomized controlled trial","Soy isoflavone","2026-06-01",{"date":68,"type":36},"2026-06-03",{"date":70,"type":21},"2026-05-21",{"date":72,"type":21},"2026-08-10",{"name":42,"class":43},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":44},"100620879","phase-2-drug-sensitivity-testing-based-tumor-organoids-to-guide-adjuvant-therapy-after-hepatectomy-for-primary-liver-cancer-100620879","NCT07363356","Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer","Drug Sensitivity Testing-Based Tumor Organoids to Guide Adjuvant Therapy After Hepatectomy for Primary Liver Cancer: A Prospective, Non-Randomized，Open-Label, Phase II Clinical Trial","Inclusion Criteria:\n\n1. Male or female, aged 18 to 70 years.\n2. Diagnosed with primary liver cancer according to the diagnostic criteria of the primary liver cancer (e.g., Guidelines for Diagnosis and Treatment of Primary Liver Cancer), with post-operative pathological confirmation of hepatocellular carcinoma (HCC). Patients must have at least one of the following high-risk pathological features: tumor diameter \\>5 cm, more than 3 tumors, presence of microvascular invasion, presence of minor macrovascular invasion, or poor pathological differentiation (Grade 3\u002F4).\n3. The subject or their legal guardian understands and voluntarily signs the informed consent form, and is willing and able to complete the scheduled visits, treatment plan, and laboratory tests as required by the protocol.\n4. Life expectancy of more than 6 months.\n5. No radiotherapy within 12 weeks prior to the first dose of study drug.\n6. Liver function classified as Child-Pugh Class A or Class B with a score of 7.\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n8. Adequate organ and bone marrow function, defined as laboratory values meeting the following criteria within 7 days prior to randomization (without the support of blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to obtaining the laboratory tests):\n\n   8.1. Hematological:\n\n   8.1. 2. Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹\u002FL\n\n   8.1. 3. Platelet count (PLT) ≥75 × 10⁹\u002FL\n\n   8.1. 4. Hemoglobin (HGB) ≥9.0 g\u002FdL\n\n   8.2. Hepatic:\n\n   8.2.1. Total Bilirubin (TBIL) ≤3 × Upper Limit of Normal (ULN)\n\n   8.2.2. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤5 × ULN\n\n   8.2.3. Serum Albumin ≥28 g\u002FL\n\n   8.3. Renal:\n\n   8.3.1. Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n\n   8.3.2. Urinalysis shows urine protein \\\u003C 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification \\\u003C1 g.\n\n   8.4. Coagulation:\n\n   8.4.1. International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n9. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to receiving the first dose of study drug (Cycle 1, Day 1). If the urine pregnancy test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of \\\u003C1% per year) during the entire treatment period and for 120 days after the last dose of study drug (or 180 days after the last dose of chemotherapy agents).\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy or significant bleeding tendency.\n2. Evidence of any concurrent malignant disease.\n3. Diagnosed with another malignancy within 3 years prior to the first dose, except for radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone curative resection.\n4. Requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.\n5. Presence of hepatic encephalopathy or refractory pleural effusion\u002Fascites requiring therapeutic intervention.\n6. Received other anti-tumor or systemic therapies within 2 weeks prior to enrollment, including:\n\n   6.1. Chinese herbal medicines with clear anti-tumor properties.\n\n   6.2. Chinese herbal medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion).\n7. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:\n\n   7.1. autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement) is not considered a form of systemic treatment.\n\n   7.2. Systemic corticosteroid therapy (excluding topical, nasal, inhaled, or other non-systemic routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n8. Severe hepatic or renal insufficiency.\n9. Presence of any severe or uncontrolled systemic disease, including but not limited to:\n\n   9.1. Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmias, or atrial fibrillation).\n\n   9.2. Unstable angina, congestive heart failure (New York Heart Association (NYHA) Class ≥ II).\n\n   9.3. Myocardial infarction within 6 months prior to randomization.\n\n   9.4. History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.\n\n   9.5. Poorly controlled hypertension (systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n\n   9.6. History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n\n   9.7. Active tuberculosis.\n\n   9.8. Active or uncontrolled infection requiring systemic therapy.\n\n   9.9. Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n\n   9.10. Decompensated liver disease, acute or chronic active hepatitis.\n\n   9.11. Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.\n\n   9.12. Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL).\n\n   9.13. Urinalysis showing urine protein ≥ ++ and confirmed 24-hour urine protein \\>1.0 g.\n\n   9.14. Uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.\n\n   9.15. Non-healing wound(s) or fracture(s).\n\n   9.16. Psychiatric disorder that compromises the ability to comply with the treatment protocol.\n10. Female subjects who are breastfeeding or pregnant.\n11. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.\n12. Known allergy to any of the study drug(s) used in this trial.",{"count":82,"type":21},56,[24],"This is a single-center, prospective, non-randomized, open-label, phase II clinical trial aiming to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized adjuvant therapy in patients with primary liver cancer (HCC) following curative liver resection. A total of 56 eligible patients will be enrolled. Tumor tissues obtained during surgery will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved targeted and immunotherapeutic agents (including Apatinib, Atezolizumab + Bevacizumab, Donafenib + Toripalimab, Sintilimab, and FOLFOX) to identify the most effective treatment for each patient. Patients for whom organoid testing fails or results are unavailable within the specified timeframe will receive standard Lenvatinib treatment. The primary endpoint is Recurrence-Free Survival (RFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel strategy for personalized adjuvant therapy in HCC to improve patient outcomes.",[86],"Hepatocellular Carcinoma Resectable",[88,89,90],"organoid;","drug-sensitive test;","adjuvant therapy","2026-01-22",{"date":93,"type":36},"2026-01-23",{"date":95,"type":21},"2026-01-30",{"date":97,"type":21},"2028-11-30",{"name":42,"class":43},{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":44},"100620952","phase-2-haic-combined-with-immune-therapy-for-advanced-non-resectable-icc-100620952","NCT07364305","HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC","HAIC Combined With Immune Therapy for Advanced, Non-Resectable ICC: A Single-Arm, Multicenter Phase II Clinical Trial","Lalo","Inclusion Criteria:\n\n1. Age: Age ≥ 18 years old.\n2. Diagnosis: Advanced unresectable intrahepatic cholangiocarcinoma (ICC) diagnosed by histology or imaging.\n3. Measurable lesion: At least one measurable tumor lesion (according to RECIST 1.1 criteria).\n4. Physical fitness status: The Eastern Cancer Collaboration Group (ECOG) physical fitness status score is 0 or 1.\n5. Expected lifespan: Expected lifespan ≥ 3 months.\n6. Liver function: Child Pugh classification A or B.\n7. Organ function: It has sufficient organ function and laboratory tests meet the requirements of the protocol.\n8. Not receiving relevant treatment: Not receiving systematic treatment for ICC.\n\nExclusion Criteria:\n\n1. Previous treatment: Previously received systemic treatment for ICC.\n2. Poor physical condition: ECOG physical condition score ≥ 2.\n3. Poor liver function: Child Pugh grading\\>8.\n4. Short life expectancy: Life expectancy is less than 3 months.\n5. Merge with other malignant tumors: have other malignant tumors or a history of other malignant tumors.\n6. Serious organ dysfunction: There is severe dysfunction in organs such as the heart, brain, lungs, and kidneys.\n7. Drug allergy or intolerance: Allergic to the investigational drug or its excipients.\n8. Other: Other situations that the researcher deems unsuitable to participate in this study",true,{"count":109,"type":21},50,[24],"Intrahepatic cholangiocarcinoma (ICC) has a poor prognosis. The aim of this study is to investigate the efficacy and safety of GP-HAIC combined with immunosuppressants in the treatment of initially unresectable ICC patients, as well as its role in conversion therapy. A prospective study was conducted on the data of locally advanced unresectable ICC patients receiving GC-HAIC combined with immunosuppressive therapy, evaluating the treatment efficacy and safety.",[113,114],"ICC","Advanced Cancer",[116,31],"HAIC","RECRUITING","2026-01-15",{"date":93,"type":36},{"date":121,"type":36},"2025-01-01",{"date":123,"type":21},"2028-01-01",{"name":42,"class":43},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":132,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100619968","phase-2-a-phase-ii-trial-of-organoid-drug-sensitivity-testing-to-guide-therapy-in-unresectable-hepatocellular-carcinoma-100619968","NCT07351513","A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Hepatocellular Carcinoma","Patient-Derived Tumor Organoid Drug Sensitivity Testing to Guide Treatment Selection in Patients With Unresectable Hepatocellular Carcinoma: A Prospective, Non-randomized, Open-label, Single-Center Phase II Clinical Trial","Inclusion Criteria:\n\n1. Male or female, aged between 18 and 70 years (inclusive).\n2. Diagnosis of primary liver cancer confirmed according to the diagnostic criteria of the Chinese Guidelines for Diagnosis and Treatment of Primary Liver Cancer.\n3. The subject or their legal guardian understands and voluntarily signs the Informed Consent Form, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as required by the protocol.\n4. Life expectancy of at least 6 months.\n5. No radiotherapy within 12 weeks prior to the first dose of the study drug.\n6. Liver function classified as Child-Pugh Class A or Class B with a score of 7.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n8. Adequate organ and bone marrow function, defined by the following laboratory values within 7 days prior to randomization (without receiving any blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to the laboratory tests):\n\n   8.1. Hematological:\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n   * Platelet count (PLT) ≥ 75 × 10⁹\u002FL\n   * Hemoglobin (HGB) ≥ 9.0 g\u002FdL 8.2. Hepatic:\n   * Total Bilirubin (TBIL) ≤ 3 × Upper Limit of Normal (ULN)\n   * Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤ 5 × ULN\n   * Serum Albumin ≥ 28 g\u002FL 8.3. Renal:\n   * Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Urinalysis indicates urine protein \\\u003C 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification \\\u003C 1 g.\n\n   8.4. Coagulation:\n\n   \\* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n9. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If a urine test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of \\\u003C1% per year) during the entire treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy agents).\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy or individuals with a significant bleeding tendency.\n2. Evidence of any concurrent malignant disease.\n3. Diagnosis of another malignancy within 3 years prior to the first dose, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ that has undergone curative resection.\n4. Patients requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.\n5. Presence of hepatic encephalopathy or refractory pleural effusion\u002Fascites requiring therapeutic intervention.\n6. Receipt of other anti-tumor or systemic therapies within 2 weeks prior to enrollment, including:\n\n   * Chinese herbal medicine with demonstrated anti-tumor properties.\n   * Chinese herbal medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin), except for localized use to control pleural effusion.\n7. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:\n\n   * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n   * Systemic corticosteroid therapy (excluding topical, intranasal, inhaled, or other local routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n8. Severe hepatic or renal insufficiency.\n9. Presence of any severe or uncontrolled systemic disease, including but not limited to:\n\n   * Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation).\n   * Unstable angina, congestive heart failure (New York Heart Association Class ≥ II).\n   * Myocardial infarction within 6 months prior to randomization.\n   * History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.\n   * Poorly controlled hypertension (systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n   * History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n   * Active tuberculosis.\n   * Active or uncontrolled infection requiring systemic therapy.\n   * Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n   * Decompensated liver disease, acute or chronic active hepatitis.\n   * Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.\n   * Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL).\n   * Urinalysis indicating urine protein ≥ ++ and confirmed 24-hour urine protein quantification \\>1.0 g.\n   * Uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.\n   * Non-healing wound(s) or fracture(s).\n   * Psychiatric disorder that compromises the ability to comply with the treatment protocol.\n10. Female subjects who are pregnant or breastfeeding.\n11. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.\n12. Known allergy to any of the study drug(s) used in this trial.",{"count":133,"type":21},94,[24],"This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (DST) to guide personalized systemic therapy for patients with unresectable hepatocellular carcinoma (HCC). A total of 94 eligible patients will be enrolled and grouped based on patient preference into either the Organoid-Directed Therapy group or the Control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a pre-defined panel of approved regimens (including Atezolizumab + Bevacizumab, Sintilimab + Bevacizumab biosimilar, Apatinib + Camrelizumab, Donafenib, Lenvatinib, Tislelizumab, Sorafenib, and FOLFOX4) to identify the most effective treatment. Patients for whom organoid construction fails or valid DST results are unavailable within one month will cross over to the control group to receive standard therapy. The co-primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS), both assessed according to RECIST 1.1. Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced, unresectable HCC.",[137],"Unresectable Hepatocellular Carcinoma",[139,140],"organoid","drug-sensitive test","2026-01-10",{"date":143,"type":36},"2026-01-20",{"date":95,"type":21},{"date":146,"type":21},"2028-12-31",{"name":42,"class":43},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":155,"targetDuration":4,"studyType":22,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100619974","phase-2-a-phase-ii-trial-of-organoid-drug-sensitivity-testing-to-guide-therapy-in-unresectable-biliary-tract-cancers-100619974","NCT07351591","A Phase II Trial of Organoid Drug Sensitivity Testing to Guide Therapy in Unresectable Biliary Tract Cancers","Patient-Derived Tumor Organoid Drug Sensitivity Testing to Guide Treatment Selection in Patients With Unresectable Biliary Tract Cancers: A Prospective, Non-randomized, Open-label, Single-Center Phase II Clinical Trial","Inclusion Criteria:\n\n1. Male or female, aged between 18 and 70 years (inclusive).\n2. Diagnosis of biliary tract malignancy confirmed according to the NCCN Clinical Practice Guidelines.\n3. The subject or their legal guardian understands and voluntarily signs the Informed Consent Form, and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures as required by the protocol.\n4. The subject is not a candidate for curative resection, transplantation, or local ablation therapy. This includes patients with recurrent disease after prior radical therapy who are not eligible for further curative resection or ablation.\n5. Life expectancy of at least 12 weeks.\n6. No radiotherapy within 12 weeks prior to the first dose of the study drug.\n7. Liver function classified as Child-Pugh Class A or Class B with a score of 7.\n8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n9. Adequate organ and bone marrow function, defined by the following laboratory values within 7 days prior to randomization (without receiving any blood transfusions, hematopoietic growth factors, albumin, or other corrective drugs within 14 days prior to the laboratory tests):\n\n   9.1. Hematological:\n   * Absolute Neutrophil Count (ANC) ≥ 1.5 × 10⁹\u002FL\n   * Platelet count (PLT) ≥ 75 × 10⁹\u002FL\n   * Hemoglobin (HGB) ≥ 9.0 g\u002FdL 9.2. Hepatic:\n   * Total Bilirubin (TBIL) ≤ 3 × Upper Limit of Normal (ULN)\n   * Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Alkaline Phosphatase (ALP) ≤ 5 × ULN\n   * Serum Albumin ≥ 28 g\u002FL 9.3. Renal:\n   * Serum Creatinine (Cr) ≤ 1.5 × ULN or Creatinine Clearance (CCr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   * Urinalysis indicates urine protein \\\u003C 2+; if baseline urinalysis shows urine protein ≥ 2+, a 24-hour urine collection must demonstrate 24-hour urine protein quantification \\\u003C 1 g.\n\n   9.4. Coagulation:\n\n   \\* International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n10. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to the first dose of study drug (Cycle 1, Day 1). If a urine test is inconclusive, a serum pregnancy test is required. WOCBP and male subjects must agree to use adequate contraception during the observation period and for at least 8 weeks after the last dose of the study drug. A woman is considered not of childbearing potential if she is postmenopausal (≥1 year without menses) or has undergone surgical sterilization (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation). Subjects (both male and female) with risk of pregnancy must use highly effective contraception (with a failure rate of \\\u003C1% per year) during the entire treatment period and for 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy agents).\n\nExclusion Criteria:\n\n1. Uncorrectable coagulopathy or individuals with a significant bleeding tendency.\n2. Evidence of any concurrent malignant disease.\n3. Diagnosis of another malignancy within 3 years prior to the first dose, except for radically treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and\u002For carcinoma in situ that has undergone curative resection.\n4. Patients requiring long-term anticoagulant or antiplatelet therapy that cannot be discontinued.\n5. Presence of hepatic encephalopathy or refractory pleural effusion\u002Fascites requiring therapeutic intervention.\n6. Other anti-tumor or systemic therapies within 2 weeks prior to enrollment:\n\n   * Treatment with Chinese herbal medicine with demonstrated anti-tumor properties.\n   * Treatment with Chinese herbal medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin), except for localized use to control pleural effusion.\n7. History of systemic treatment for active autoimmune disease or ongoing immunosuppressive therapy:\n\n   * Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n   * Systemic corticosteroid therapy (excluding topical, intranasal, inhaled, or other local routes) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. The use of physiologic doses of corticosteroids (≤10 mg\u002Fday prednisone or equivalent) is permitted.\n8. Severe hepatic or renal insufficiency.\n9. Presence of any severe or uncontrolled systemic disease, including but not limited to:\n\n   * Clinically significant, poorly controlled resting ECG abnormalities (e.g., complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation).\n   * Unstable angina, congestive heart failure (New York Heart Association (NYHA) Class ≥ II).\n   * Myocardial infarction within 6 months prior to randomization.\n   * History of esophageal or gastric variceal bleeding within 6 months prior to enrollment.\n   * Poorly controlled hypertension (systolic blood pressure \\>140 mmHg and\u002For diastolic blood pressure \\>90 mmHg).\n   * History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n   * Active tuberculosis.\n   * Active or uncontrolled infection requiring systemic therapy.\n   * Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n   * Decompensated liver disease, acute or chronic active hepatitis.\n   * Unstable or active peptic ulcer disease, or patients with gastrointestinal bleeding.\n   * Poorly controlled diabetes mellitus (fasting blood glucose \\>10 mmol\u002FL).\n   * Urinalysis indicating urine protein ≥ ++ and confirmed 24-hour urine protein quantification \\>1.0 g.\n   * Uncontrolled hypercalcemia (\\>1.5 mmol\u002FL ionized calcium, or calcium \\>12 mg\u002FdL, or corrected serum calcium \\> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate therapy.\n   * Non-healing wound(s) or fracture(s).\n   * Psychiatric disorder that compromises the ability to comply with the treatment protocol.\n10. Female subjects who are pregnant or breastfeeding.\n11. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.\n12. Known allergy to any of the study drug(s) used in this trial.",{"count":156,"type":21},88,[24],"This is a prospective, non-randomized, open-label, single-center phase II clinical trial. It aims to evaluate the efficacy and feasibility of using patient-derived tumor organoid drug sensitivity testing (ODST) to guide personalized systemic therapy for patients with unresectable biliary tract cancers (BTC). A total of 88 eligible patients will be enrolled and grouped based on patient preference into either the ODST-guided group or the control group (standard therapy). Tumor tissues obtained via biopsy will be used to establish organoid cultures. Drug sensitivity testing will be performed on a panel of approved regimens (including GC, GEMOX, Durvalumab+GC, Pembrolizumab+GC, and Toripalimab+Lenvatinib+GEMOX) to identify the most effective treatment. Patients for whom organoid testing fails or results are unavailable within one month will receive standard therapy. The primary endpoints are Objective Response Rate (ORR) and Progression-Free Survival (PFS). Secondary endpoints include Overall Survival (OS) and safety profiles. The study seeks to provide a novel, personalized treatment strategy to improve outcomes for patients with advanced BTC.",[160],"Advanced Biliary Tract Cancer(BTC)",[139,140],{"date":143,"type":36},{"date":95,"type":21},{"date":165,"type":21},"2027-12-31",{"name":42,"class":43},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":44},"100618854","a-trial-of-behavioral-intervention-on-prognostic-survival-of-patients-with-unresectable-liver-cancer-100618854","NCT07337031","A Trial of Behavioral Intervention on Prognostic Survival of Patients With Unresectable Liver Cancer","A Randomized Controlled Trial of Complex Behavioral Intervention on Prognostic Survival in Comprehensive Treatment of Patients With Unresectable Liver Cancer","Inclusion Criteria:\n\n1. Pathologically or radiologically confirmed primary hepatocellular carcinoma;\n2. BCLC stage B-C, initially assessed as unresectable;\n3. Age 18-75 years;\n4. ECOG performance status score 0-2;\n5. Child-Pugh classification grade A or B (\\\u003C=9 points);\n6. Normal cognitive ability, capable of understanding and following intervention protocols;\n7. Both the patient and primary caregiver can use a smartphone and the WeChat platform and are able to complete questionnaires and follow-up tasks;\n8. Voluntarily participates in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n1. Presence of malignant tumors in other organs;\n2. Presence of extrahepatic metastasis;\n3. Presence of any of the following severe organic diseases in any organ:\n\n(1) Cardiovascular: NYHA class III-IV heart failure, acute coronary syndrome within the past 6 months; (2) Liver: Child-Pugh class C cirrhosis, or ALT\u002FAST \\>5 times the upper limit of normal; (3) Kidney: eGFR \\\u003C45 mL\u002Fmin\u002F1.73m\\^2 or dialysis-dependent; (4) Respiratory: respiratory failure requiring long-term oxygen therapy; (5) Hematologic: hemoglobin \\\u003C9 g\u002FdL or platelets \\\u003C75×10\\^9\u002FL; 4. History of psychiatric disorders, severe cognitive impairment, or substance abuse; 5. Previous liver transplantation or treatment for malignant liver tumors; 6. Complete thrombosis of the main portal vein; 7. Female patients who are pregnant or breastfeeding; 8. Presence of severe congenital or acquired immunodeficiency; 9. Unwillingness to sign the informed consent form; 10. Other conditions deemed unsuitable for participation in this study by the investigator.",{"count":175,"type":21},193,[177],"NA","Research purpose\n\n1. To evaluate the impact of complex behavioral intervention on the one-year overall survival rate of patients with unresectable liver cancer after comprehensive treatment, a comparative study was conducted between the complex behavioral intervention group and the standard medical care control group, and the dose-response relationship between the intervention intensity and clinical outcomes was explored.\n2. Analyze the impact mechanisms of complex behavioral interventions on patients' quality of life, adverse treatment reactions, and key biological indicators, including evaluating clinical outcomes such as 2-year overall survival rate, progression-free survival (PFS), objective response rate (ORR), and disease control rate (DCR), as well as the association between changes in related biomarkers and behavioral compliance.\n3. Evaluate the implementation effect and sustainability of the \"in-hospital face-to-face + wechat platform\" hybrid intervention model, including intervention acceptance, long-term behavior maintenance, health economic benefits, and perioperative recovery of patients undergoing down-conversion surgery.",[180,181],"Primary Hepatocellular Carcinoma","Unresectable Liver Cancer","2026-01-04",{"date":184,"type":36},"2026-01-13",{"date":186,"type":21},"2026-01",{"date":188,"type":21},"2028-12",{"name":42,"class":43},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":107,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":202,"conditions":203,"keywords":205,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":44},"100614919","phase-2-the-efficacy-of-sequential-treatment-with-bevacizumab-combined-with-atezolizumab-in-advanced-liver-cancer-with-masld-100614919","NCT07285850","The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD","The Efficacy of Sequential Treatment With Bevacizumab Combined With Atezolizumab in Advanced Liver Cancer With MASLD Background: a Dual Arm, Multicenter, Randomized Controlled Study","ABATE-MASLD","Eligibility Criteria Inclusion Criteria\n\n* Age ≥ 18 years old (gender not limited)\n* ECOG performance status of 0-1\n* Preoperative imaging diagnosis of advanced hepatocellular carcinoma (BCLC stage C or D, unsuitable for surgery)\n* Ultrasound or MRI indicating moderate to severe fatty liver (Fibroscan CAP \\> 268 dB\u002Fm or MR fat score \\> 10%)\n* Willing to use contraceptive measures during the trial period\n* Expected survival time ≥ 3 months\n* At least one measurable lesion (per RECIST 1.1) that has not been irradiated\n* Organ function levels (within 7 days before first study medication) must meet the following:\n* Hematopoietic function: ANC ≥ 1.5×10⁹\u002FL, PLT ≥ 100×10⁹\u002FL, Hb ≥ 90 g\u002FL, no transfusion within 14 days\n* Liver function: TBIL ≤ 1.5×ULN, AST\u002FALT\u002FALP ≤ 2.5×ULN, serum creatinine ≤ 1.5×ULN, CrCl ≥ 50 mL\u002Fmin, ALB ≥ 30 g\u002FL, Child-Pugh A\n* Coagulation function: INR and APTT ≤ 1.5×ULN or within therapeutic range if on anticoagulants\n* Renal function: urinary protein ≤ 1+ (or ≤1 g\u002F24h if \\>1+)\n* Cardiac function: ECG normal or clinically insignificant, LVEF \\> 50%\n* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to first dosing\n* Men and women of reproductive potential must use effective contraception during and for 12 months after treatment\n* Participants must voluntarily provide informed consent and have good compliance\n\nExclusion Criteria\n\n* Excessive alcohol consumption (weekly ethanol intake: males \\\u003C 210 g, females \\\u003C 140 g)\n* Tumor lesions previously treated with targeted therapy, immunotherapy, TACE, or radiotherapy\n* Pregnant or breastfeeding women, or positive pregnancy test at baseline\n* Central nervous system metastases diagnosed by CT, MRI, or PET-CT\n* Participation in another clinical drug or therapy trial within 4 weeks before first study dose\n* Major surgery within 4 weeks prior to first study dose, or incomplete recovery from surgery\n* Radiotherapy within 2 weeks before first study dose\n* History or presence of primary immunodeficiency or active autoimmune disease\n* History of organ transplantation or hematopoietic stem cell transplantation\n* Current use of immunosuppressants or corticosteroids (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks\n* Positive for HIV antibody or Treponema pallidum antibody, or active hepatitis B\u002FC infection\n* Allergy to recombinant humanized PD-1 monoclonal antibody, VEGF monoclonal antibody, or components\n* Symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical intervention\n* Severe cardiovascular disease within 12 months (e.g., CAD, CHF ≥ II, arrhythmias, MI)\n* Events within 6 months before first dose (e.g., DVT, PE, MI, PCI, ACS, CABG, stroke, TIA, embolism)\n* History of GI surgery, obstruction, bleeding, dysfunction, or malabsorption affecting drug absorption\n* Severe uncontrolled infection or comorbidity, or moderate\u002Fsevere renal impairment\n* Active pulmonary disease (interstitial pneumonia, COPD, asthma, tuberculosis history)\n* Abnormal coagulation (INR \\> 2.0, PT \\> 16 s), bleeding tendency, or thrombolytic\u002Fanticoagulant therapy (except prophylaxis)\n* Significant bleeding within 3 months (e.g., hemoptysis ≥ 2.5 mL, GI bleeding, varices, ulcers, vasculitis)\n* Known hereditary\u002Facquired bleeding or thrombotic disorders (e.g., hemophilia, thrombocytopenia)\n* History of substance abuse or mental disorders affecting compliance\n* Use of warfarin or coumarin derivatives within 14 days before or during treatment\n* Other severe acute\u002Fchronic conditions increasing risk or confounding results\n* Poor compliance or other conditions deemed unsuitable for trial participation",{"count":199,"type":21},20,[24,201],"PHASE3","This research plan involves a treatment approach for advanced hepatocellular carcinoma (HCC) in the context of metabolic-associated steatotic liver disease (MASLD). The study aims to compare the efficacy differences between sequential therapy and concurrent therapy using bevacizumab and atezolizumab for advanced HCC in MASLD. The research will focus on evaluating objective response rates, progression-free survival, disease control rates, and overall survival, while utilizing biomarker analysis to elucidate treatment mechanisms. Additionally, the study will examine treatment safety, including the incidence and severity of adverse events.",[204],"HCC - Hepatocellular Carcinoma",[206,207,208],"MASH","HCC","immunotherapy","2025-12-10",{"date":211,"type":36},"2025-12-16",{"date":213,"type":36},"2025-10-20",{"date":215,"type":21},"2026-08-30",{"name":42,"class":43},{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":224,"targetDuration":4,"studyType":22,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":44},"100585440","phase-1-a-clinical-study-of-multi-target-hi-tcr-t-cells-in-the-treatment-of-advanced-hepatocellular-carcinoma-100585440","NCT06902389","A Clinical Study of Multi-target Hi-TCR-T Cells in the Treatment of Advanced Hepatocellular Carcinoma","A Prospective Study on Super Hi-TCR-T Cells Targeting Nectin4\u002FNKG2DL\u002FTROP2\u002FB7H3\u002FGPC3\u002FFAP for the Treatment of Refractory\u002FRelapsed Advanced Liver Cancer and Other Solid Tumors","Inclusion criteria:\n\n1. Patients with advanced HCC who are inoperable and unsuitable for local therapy, and whose disease has progressed or cannot tolerate therapy after first - or second-line therapy, and who meet one of the following requirements: 1) have a histological or cytological diagnosis of HCC; 2) According to the National Health Commission's Guidelines for Primary Liver Cancer Diagnosis and Treatment (2024 edition), the clinical diagnosis was HCC;\n2. At least one measurable lesion was present according to RECIST1.1 and mRECIST criteria;\n3. The expressions of Nectin4, NKG2DL, TROP2, B7H3 and GPC3 in tumor tissues were detected by immunohistochemistry in primary and metastatic specimens or in white paraffin sections of previous pathological pathology (the expression of tumor cells with a target \\>10% is considered positive, and at least 2 targets are required to be positive), as well as the expression of FAP in tumor tissues;\n4. The patient's T cell quality (pre-experimental) assessment met the criteria: at least 5 times T cell proliferation within 3 days, and at least 10% lentivirus transduction efficiency;\n5. ECOG performance status score of 0-2;\n6. Child-Pugh score ≤6;\n7. Expected survival time of at least 3 months;\n8. No contraindications to peripheral blood mononuclear cell (PBMC) collection;\n9. Seven days prior to the first treatment with the study drug, organ function levels must meet the following requirements: Hematology: Hemoglobin (Hb) ≥90 g\u002FL; Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; Platelet count ≥75×10⁹\u002FL. Blood Biochemistry: Serum albumin ≥28 g\u002FL; Total bilirubin ≤2× upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3× ULN; Alkaline phosphatase (ALP) ≤3× ULN; Creatinine ≤1.5× ULN. Coagulation Function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN; Activated partial thromboplastin time (APTT) ≤1.5× ULN. Cardiac Function: Echocardiography confirms normal diastolic function; Left ventricular ejection fraction (LVEF) ≥50%; No severe arrhythmia. Pulmonary and Renal Function: No severe lung or kidney disease; No active pulmonary infection; Blood oxygen saturation ≥92% in room air.\n10. Serum pregnancy test results of women of childbearing age must be negative within 7 days before the first use of the study drug; Fertile men or women with the possibility of becoming pregnant must use a highly effective contraceptive method (such as oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicides) throughout the trial and continue contraception for 12 months after the end of treatment;\n11. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion criteria:\n\n1. Uncontrollable active infection (excluding HBV and\u002For HCV infections);\n2. active central nervous system disease, or known concomitant brain metastases with significant neurological\u002Fpsychiatric symptoms assessed by MMSE;\n3. Known allergy to 2 or more non-similar foods\u002Fdrugs, or known allergy to chemotherapy preconditioning drugs (such as cyclophosphamide, fludarabine);\n4. Any toxicity caused by previous antitumor therapy before chemotherapy preconditioning has not returned to grade 1 or below (CTCAE version 5.0);\n5. Patients who have participated in or are participating in clinical trials of other drugs\u002Ftherapies within 4 weeks prior to the first administration of the investigational drug;\n6. Major surgery had been performed\u002Freceived within 4 weeks prior to the first administration of the study drug or had not yet recovered from the side effects of the surgery, live vaccination, and radiotherapy within 2 weeks;\n7. Patients who are taking systemic hormone therapy for immunosuppressive purposes (dose \\>10mg\u002F day prednisone or other equivalent hormone) and continue to use within 2 weeks prior to treatment;\n8. Pregnant or lactating women;\n9. A history of other malignancies within the past 5 years, except cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin, early prostate cancer, and cervical carcinoma in situ;\n10. Active inflammatory bowel disease or digestive tract ulcer;\n11. HIV antibody or treponema pallidum antibody test results positive;\n12. A large amount of pleural fluid or ascites accompanied by clinical symptoms that require symptomatic treatment;\n13. A history of active lung disease (pneumonia, obstructive pulmonary disease, asthma) or active pulmonary tuberculosis;\n14. suffering from blood system diseases: leukemia, lymph nodes, myelodysplastic syndrome or myeloma;\n15. Except vitiligo accidental immune deficiency disease or autoimmune disease;\n16. Clinically significant bleeding symptoms or definite bleeding tendency occurred within 3 months before recruitment, such as cough\u002Fhemoptysis of 2.5ml or more per day, gastrointestinal bleeding, esophageal varicose veins with bleeding risk, hemorrhagic gastric ulcer or vasculitis. At baseline, if the stool was positive for occult blood, it could be re-examined; if it was still positive, gastroscopy was required; if the gastroscopy indicated severe esophageal and gastric fundus varices, it could not be included in the group (except those who were excluded by gastroscopy within 3 months before enrollment).\n17. Have any clinical problems beyond your control, including but not limited to:\n\n1\\) Persistent or active (severe) infection; 2) poorly controlled hypertension (persistent blood pressure \\>150\u002F90mmHg); 3) Poorly controlled diabetes; 4) Heart disease (Class III\u002FIV congestive heart failure or heart block as defined by the Heart Society of New York); 5) The following conditions occurred within 6 months before the first medication: deep vein thrombosis or pulmonary embolism; Myocardial infarction; Severe or unstable arrhythmia or angina; Percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; Cerebrovascular accident, transient ischemic attack, cerebral embolism.\n\n18.have obvious genetic diseases; 19. have received a stem cell transplant or an organ transplant; 20.Those who have a history of psychotropic drug abuse and cannot quit or have a history of mental disorders; 21.other severe, acute, or chronic medical conditions or abnormalities in laboratory tests that the investigator determines may increase the risks associated with participation in the study or may interfere with the interpretation of the study results; 22.Patients who were judged by the investigator to have poor compliance or other conditions that made them unfit to participate in the trial.",{"count":225,"type":21},30,[227,24],"PHASE1","This study is a prospective, single-arm, open, single-center clinical trial initiated by the investigator. The principal investigators are professors Shen Feng and Zhang Xiaofeng from The Third Affiliated Hospital of Navy Military Medical University (Shanghai Eastern Hepatobiliary Surgery Hospital).\n\nPrimary Objectives:\n\n1. To evaluate the safety and tolerability of super Hi-TCR-T cells targeting Nectin4\u002FNKG2DL\u002FTROP2\u002FB7H3\u002FGPC3\u002FFAP in the treatment of refractory\u002Frecurrent advanced hepatocellular carcinoma (HCC) and other solid tumors.\n2. To assess the efficacy of super Hi-TCR-T cells targeting Nectin4\u002FNKG2DL\u002FTROP2\u002FB7H3\u002FGPC3\u002FFAP in the treatment of refractory\u002Frecurrent advanced HCC and other solid tumors, focusing on progression-free survival (PFS).\n\nSecondary Objectives:\n\n1. To evaluate the efficacy of super Hi-TCR-T cells targeting Nectin4\u002FNKG2DL\u002FTROP2\u002FB7H3\u002FGPC3\u002FFAP in the treatment of refractory\u002Frecurrent advanced HCC and other solid tumors at 1, 3, 6, and 12 months, assessing disease control rate (DCR: CR+PR+SD), time to progression (TTP), and overall survival (OS).\n2. To observe and assess the quality of life (QOL score) of patients receiving super Hi-TCR-T cell therapy targeting Nectin4\u002FNKG2DL\u002FTROP2\u002FB7H3\u002FGPC3\u002FFAP for refractory\u002Frecurrent advanced HCC and other solid tumors.\n\nExploratory Objectives:\n\n1. To evaluate the relationship between the in vivo expansion and persistence of super Hi-TCR-T cells targeting Nectin4\u002FNKG2DL\u002FTROP2\u002FB7H3\u002FGPC3\u002FFAP and disease progression.\n2. To explore potential predictive biomarkers. Thirty patients are planned to be recruited for this study. The subjects were advanced HCC patients who had failed second-line therapy or could not tolerate therapy. The expression levels of Nectin4, NKG2DL, TROP2, B7H3, GPC3 and FAP were detected by immunohistochemistry in the pathologic tissues of the primary and metastatic sites. Meanwhile, 20ml peripheral blood was extracted to evaluate the quality of T cells (in vitro proliferation activity and lentiviral transduction efficiency). Patients with positive expression rates of at least 2 targets (excluding FAP) \\>10% and qualified T cell quality could be considered for inclusion.\n\nPeripheral blood lymphocytes were collected and Hi-TCR-T cells targeting three targets (including FAP) were prepared. After pretreatment with fludarabine + cyclophosphamide chemotherapy (FC regimen), the prepared Hi-TCR-T cells were transfused back, in which the dose of Hi-TCR-T cells at each target was 3.0x106 cells\u002Fkg body weight (the dose was the extended therapeutic dose obtained in the previous clinical trial), and the drug was administered by peripheral intravenous infusion. To improve efficacy, Hi-TCR-T cell retransfusion can be prepared by increasing the cell dose of the target or changing the combination of the target as the disease progresses and evaluated by a multidisciplinary team (MDT).\n\nSafety and efficacy evaluation and exploratory studies were conducted after reinfusion of Hi-TCR-T cells from screening multiple targets:\n\n1. Safety assessment: at baseline, 4, 7, 10, 2, 3, 4, 8, 12, 16, 20, 6, 9 and 12 months after cell therapy;\n2. Effectiveness evaluation: at baseline, 4, 12, 6, 9, 12, 24, and 36 months after cell therapy. Safety assessment: At baseline, 4, 7, 10, 2, 3, 4, 8, 12, 16, 20, 6, 9, and 12 months after cell therapy;\n3. Exploratory study: 20ml peripheral blood was collected from patients at baseline, 7 days, 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 6 months, 9 months, 12 months after cell therapy, to explore the relationship between the proliferation and survival time of Hi-TCR-T cells in vivo and the changes of disease and peripheral blood cytokines.\n\nThe start time of the study was defined as the date the first patient was enrolled; The end time of the study was defined as 12 months after the end of medication for the final patient, or all patients died, or all patients had lost follow-up or withdrawn consent (whichever occurred first). The planned recruitment period is 12-18 months.",[230],"Advanced Hepatocellular Carcinoma (HCC)",[232,233],"Hi-TCR-T","Advanced hepatocellular carcinoma","2025-09-01",{"date":236,"type":36},"2025-09-03",{"date":238,"type":36},"2025-07-30",{"date":240,"type":21},"2028-04-07",{"name":42,"class":43},{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":44},"100584713","phase-2-ql1706-combined-with-lenvatinib-and-gemox-as-first---line-treatment-for-unresectable-biliary-tract-tumors-100584713","NCT06892925","QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors","QL1706 Combined With Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors: A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)","Spring","Inclusion Criteria:\n\n1. The patient voluntarily participates in the trial, provides full informed consent, signs a written consent form, and demonstrates good compliance.\n2. The patient is aged 18 or older, regardless of gender.\n3. The patient has a histologically confirmed diagnosis of unresectable locally advanced or metastatic biliary tract cancer, including cholangiocarcinoma (intrahepatic and extrahepatic) and gallbladder cancer.\n4. The patient is newly diagnosed with unresectable locally advanced or metastatic biliary tract cancer and has not received prior systemic therapy.\n5. Patients who have previously received radical treatment (surgery, adjuvant chemotherapy, and\u002For radiotherapy) are allowed, provided disease recurrence is \\>6 months after treatment. Those who received adjuvant therapy (chemotherapy and\u002For radiotherapy) and are \\>6 months post-treatment are also eligible.\n6. At baseline, the patient has at least one measurable lesion according to RECIST v1.1 that can be repeatedly and accurately measured.\n7. The patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1.\n8. The patient has an expected survival of ≥12 weeks.\n9. The patient has adequate organ and bone marrow function, meeting the following criteria (within 14 days before starting study treatment):\n\n   * Hematology (no transfusions, granulocyte colony-stimulating factor \\[G-CSF\\], or corrective medications within 14 days of screening): Hemoglobin (Hb) ≥90 g\u002FL; Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL; Platelets (PLT) ≥75×10⁹\u002FL.\n   * Biochemistry (no albumin transfusion within 14 days of screening): Total bilirubin (BIL) ≤2×upper limit of normal (ULN) (≤3×ULN for Gilbert's syndrome patients); Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤3.0×ULN (≤5×ULN for liver metastases patients); Serum creatinine (Cr) ≤1.5×ULN or endogenous creatinine clearance rate ≥50 ml\u002Fmin (Cockcroft-Gault formula).\n   * For males: Cr clearance = ((140 - age) × weight) \u002F (72 × serum Cr)\n   * For females: Cr clearance = ((140 - age) × weight) \u002F (72 × serum Cr) × 0.85 (weight in kg; serum Cr in mg\u002FmL).\n10. HBV-infected patients (HBsAg and\u002For anti-HBc positive) with detectable HBV DNA (≥10 IU\u002FmL or above local laboratory detection limit) must receive antiviral therapy before study drug administration, as per institutional practice, to ensure viral suppression. They must continue antiviral therapy during the study and for 6 months after the last dose. Anti-HBc-positive patients without detectable HBV DNA (\\\u003C10 IU\u002FmL or below detection limit) do not require antiviral therapy unless HBV DNA exceeds 10 IU\u002FmL or the local laboratory detection limit during the study.\n11. Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days before the first dose.\n12. Women of childbearing potential engaging in sexual activity with non-sterilized males must use acceptable contraception from screening until 120 days after the last study drug dose.\n13. Non-sterilized male patients engaging in sexual activity with women of childbearing potential must use effective contraception from screening until 120 days after the last dose. Contraception cessation after this period should be discussed with the investigator.\n14. The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\n1. Cholangiocarcinoma of rare histopathological types confirmed by histology or cytology, such as ampullary cancer, small cell cancer, neuroendocrine tumors, sarcoma, and mucinous cystic tumors.\n2. Subjects with other malignancies within 5 years before enrollment, except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been cured.\n3. History of leptomeningeal carcinoma, brain metastasis.\n4. Participation in another interventional clinical study within the past 3 months, or concurrent enrollment in another clinical study, unless it is an observational, non-interventional study or the follow-up period of an interventional study.\n5. Any disease evidence deemed by the investigator to disqualify the subject, such as uncontrolled hypertension, active bleeding disorder, active infection, active interstitial lung disease, severe chronic gastrointestinal disease related to diarrhea, psychiatric illness, or social condition, or a history of allogeneic organ transplantation.\n6. Severe cardiovascular disease history: NYHA Class II or above heart failure, unstable angina, myocardial infarction, uncontrolled arrhythmia, or cerebrovascular accident within 12 months before drug administration; echocardiogram showing LVEF \\\u003C50%; QTc \\>480ms (Fridericia method, average of three consecutive measurements 2 minutes apart if QTc is abnormal); poorly controlled hypertension (systolic BP ≥150 mmHg and\u002For diastolic BP ≥100 mmHg, based on the average of ≥2 measurements); history of hypertensive crisis or encephalopathy.\n7. Active autoimmune disease within the past 2 years or a history of autoimmune disease that may recur, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (excluding patients controlled by hormone replacement therapy).\n8. Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1\u002FL1, CTLA-4, TIGIT, LAG3 antibodies), immune checkpoint agonists (e.g., CD40, CD137, OX40 antibodies), or other immunotherapy for tumor immune mechanisms, except therapeutic antitumor vaccines.\n9. Co-infection with HBV (HBsAg and\u002For anti-HBcAb positive with detectable HBV DNA) and HCV (anti-HCV antibody positive), or HBV and HDV (anti-HDV antibody positive).\n10. Severe peptic ulcer, gastritis, gastrointestinal perforation, abdominal fistula, obstruction, intra-abdominal abscess, or acute gastrointestinal hemorrhage within 6 months before first dose; acute exacerbation of COPD within 1 month before first dose.\n11. Life-threatening bleeding event within 3 months before first study drug administration, including those requiring transfusion, surgery, local treatment, or ongoing medication.\n12. Major surgery or severe trauma within 30 days before first dose, or planned major surgery within 30 days after first dose (investigator's decision); minor local surgery within 3 days before first dose (excluding central venous catheter placement and venous port implantation).\n13. Pregnant or breastfeeding women; men or women of reproductive potential unwilling to use effective contraception from screening until 90 days after last study intervention dose or 180 days after last investigational drug dose.\n14. Known allergy or hypersensitivity to any study intervention or its excipients.\n15. Other patients deemed unsuitable for inclusion by the treating physician.",{"count":251,"type":21},59,[24],"QL1706 Combined with Lenvatinib and GEMOX as First - Line Treatment for Unresectable Biliary Tract Tumors：A Single - Arm, Open - Label, Multi - Center, Prospective Phase II Clinical Trial (Spring Study)",[255],"Biliary Tract Tumors",[257,258,259,260],"QL1706","Lenvatinib","GEMOX","First - Line Treatment","2025-07-07",{"date":263,"type":36},"2025-07-10",{"date":265,"type":36},"2025-06-14",{"date":267,"type":21},"2029-04",{"name":42,"class":43},{"id":270,"slug":271,"hasResults":11,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":4,"eligibilityCriteria":275,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":290,"locationsCount":4},"100579013","phase-4-inetetamab-plus-chemotherapy--pd-1pd-l1-in-her2-advanced-biliary-cancer-100579013","NCT06818773","Inetetamab Plus Chemotherapy ± PD-1\u002FPD-L1 in HER2+ Advanced Biliary Cancer","Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1\u002FPD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer","Inclusion Criteria:\n\n* Males or females aged ≥18 years;\n* Histologically confirmed HER2-positive metastatic biliary tract cancer;\n* ECOG performance status of 0 to 1;\n* No prior treatment with anti-HER2 therapies;\n* Patients have not received any systemic anticancer treatment in the recurrent\u002Fmetastatic setting;\n* Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and\u002For radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;\n* Presence of at least one measurable lesion;\n* Adequate function of major organs as defined by the following criteria;\n* Estimated survival of ≥3 months;\n* Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Known allergy or contraindication to any component of the study drugs;\n* Previous treatment with anti-HER2 therapies;\n* Prior use of immunotherapy;\n* Use of immunosuppressive agents within 14 days before the first dose, except:\n\nIntranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg\u002Fday prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)\n\n* Known active central nervous system metastases or carcinomatous meningitis;\n* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;\n* Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;\n* Severe cardiac disease;\n* Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;\n* Neuropathy ≥ Grade I per NCI criteria;\n* Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;\n* History of immunodeficiency;\n* Participation in another drug trial within 4 weeks before screening;\n* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;\n* Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.",{"count":277,"type":21},35,[279],"PHASE4","To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.",[282,283],"Metastatic Biliary Tract Cancer","HER2 Positive","2025-02-07",{"date":286,"type":36},"2025-02-10",{"date":288,"type":21},"2025-02",{"date":165,"type":21},{"name":42,"class":43},{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":305,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100556877","phase-2-pemigatinib-combined-with-durvalumab-for-previously-treated-biliary-tract-carcinoma-100556877","NCT06530823","Pemigatinib Combined With Durvalumab for Previously Treated Biliary Tract Carcinoma","Pemigatinib Combined With Durvalumab for the Safety and Efficacy in Second-Line Treatment of Biliary Tract Cancer: A Single-Arm, Multicenter Phase II Clinical Trial","Inclusion Criteria:\n\n1. Age ≥18 years, men and women;\n2. ECOG performance status of 0-1;\n3. Histologically confirmed advanced gallbladder cancer or cholangiocarcinoma patients who have received one prior line of therapy;\n4. Adult patients with advanced, metastatic, or unresectable cholangiocarcinoma or gallbladder cancer confirmed to have FGFR2 fusion or rearrangement;\n5. Diagnosed with locally advanced disease according to the 8th edition of AJCC, with clinical staging of cT3\u002F4NxM0\u002F1 for gallbladder cancer, intrahepatic cholangiocarcinoma, or hilar cholangiocarcinoma, or cT2N2M0, cT3\u002F4NxM0\u002F1 for distal cholangiocarcinoma based on enhanced CT or MRI;\n6. Use of contraception during the study period;\n7. Life expectancy ≥3 months;\n8. All patients must provide tumor tissue specimens (fresh or paraffin-embedded) for FGFR2 expression analysis before enrollment and after surgery (5 slides within 3 years are required);\n9. At least one measurable lesion according to RECIST 1.1 criteria, which has not been irradiated;\n10. Within 7 days prior to the first administration of the study drug, the organ function levels of the enrolled patients must meet the following requirements:\n\n    1. Hematopoietic function: Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, platelet count (PLT) ≥ 100×10\\^9\u002FL, hemoglobin (Hb) ≥90g\u002FL, and no blood transfusion or component blood transfusion within 14 days prior to testing;\n    2. Hepatic function: Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (APK) ≤2.5 times ULN, serum creatinine ≤1.5 times ULN and creatinine clearance (based on the Cockcroft-Gault formula) ≥50mL\u002Fmin, serum albumin (ALB) ≥30g\u002FL, Child-Pugh class A;\n    3. Coagulation function: For patients not receiving anticoagulant therapy, international normalized ratio (INR), activated partial thromboplastin time (APTT) ≤1.5 times ULN; patients receiving anticoagulant therapy should maintain therapeutic levels of anticoagulants;\n    4. Thyroid function: Thyroid-stimulating hormone (TSH) ≤1×ULN, if TSH \\>1×ULN, free T3 (FT3) and free T4 (FT4) levels should also be assessed, and if normal, the patient may be enrolled;\n    5. Renal function: Urine protein ≤1+. If urine protein \\>1+, a 24-hour urine protein test is required, and the total amount must be ≤1 gram for enrollment;\n    6. Normal cardiac function, i.e., normal electrocardiogram or clinically insignificant abnormalities, and left ventricular ejection fraction (LVEF) \\>50% as shown by echocardiography;\n11. Serum pregnancy test results must be negative within 7 days prior to the first administration of the trial medication for women of childbearing age; men with reproductive capacity or women who may become pregnant must use highly effective contraception (e.g., oral contraceptives, intrauterine devices, abstinence, or barrier methods combined with spermicides) throughout the trial and continue for 12 months after treatment;\n12. Volunteers willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Patients who have not received standard first-line treatment for advanced biliary tract tumors;\n2. Pregnant or breastfeeding women, and women of childbearing age with positive pregnancy test results at baseline;\n3. Patients diagnosed with central nervous system metastasis by CT\u002FMR\u002FPET-CT;\n4. Patients who have previously received live vaccine administration or other antitumor treatments such as radiotherapy;\n5. Patients who have participated in or are currently participating in other drug or therapy clinical trials within 4 weeks prior to the first administration of the study medication;\n6. Patients who have undergone major surgical procedures within 4 weeks prior to the first administration of the study medication or have not recovered from the side effects of such surgery, or patients who have undergone radiotherapy within 2 weeks prior to the first administration of the study medication;\n7. Patients with any primary immunodeficiency, active autoimmune disease, or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, vitiligo, patients with a history of asthma who have completely resolved in childhood and do not require any intervention in adulthood may be included; patients with asthma requiring medical intervention with bronchodilators are excluded;\n8. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, and patients currently using immunosuppressants or corticosteroids for immunosuppressive purposes (dosage \\>10mg\u002Fday prednisone or other equivalent corticosteroids) and still in use within 2 weeks prior to enrollment;\n9. Patients with other malignancies within the past 5 years, except for cured skin basal cell or squamous cell carcinoma, superficial bladder cancer, early prostate cancer, in situ cervical cancer, or breast cancer;\n10. Patients who have received hematopoietic growth factors within 1 week prior to the first administration of the study medication, such as granulocyte colony-stimulating factor (G-CSF), erythropoietin, etc.;\n11. Patients with positive HIV antibodies or syphilis antibodies, and patients with active hepatitis B or C;\n12. Known allergies to recombinant humanized PD-L1 monoclonal antibody drugs and their components;\n13. Patients with symptomatic pleural effusion, pericardial effusion, or ascites requiring clinical treatment;\n14. Patients with severe cardiovascular diseases within the last 12 months, such as clinically significant coronary heart disease, NYHA≥II congestive heart failure, uncontrolled arrhythmias, myocardial infarction;\n15. Within 6 months prior to the first administration of the study medication, the following conditions have occurred: deep vein thrombosis or pulmonary embolism; myocardial infarction; severe or unstable arrhythmias or angina; percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass grafting; cerebrovascular accident, transient ischemic attack, cerebral embolism.\n16. Patients who have undergone any type of gastrointestinal surgery, or have upper gastrointestinal obstruction, bleeding, digestive dysfunction, or malabsorption syndrome that may affect the absorption of the study medication;\n17. Concurrent severe uncontrollable infections or other severe uncontrollable comorbidities, moderate or severe renal impairment;\n18. Active pulmonary diseases, such as interstitial pneumonia, pneumonia, chronic obstructive pulmonary disease, asthma, or a history of active tuberculosis.\n19. Abnormal coagulation function (INR\\>2.0, PT\\>16s), with a tendency to bleed or currently receiving thrombolytic or anticoagulant therapy, prophylactic use of low-dose aspirin, low molecular weight heparin is allowed;\n20. Significant clinical bleeding symptoms or a clear tendency to bleed within 3 months, such as coughing or expectorating blood ≥2.5ml, history of gastrointestinal bleeding, esophageal and gastric varices with bleeding risk, bleeding gastric ulcers or patients with vasculitis, etc.; if the baseline fecal occult blood test is positive, it can be retested, and if it is still positive after retesting, a gastroscopy is required, and if gastroscopy indicates severe esophageal and gastric varices, the patient may not be enrolled (patients who have undergone gastroscopy within 3 months and excluded such conditions are excluded);\n21. Known genetic or acquired bleeding and thrombotic tendencies, such as hemophilia, coagulation disorders, thrombocytopenia, etc.;\n22. History of substance abuse that cannot be quit or history of mental disorders.\n23. Use of warfarin or any other coumarin derivative anticoagulants within 14 days prior to the first administration of the study medication.\n24. Other severe, acute, or chronic medical diseases or laboratory abnormalities that the investigator judges may increase the risk associated with participating in the study or may interfere with the interpretation of the study results.\n25. Patients deemed to have poor compliance by the investigator, or other conditions that make them unsuitable for participating in this trial.",{"count":299,"type":21},38,[24],"This study is a single-arm, multicenter Phase II clinical trial designed to preliminarily assess the safety and efficacy of the combination therapy of pemigatinib and durvalumab in the second-line treatment of patients with advanced malignant biliary tract cancer.\n\nThe study anticipates enrolling 38 participants characterized by the following criteria: 1) A confirmed diagnosis of advanced, metastatic, or unresectable biliary tract cancer by histopathological examination; 2) Presence of FGFR2 fusion or rearrangement confirmed by testing; 3) Prior receipt of first-line treatment for biliary tract cancer.\n\nThe primary questions the study aims to address are:\n\n1. Can the combination of pemigatinib and durvalumab improve the prognosis of participants with previously treated biliary tract cancer (BTC)?\n2. What is the safety profile of the treatment with pemigatinib and durvalumab?\n\nParticipants will receive:\n\n1. Oral administration of 13.5 mg pemigatinib once daily, in combination with durvalumab 1500 mg via intravenous infusion.\n2. Follow-up visits will be scheduled every 6 weeks.\n\nInvestigators will observe and document the objective tumor response rate of the participants, as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and adverse events.",[303,304],"Biliary Tract Carcinoma","Cholangiocarcinoma",[306,307,308,309,208],"biliary tract carcinoma","cholangiocarcinoma","FGFR mutation","targeted thearpy","2024-07-28",{"date":312,"type":36},"2024-07-31",{"date":314,"type":21},"2024-08-01",{"date":316,"type":21},"2028-08-01",{"name":42,"class":43},""]