[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"combined-hepatocellular-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:combined-hepatocellular-cholangiocarcinoma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100611697","phase-2-phase-ii-clinical-study-on-the-efficacy-and-safety-of-the-combination-of-cadonilimab-and-capecitabine-in-adjuvant-therapy-for-combined-hepatocellular-carcinoma-and-intrahepatic-cholangiocarcinoma-100611697",false,"NCT07243951","Phase II Clinical Study on the Efficacy and Safety of the Combination of Cadonilimab and Capecitabine in Adjuvant Therapy for Combined Hepatocellular Carcinoma and Intrahepatic Cholangiocarcinoma","Inclusion Criteria:\n\n1. Age 18-75 years.\n2. ECOG Performance Status ≤ 1.\n3. Pathologically confirmed combined hepatocellular carcinoma and intrahepatic cholangiocarcinoma (cHCC\u002FCCA), with R0 resection and classified as Stage IB, Stage II, Stage IIIA, Stage IIIB, or Stage IA (G3) according to AJCC TNM Staging System (8th Edition, 2017).\n4. No extrahepatic metastasis.\n5. Post-operative Child-Pugh liver function class A; ECOG PS score: 0-1.\n6. For subjects with chronic HBV infection, HBV-DNA must be \\\u003C500 IU\u002FmL. HBsAg-positive patients must receive antiviral therapy according to the \"Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)\". HCV-RNA positive patients must receive antiviral therapy according to the \"Guidelines for the Prevention and Treatment of Hepatitis C (2015)\" and have normal liver function.\n7. Adequate organ function, defined as follows:\n\n(1) Hematological tests (no blood transfusion or use of hematopoietic growth factors within 14 days prior to screening):\n\n1. Hemoglobin (HB) ≥90 g\u002FL\n2. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL\n3. Platelet count (PLT) ≥75×10⁹\u002FL (2) Biochemical tests (no blood transfusion or blood products within 14 days prior to screening):\n\n1\\) Albumin (ALB) ≥29 g\u002FL 2) ALT and AST \\\u003C2.5 × ULN 3) Total bilirubin (TBIL) ≤1.5 × ULN 4) Creatinine (Cr) ≤1.5 × ULN (3) International Normalized Ratio (INR) ≤2.3, or Prothrombin Time (PT) prolongation ≤6 seconds beyond the normal control range.\n\n8\\. Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 14 days before initiating study treatment and be willing to use effective and reliable methods of contraception during the trial and for one year after the last dose of the study drug.\n\n9\\. Subjects voluntarily join the study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up.\n\n10\\. No evidence of tumor recurrence or metastasis at baseline examination.\n\nExclusion Criteria:\n\n1. Pathological diagnosis of hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or hilar cholangiocarcinoma.\n2. Incomplete tumor resection (non-R0), or postoperative pathology indicating a diagnosis other than cHCC\u002FCCA.\n3. History of or concurrent other malignancies, except for cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, carcinoma in situ of the breast, etc. Concurrent autoimmune diseases (e.g., autoimmune liver disease, systemic lupus erythematosus).\n4. Child-Pugh class B or C; history or presence of manifestations of hepatic decompensation (e.g., ascites, hepatic encephalopathy, upper gastrointestinal bleeding, etc.).\n5. Known hereditary or acquired bleeding or thrombotic tendencies, such as hemophilia.\n6. Presence of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 2 months prior to study participation.\n7. Myocardial ischemia of grade II or above, myocardial infarction, or poorly controlled arrhythmias (including QTcF interval ≥450 ms for males or ≥470 ms for females; QTc interval calculated by Fridericia's formula). Cardiac insufficiency of NYHA Class III-IV or left ventricular ejection fraction (LVEF) \\\u003C50% on echocardiography.\n8. Severe cardiopulmonary dysfunction or severe renal insufficiency.\n9. History of thrombotic\u002Fembolic events within the past 6 months, such as cerebrovascular events (including transient ischemic attack) or pulmonary embolism.\n10. Inability to swallow, chronic diarrhea, or intestinal obstruction that significantly affects drug administration and absorption.\n11. Untreated active hepatitis (Hepatitis B: HBsAg positive with abnormal liver function and HBV-DNA ≥500 IU\u002FmL; Hepatitis C: HCV-RNA positive with abnormal liver function).\n12. Human Immunodeficiency Virus (HIV) infection.\n13. Active infection or unexplained fever (\\>38.5°C) occurring during the screening period or before the first dose.\n14. Receipt of any vaccine within 30 days prior to enrollment. Planned or prior history of allogeneic organ or bone marrow transplantation, including liver transplantation.\n15. History or current presence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, or other conditions that may interfere with the detection and management of suspected drug-related pulmonary toxicity.\n16. Hypertension that cannot be well controlled with antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n17. Coagulation dysfunction (PT \\>16s, APTT \\>43s, TT \\>21s, Fibrinogen \\\u003C2 g\u002FL), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.\n18. Significant clinically significant bleeding symptoms or definite bleeding tendency within 3 months before the first dose, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or higher, or presence of vasculitis.\n19. Active, known, or suspected autoimmune disease (including but not limited to uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism, asthma requiring bronchodilators, etc.). Subjects in a stable state not requiring systemic immunosuppressive therapy are allowed.\n20. Requirement for systemic treatment with corticosteroids (\\>10 mg\u002Fday prednisone equivalent) or other immunosuppressants within 14 days prior to study drug administration. Inhaled or topical steroids and adrenal replacement therapy at doses \\>10 mg\u002Fday prednisone equivalent are permitted in the absence of active autoimmune disease.\n21. Prior treatment with other PD-1 antibodies or other immunotherapy targeting PD-1\u002FPD-L1. Known history of severe allergy to any monoclonal antibody, anti-angiogenic targeted drugs, platinum agents, fluorouracil, or any component of the study drugs.\n22. Requirement for long-term anticoagulation therapy with warfarin or heparin; requirement for long-term antiplatelet therapy (aspirin ≥300 mg\u002Fday or clopidogrel ≥75 mg\u002Fday).\n23. Known history of psychotropic drug abuse or drug addiction. Pregnant or lactating women.\n24. Any other factor considered by the investigator to be likely to lead to premature termination of the study, such as other severe diseases, significant laboratory abnormalities, or accompanying familial or social factors that may affect the subject's safety or the collection of trial data and samples.","ALL","18 Years","75 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Title: A Study of Cadonilimab Combined with Capecitabine After Surgery for Mixed Type Liver Cancer\n\nThis is a phase II clinical trial. The main purpose of this study is to find out if using two drugs together, cadonilimab (an immunotherapy drug) and capecitabine (a chemotherapy drug), can help prevent the cancer from coming back after surgery in patients with a specific type of liver cancer called combined hepatocellular-cholangiocarcinoma (cHCC\u002FCCA). This type of liver cancer is rare and has a high chance of returning even after successful surgery.\n\nThe study will involve about 75 patients who have had their tumor completely removed but are still at medium to high risk of the cancer returning. All participants in the study will receive the same combination of drugs. Cadonilimab is given through a vein every three weeks. Capecitabine is taken as a pill twice a day for two weeks, followed by one week off. This cycle repeats for up to 8 cycles (about 6 months), or until the cancer comes back or side effects become too severe.\n\nResearchers will primarily measure how long patients live without the cancer returning (Recurrence-Free Survival). They will also track how long patients live overall (Overall Survival), and carefully record any side effects to understand the safety of this treatment combination.\n\nThe study hypothesis is that this combination therapy will significantly prolong RFS compared to historical outcomes with surgery alone, while demonstrating acceptable safety.",[26,27],"Combined Hepatocellular-cholangiocarcinoma","Liver Neoplasms",[29,30,31,32,33,34,35,36,37],"Cadonilimab","Capecitabine","Phase II Clinical Trial","Bispecific Antibody","PD-1","CTLA-4","Recurrence-Free Survival","Immunotherapy","Adjuvant Therapy","NOT_YET_RECRUITING","2025-11-21",{"date":41,"type":42},"2025-11-24","ACTUAL",{"date":44,"type":20},"2025-11-28",{"date":46,"type":20},"2028-06-30",{"name":48,"class":49},"Shanghai Zhongshan Hospital","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":64,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100581351","novel-subtypes-and-treatment-strategies-of-patients-with-unresectable-combined-hepatocellular-cholangiocarcinoma-based-on-multimodal-data-100581351","NCT06849180","Novel Subtypes and Treatment Strategies of Patients with Unresectable Combined Hepatocellular Cholangiocarcinoma Based on Multimodal Data","Novel Subtypes and Treatment Strategies of Patients with Unresectable Mixed Hepatocellular Cholangiocarcinoma Based on Multimodal Data","Inclusion Criteria:\n\n1. age ≥18 years; diagnosis of CHC confirmed by histology or cytology;\n2. patients with unresectable or metastatic CHC diagnosed on the basis of unresectable CHC who have received prior local therapy, systemic therapy, or a combination of both and have at least one measurable lesion (RECIST v1.1);\n3. survival time ≥ 3 months;\n4. ECOG PS 0-2;\n5. Child-Pugh A\u002FB.\n\nExclusion Criteria:\n\n1. pregnant women, lactating women, and men and women of childbearing age who are unwilling or unable to use effective contraception.\n2. history of other malignant tumors within the past five years, unless these tumors have been completely treated and have been free of active disease for five years prior to the first dose and are at low risk of recurrence.\n3. fully treated carcinoma in situ with no evidence of disease.\n4. history of gastrointestinal bleeding or significant bleeding tendency (e.g., with known active ulcers, fecal occult blood, etc.) within the past six months that precludes inclusion in the study; gastroscopy is required if there is persistent fecal occult blood.\n5. substantial organ transplantation or bone marrow transplantation within two years prior to the first dose, or active autoimmune disease requiring systemic therapy.\n6. other conditions that the investigator deems unsuitable for inclusion in the study. Inadequate information, such as incomplete data from laboratory tests, missing or poor quality imaging data, no prognostic information, etc., that the investigator considers unsuitable for inclusion in the study.",{"count":58,"type":20},198,"OBSERVATIONAL","This study focused on exploring new comprehensive treatment strategies for patients with unresectable combined hepatocellular-cholangiocarcinoma, classifying patients with CHC subtypes based on the combination of artificial intelligence and multi-omics, and exploring the optimal treatment strategies for patients with different subtypes, helping clinicians to screen the most beneficial groups of various treatment schemes, and providing new ideas for safe treatment of high-risk patients.",[26,62,63],"Combined Hepatocellular Carcinoma and Cholangiocarcinoma","Combined Hepatocellular and Cholangiocarcinoma",[65,66],"CHC","cHCC-ICC","RECRUITING","2025-02-23",{"date":70,"type":42},"2025-02-27",{"date":72,"type":42},"2024-12-31",{"date":74,"type":20},"2026-02-28",{"name":76,"class":49},"Zhongda Hospital",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100518636","phase-1-gemox-combined-with-anlotinib-and-sintilimab-in-advanced-chcc-icc-100518636","NCT06033118","Gemox Combined With Anlotinib and Sintilimab in Advanced cHCC-ICC","Gemox Combined With Anlotinib and Sintilimab in Advanced Combined Hepatocellular-cholangiocarcinoma: an Exploratory Study","Inclusion Criteria:\n\n1. .Age 18-75 years;\n2. .Histologically or cytologically confirmed diagnosis of aCombined hepatocellular-cholangiocarcinoma;\n3. .Non resectable or metastatic cHCC-ICC patients who have not received systemic treatment or first-line treatment progress (only non arotinib Targeted therapy or non GEMOX chemotherapy) in the past, and have at least one measurable lesion (RECIST v1.1);\n4. .Life expectancy ≥ 3 months;\n5. .ECOG PS 0-1;\n6. .Child Pugh A\u002FB ≤ 7;\n7. .Adequate organ function including the following:Total bilirubin ≤1.5 times upper limit of normal (ULN),Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN,Alkaline phosphatase≤2.5×ULN (If the tumor invaded the liver, ≤3×ULN), Serum creatinine≤1.5×ULN,Serum amylase and lipase≤1.5×ULN,International standardized ratio (INR)\u002Fpartial prothrombin time (PTT)≤1.5×ULN;Platelet count ≥ 75,000 \u002Fmm3.Hemoglobin (Hb) ≥ 9 g\u002FdL.Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3.\n8. .Strict contraception.\n9. .Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.\n\nExclusion Criteria:\n\n1. Has a history of severe allergic reactions to chimeric, human or humanized antibodies, or fusion proteins.\n2. Pregnant or lactating women, men and women of childbearing age who are unwilling or unable to take effective contraceptive measures;\n3. History of other malignant tumors in the past 5 years, except for malignant tumors that have received treatment for the purpose of cure, and have no known active diseases for ≥ 5 years before the first administration, and have a low potential risk of recurrence; Fully treated non Melanoma skin cancer or malignant lentigo without disease evidence; Fully treated Carcinoma in situ, no disease evidence;\n4. Moderate or higher amounts of pleural and ascitic fluid with clinical symptoms;\n5. Active bleeding or abnormal coagulation function (PT\\>16s, APTT\\>43s, INR\\>1.5) × ULN), with a tendency to bleed or undergoing thrombolysis, anticoagulation, or antiplatelet therapy;\n6. Hepatic encephalopathy;\n7. Within the past 6 months, there has been a history of gastrointestinal bleeding or a clear tendency for gastrointestinal bleeding, such as known local active ulcer lesions, fecal occult blood+or above, which cannot be included in the group; If there is continuous fecal occult blood, gastroscopy should be performed;\n8. Patients with severe gastroesophageal varices who require interventional treatment;\n9. Untreated active hepatitis B. (Note: Hepatitis B patients who receive antiviral treatment and whose HBV Viral load is less than 2000IU\u002Fml can be allowed to participate in the study)\n10. Active hepatitis C, that is, those who are anti-HCV positive or HCV-RNA positive and have abnormal liver function;\n11. Having a history of psychotropic substance abuse, unable to quit, or having a history of mental disorders;\n12. Patients who received solid organ transplantation or bone marrow transplantation, or had active autoimmune diseases requiring systemic Sex therapy within 2 years before the first administration;\n13. Existence of immune deficiency diseases or HIV infection;\n14. There has been objective evidence that Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and serious impairment of lung function exist in the past or at present;\n15. Major surgery on the liver or other parts has been performed within 4 weeks before the first administration, or minor surgery (such as simple resection, tooth extraction, etc.) has been performed within 1 week before the first administration;\n16. Received the vaccine within 30 days before the first administration;\n17. Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 4 weeks prior to the first administration;\n18. For any significant clinical and laboratory abnormalities, the researchers believe that they will affect the safety evaluators, such as: active infection requiring systemic Sex therapy, uncontrollable diabetes, hypertension patients who cannot fall to the normal range (systolic pressure\\>140mmHg, diastolic pressure\\>90mmHg), myocardial infarction within 6 months, thyroid dysfunction (\\>NCI CTCAE v4.0 Level 1 standard) after treatment with two or less antihypertensive drugs;\n19. Researchers believe that it is not suitable for inclusion in the study.",{"count":86,"type":20},25,[88,23],"PHASE1","The Purpose of This Study is to Evaluate the Efficacy and Safety of Gemox combined with Anlotinib and Sintilimab as first-lineTherapy for Patients With advanced combined hepatocellular-cholangiocarcinoma.",[91],"Combined Hepatocellular Cholangiocarcinoma","2023-09-10",{"date":94,"type":42},"2023-09-13",{"date":96,"type":20},"2023-10-01",{"date":98,"type":20},"2026-08-01",{"name":100,"class":49},"Sichuan University"]