[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653495":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":17,"studyPopulation":21,"armGroups":22,"interventions":33,"overallOfficials":44,"centralContacts":49,"locations":17,"responsibleParty":59,"collaborators":17,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":17,"enrollmentInfo":72,"targetDuration":17,"studyType":75,"phases":17,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":86,"whyStopped":17,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":17},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":17},[9,13],{"measure":10,"description":11,"timeFrame":12},"Objective Response Rate (ORR) Assessed by RECIST v1.1 and HCC mRECIST Criteria","The ORR will be evaluated according to RECIST v1.1 and HCC mRECIST criteria, defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.defined as the sum of complete response (CR) and partial response (PR) in patients with at least one measurable lesion.","Up to 2 years (assessed every 8 ± 2 weeks)",{"measure":14,"description":15,"timeFrame":16},"Levels of Predictive Biomarkers Assessed by Multi-Omics Sequencing and Single Cell RNA Sequencing","Identify 3-4 predictive biomarkers for the efficacy of HCC systemic therapy, including genes, proteins, ctDNA, and immune cell subsets based on tumor tissue or peripheral blood.","Up to 2 years",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","The study population consists of patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) confirmed by histology, cytology, or clinical diagnostic criteria. Eligible patients must have an ECOG performance status of 0 to 2 and well-preserved liver function, defined as Child-Pugh class A or a score of 7. The population includes patients who are scheduled to receive standard systemic therapies, such as targeted therapy combined with immunotherapy or dual immunotherapy, either alone or in combination with local therapies like transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC).",[23,28],{"label":24,"type":17,"description":25,"interventionNames":26},"Systemic Therapy Cohort","Patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) receiving systemic therapy alone.",[27],"Drug: Systemic therapy",{"label":29,"type":17,"description":30,"interventionNames":31},"TACE\u002FHAIC + Systemic Therapy Cohort","Patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC) receiving transcatheter arterial chemoembolization (TACE) or hepatic arterial infusion chemotherapy (HAIC) combined with systemic therapy.",[27,32],"Procedure: Local therapy",[34,39],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":17},"DRUG","Systemic therapy","Including regimens such as Atezolizumab + Bevacizumab, Nivolumab + Ipilimumab.",[24,29],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":17},"PROCEDURE","Local therapy","Including therapy such as TACE, HAIC",[29],[45],{"name":46,"affiliation":47,"role":48},"Huichuan Sun, MD","Fudan University","PRINCIPAL_INVESTIGATOR",[50,55],{"name":51,"role":52,"phone":53,"phoneExt":17,"email":54},"Hui Li, MD","CONTACT","+86 64041990","li.hui1@zs-hospital.sh.cn",{"name":56,"role":52,"phone":57,"phoneExt":17,"email":58},"Chengjie ZZ Zhong","18223590185","cjzhong24@m.fudan.edu.cn",{"type":48,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Hui-Chuan Sun","Professor","100653495","biomarker-and-mechanism-study-of-systemic-therapy-in-unresectable-hcc-100653495",false,"NCT07786792","Biomarker and Mechanism Study of Systemic Therapy in Unresectable HCC","Observational Study and Biomarkers and Molecular Mechanism Study of Systemic Therapy for Intermediate to Advanced Stage or Unresectable Hepatocellular Carcinoma","MUSE2","Inclusion Criteria:\n\n* Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or meeting the clinical diagnostic criteria of the \"Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2024 Edition)\" issued by the National Health Commission of China.\n* Assessed by the investigator as unsuitable for surgical resection, or having intermediate to advanced stage HCC. Intermediate to advanced HCC is defined as Barcelona Clinic Liver Cancer (BCLC) stage B\u002FC or China Liver Cancer (CNLC) stage IIa\u002FIIb\u002FIIIa\u002FIIIb.\n* Child-Pugh liver function class A or a score of 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2.\n* Willing to receive targeted therapy combined with immunotherapy or dual immunotherapy, and signed the informed consent form (applicable to the prospective cohort).\n* Adequate bone marrow and organ function, meeting the following laboratory indicators: Absolute neutrophil count (ANC) \\>= 1.0x10\\^9\u002FL without the use of granulocyte colony-stimulating factor within the past 14 days; Platelets \\>= 50x10\\^9\u002FL without blood transfusion within the past 14 days; Hemoglobin \\>= 90g\u002FL without blood transfusion or erythropoietin use within the past 14 days; Total bilirubin \\\u003C= 3 x upper limit of normal (ULN); Albumin \\>= 28g\u002FL without human serum albumin or plasma infusion within the past 14 days; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C= 5 x ULN; Serum creatinine \\\u003C= 1.5 x ULN; Good coagulation function, defined as an international normalized ratio (INR) of prothrombin time \\\u003C= 1.5 x ULN.\n* Subjects at risk of pregnancy (male or female) must use a contraceptive method with an annual failure rate of less than 1% during the entire treatment period and until 120 days after the last dose of the study drug (or 180 days after the last dose of chemotherapy drugs).\n\nExclusion Criteria:\n\n* Pathological diagnosis of mixed liver cancer, fibrolamellar hepatocellular carcinoma, or other non-hepatocellular malignant tumor components.\n* Previous or concurrent other malignant tumors, except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.\n* History of organ transplantation or hepatic encephalopathy. Known allergy to the selected targeted therapy drugs or immunotherapy drugs or drug excipients, or previous severe allergic reactions to other monoclonal antibodies.\n* History of gastrointestinal perforation and\u002For fistula within the past 6 months, history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive intestinal resection (partial colon resection or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, or long-term chronic diarrhea.\n* Active autoimmune disease requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose (replacement therapies like thyroxine, insulin, or physiologic corticosteroids for adrenal\u002Fpituitary insufficiency are allowed).\n* Known history of primary immunodeficiency disease. Uncontrolled hypertension (systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg after optimal medical treatment), history of hypertensive crisis, or hypertensive encephalopathy.\n* History of esophageal or gastric variceal bleeding events caused by portal hypertension within the past 6 months.\n* Diagnosed with severe (G3) varices by digestive endoscopy within 3 months prior to the first dose, or assessed by the investigator as having a high risk of bleeding. Subjects requiring withdrawal of informed consent.\n* Other conditions considered unsuitable by the investigator for participation in this clinical trial.","ALL","18 Years",{"count":73,"type":74},400,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the safety and efficacy of systemic therapies and identify predictive molecular biomarkers in patients with intermediate to advanced stage or unresectable hepatocellular carcinoma (HCC).\n\nThe main questions it aims to answer are:What is the objective response rate (ORR) of systemic therapy regimens in this patient population? Which 3-4 specific biomarkers (including tumor or peripheral blood-derived genes, proteins, ctDNA, and immune cell subsets) can reliably predict the efficacy of systemic treatment?",[78],"Hepatocellular Carcinoma",[78,80,81,82,83,84,85],"Immunotherapy","Systemic Therapy","Biomarker","ctDNA","Observational Study","Multi-omics","NOT_YET_RECRUITING","2026-08-31",{"date":89,"type":90},"2026-09-02","ACTUAL",{"date":92,"type":74},"2026-09-01",{"date":94,"type":74},"2027-01-01",{"name":5,"class":6}]