[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617111":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":45,"responsibleParty":64,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":98,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"F1\u002FF2 Subtype: Camrelizumab Plus Apatinib","EXPERIMENTAL","Participants whose tumors are classified as F1 or F2 based on the fatty acid degradation (FAD) subtype will receive systemic therapy with camrelizumab and apatinib. Camrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the planned treatment duration. Imaging assessments are conducted every 6 weeks to evaluate tumor response.",[13],"Drug: Camrelizumab Plus Apatinib",{"label":15,"type":10,"description":16,"interventionNames":17},"F3 Subtype: TACE Plus Camrelizumab and Apatinib","Participants with the F3 metabolic subtype, characterized by high fatty acid degradation activity, will receive transarterial chemoembolization (TACE) in addition to systemic therapy. Camrelizumab (200 mg IV every 3 weeks) and apatinib (250 mg orally once daily) are administered on the same schedule as the F1\u002FF2 arm. TACE is performed 2-4 weeks after systemic therapy initiation, with up to two treatments per tumor (maximum four sessions total). Apatinib is paused 3-5 days before TACE and restarted 3-5 days afterward. Treatment continues until disease progression, unacceptable toxicity, or discontinuation for clinical reasons. Imaging assessments occur every 6 weeks.",[18],"Drug: TACE Plus Camrelizumab and Apatinib",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Camrelizumab Plus Apatinib","Camrelizumab is administered intravenously at 200 mg every 3 weeks, and apatinib is taken orally at 250 mg once daily.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"TACE Plus Camrelizumab and Apatinib","Camrelizumab (200 mg IV every 3 weeks) and apatinib (250 mg orally once daily) are administered on the same schedule as the F1\u002FF2 arm. TACE is performed 2-4 weeks after systemic therapy initiation, with up to two treatments per tumor (maximum four sessions total). Apatinib is paused 3-5 days before TACE and restarted 3-5 days afterward.",[15],[31],{"name":32,"affiliation":33,"role":34},"Decai Yu, Doctor","the Affiliated Drum Tower Hospital, Medical School of Nanjing University","STUDY_CHAIR",[36,41],{"name":32,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","+86-025-68182222","60911","yudecai@nju.edu.cn",{"name":42,"role":37,"phone":43,"phoneExt":25,"email":44},"Yuan Cheng, Doctor","+8613915963713","19656093@qq.com",[46],{"facility":47,"status":25,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School","Nanjing","Jiangsu","210008","China","CN",{"type":54,"coordinates":55},"Point",[56,57],118.77778,32.06167,{"lat":57,"lon":56},[60],{"name":61,"role":37,"phone":62,"phoneExt":25,"email":63},"Decai Yu","+8615996257605","lbhnju@163.com",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","YU DE CAI","Professor","100617111","phase-2-fad-subtype-guided-combination-therapy-for-unresectable-hepatocellular-carcinoma-100617111",false,"NCT07314372","FAD Subtype-Guided Combination Therapy for Unresectable Hepatocellular Carcinoma","A Prospective Phase II Study of Fatty Acid Degradation (FAD) Subtype-Guided Comprehensive Therapy for Unresectable Hepatocellular Carcinoma","FAD-HCC-001","Inclusion Criteria:\n\n1. Adults ≥18 years of age who voluntarily agree to participate and sign informed consent.\n2. Histologically or cytologically confirmed hepatocellular carcinoma (HCC).\n3. Unresectable or not suitable for curative local therapy, or progression after prior surgery or local therapy.\n4. BCLC stage B or C.\n5. No prior systemic therapy for HCC.\n6. At least one measurable lesion according to RECIST v1.1.\n7. Availability of fresh or archival tumor tissue for FAD subtype testing; if not available at screening, MRI fat fraction may be used temporarily.\n8. Child-Pugh class A or B (≤7 points).\n9. ECOG performance status 0-1.\n10. Adequate organ function, including:\n\n    * ANC ≥1.5 × 10⁹\u002FL\n    * Platelets ≥75 × 10⁹\u002FL\n    * Hemoglobin ≥90 g\u002FL\n    * Albumin ≥30 g\u002FL\n    * Total bilirubin ≤1.5 × ULN\n    * ALT and AST ≤3 × ULN\n    * Serum creatinine ≤1.5 × ULN or creatinine clearance \\>50 mL\u002Fmin\n    * INR ≤1.2 or PT within 2 seconds above ULN\n    * Urine protein \\\u003C2+ or 24-hour urine protein \\\u003C1.0 g\n11. Controlled HBV infection (HBV-DNA \\\u003C2000 IU\u002FmL; if above this level, ≥1 week of antiviral therapy with ≥1-log reduction prior to first dose). HCV-positive individuals must be managed per clinical guidelines.\n12. Life expectancy ≥12 weeks.\n13. Women of childbearing potential must have a negative pregnancy test; participants of reproductive potential must agree to effective contraception during treatment and for 6 months afterward.\n\nExclusion Criteria:\n\n1. Non-HCC primary liver cancers (e.g., cholangiocarcinoma, combined HCC-CCA).\n2. F3 subtype without liver lesions on imaging.\n3. Clinically significant ascites requiring therapeutic intervention, or uncontrolled pleural\u002Fpericardial effusion.\n4. Interstitial lung disease, pneumonitis requiring steroids, or active pulmonary infection.\n5. Active or history of autoimmune disease requiring systemic treatment (exceptions allowed per protocol, e.g., controlled hypothyroidism).\n6. Recent use (within 2 weeks) of systemic immunosuppressive therapy \\>10 mg\u002Fday prednisone equivalent.\n7. Gastrointestinal bleeding within 6 months, high-risk varices, active ulcers, fistula, perforation, or intra-abdominal abscess.\n8. Known bleeding or clotting disorders; therapeutic anticoagulation not permitted.\n9. Thromboembolic events within 6 months (e.g., stroke, PE).\n10. Significant cardiovascular disease, including NYHA class ≥II heart failure, recent MI (within 1 year), unstable angina, clinically significant arrhythmias, or QTc prolongation.\n11. Uncontrolled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite treatment), or history of hypertensive crisis.\n12. Major vascular disease within 6 months (e.g., arterial thrombosis, aneurysm requiring repair).\n13. Serious non-healing wounds, active ulcers, or fractures.\n14. Inability to swallow oral medication or conditions affecting drug absorption.\n15. Severe infection within 4 weeks, therapeutic antibiotics within 14 days, fever ≥38.5°C within 7 days before enrollment, or WBC \\>15 × 10⁹\u002FL.\n16. Known HIV infection or other causes of immunodeficiency.\n17. Receipt of live attenuated vaccines within 28 days before treatment.\n18. Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results, including substance abuse, severe psychiatric illness, or social factors.","ALL","18 Years",{"count":79,"type":80},86,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","This study is a prospective, multicenter Phase II trial evaluating a personalized treatment strategy for patients with unresectable hepatocellular carcinoma (HCC). The study uses a metabolic classification system called the fatty acid degradation (FAD) subtype to guide therapy selection. Patients will be assigned to different treatment groups based on their tumor's FAD subtype, determined through RNA-seq analysis of the tumor tissue obtained from liver biopsy.",[86,87,88],"Unresectable Hepatocellular Carcinoma (HCC)","Hepatocellular Carcinoma (HCC)","Liver Cancer Adult",[90,91,92,93,94,95,96,97],"Hepatocellular Carcinoma","Fatty Acid Degradation","Metabolic Subtyping","Precision Medicine","Conversion Therapy","Immunotherapy","Anti-angiogenic Therapy","TACE","NOT_YET_RECRUITING","2026-01-16",{"date":101,"type":102},"2026-01-20","ACTUAL",{"date":104,"type":80},"2026-02-01",{"date":106,"type":80},"2028-12",{"name":5,"class":6},1]