Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Ob
To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.
| Condition(s) | Advanced Hepatocellular Carcinoma (HCC) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy. |
| Who can participate | Inclusion Criteria: * Age ≥ 18 years at time of study entry. * Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies. * HCC confirmed by radiology, histology or cytology. * No prior systemic therapy for HCC. * At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI. * Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale). * Adequate organ function: * ANC ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL. * Total bilirubin ≤1.5 × ULN, AST/ALT ≤3 × ULN (≤5 × ULN if liver metastases). * Creatinine ≤1.5 × ULN or CrCl ≥60 mL/min. * Willing to provide archival/fresh tumor tissue and peripheral blood samples. * Signed informed consent. Exclusion Criteria: * Prior systemic therapy for HCC * Ac |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2025-09-01 |
| NCT ID | NCT07147101 |
| Official listing | https://clinicaltrials.gov/study/NCT07147101 |