Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment
A Prospective, Non-interventional Study of Different First-line Immunotherapy in Advanced Hepatocellular Carcinoma Patients: Efficacy and Immune Microenvironment Dynamics
Fudan University
150 participants
Sep 1, 2025
OBSERVATIONAL
Conditions
Summary
To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.
Eligibility
Inclusion Criteria12
- 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 Criteria7
- Prior systemic therapy for HCC
- Active autoimmune disease requiring immunosuppression.
- Active infection requiring IV antibiotics.
- HIV-positive or active HBV/HCV infection (HBsAg+ with HBV DNA ≥2000 IU/mL; HCV RNA+).
- Symptomatic CNS metastases.
- Pregnancy/lactation.
- Any condition compromising protocol compliance or data interpretation per investigator.
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Interventions
Sintilimab will be administered by IV, 200 mg every 3 weeks
Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.
Camrelizumab will be administered by IV, 200 mg every 2 weeks.
Rivoceranib will be administered by oral 250 mg once daily.
Nivolumab will be administered by IV, 1 mg/kg every 3 weeks for up to four doses, followed by nivolumab 480 mg every 4 weeks
Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07147101