Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment

NCT07147101 · tracked via the Priya Life Science China tracker

Sponsor

Fudan University

Phase

Observational

Started

2025-09-01

Last updated

2026-04-21

Condition(s) studied

Advanced Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Sintilimab →Bevacizumab Biosimilar →Camrelizumab →Rivoceranib →Nivolumab →Ipilimumab →

Sintilimab: Sintilimab will be administered by IV, 200 mg every 3 weeks

Bevacizumab Biosimilar: Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.

Camrelizumab: Camrelizumab will be administered by IV, 200 mg every 2 weeks.

Rivoceranib: Rivoceranib will be administered by oral 250 mg once daily.

Nivolumab: 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: Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.

Study summary

To evaluate the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 * 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.

Primary outcome measure(s)

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 — max 24 months
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters). Responses are according to RECIST 1.1 as assessed by investigator.

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting

On this site

📄 Opdivo (nivolumab) drug profile →

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HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07147101 on ClinicalTrials.gov ↗ ← All trials in China