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

NCT ID: NCT07147101

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-01

Brief Summary

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

Detailed Description

This is a prospective, non-interventional, observational study evaluating the efficacy and immune microenvironment changes in advanced hepatocellular carcinoma (HCC) patients receiving different first-line immunotherapy, including anti-PD1+anti-VEGF, anti-PD1+TKI and anti-PD1+anti-CTLA4. The primary endpoint is objective response rate (ORR), with secondary endpoints including disease control rate (DCR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and immune profiling of tumor tissue and peripheral blood before and after treatment.

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HCC cohort 1: Sintilimab plus bevacizumab biosimilar

Sintilimab

Intervention Type: DRUG

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

Bevacizumab Biosimilar

Intervention Type: DRUG

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

HCC cohort 2: Camrelizumab plus Rivoceranib

Camrelizumab

Intervention Type: DRUG

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

Rivoceranib

Intervention Type: DRUG

Rivoceranib will be administered by oral 250 mg once daily.

HCC cohort 3: O+Y

Nivolumab

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Interventions

Sintilimab

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

Intervention Type: DRUG

Bevacizumab Biosimilar

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

Intervention Type: DRUG

Camrelizumab

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

Intervention Type: DRUG

Rivoceranib

Rivoceranib will be administered by oral 250 mg once daily.

Intervention Type: DRUG

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

Intervention Type: DRUG

Ipilimumab

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Peng Wang

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Peng Wang, MD

Role: CONTACT

peng_wang@fudan.edu.cn

86-21-64041990

Facility Contacts

Peng MD, Wang

Role: primary

peng_wang@fudan.edu.cn

+86021-64041990

Other Identifiers

HCC-IM-1

Identifier Type: -

Identifier Source: org_study_id