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

NCT07147101 | Recruiting

• 1 other identifier: HCC-IM-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  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.

  max 24 months

Secondary Outcomes (7)

• Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 42 months

Study Arms (3)

HCC cohort 1: Sintilimab plus bevacizumab biosimilar

Drug: Sintilimab; Drug: Bevacizumab Biosimilar

HCC cohort 2: Camrelizumab plus Rivoceranib

Drug: Camrelizumab; Drug: Rivoceranib

HCC cohort 3: O+Y

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Sintilimab DRUG

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

HCC cohort 1: Sintilimab plus bevacizumab biosimilar

Bevacizumab Biosimilar DRUG

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

HCC cohort 1: Sintilimab plus bevacizumab biosimilar

Camrelizumab DRUG

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

HCC cohort 2: Camrelizumab plus Rivoceranib

Rivoceranib DRUG

Rivoceranib will be administered by oral 250 mg once daily.

HCC cohort 2: Camrelizumab plus Rivoceranib

Nivolumab 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

HCC cohort 3: O+Y

Ipilimumab DRUG

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

HCC cohort 3: O+Y

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced hepatocellular carcinoma planed to receive first-line immunotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

A baseline tumor biopsy and blood collection before initiation of treatment, followed by a second tumor biopsy with paired blood collection after the first response evaluation will be planned.

MeSH Terms

Interventions

sintilimab; camrelizumab; apatinib; Nivolumab; Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Peng Wang, MD

CONTACT

86-21-64041990; peng_wang@fudan.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)