Different First-line Immunotherapy for Advancer Hepatocellular Carcinoma: A Prospective Observational Study on Efficacy and Immune Microenvironment (HCC-IM-1)

Fudan University

Status: Not yet enrolling

Conditions: Advanced Hepatocellular Carcinoma (HCC)

Treatments: Drug: Rivoceranib; Drug: Sintilimab; Drug: Camrelizumab; Drug: Nivolumab; Drug: Bevacizumab Biosimilar; Drug: Ipilimumab

Study type: Observational

Funder types: Other

Identifiers

NCT07147101

HCC-IM-1

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

150 participants in 3 patient groups

HCC cohort 1: Sintilimab plus bevacizumab biosimilar

Treatment:

Drug: Bevacizumab Biosimilar

Drug: Sintilimab

HCC cohort 2: Camrelizumab plus Rivoceranib

Treatment:

Drug: Camrelizumab

Drug: Rivoceranib

HCC cohort 3: O+Y

Treatment:

Drug: Ipilimumab

Drug: Nivolumab