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

Sponsor
Fudan University
Study ID
NCT07147101
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sintilimab — DRUG
    Sintilimab will be administered by IV, 200 mg every 3 weeks
  • Bevacizumab Biosimilar — DRUG
    Bevacizumab biosimilar will be administered by IV, 15 mg/kg every 3 weeks.
  • Camrelizumab — DRUG
    Camrelizumab will be administered by IV, 200 mg every 2 weeks.
  • Rivoceranib — DRUG
    Rivoceranib will be administered by oral 250 mg once daily.
  • 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
  • Ipilimumab — DRUG
    Ipilimumab will be administered by IV, 3mg/kg every 3 weeks for up to four doses.

Study Details

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

Key Dates

First listed
Aug 28, 2025
Start date
Sep 1, 2025
Status verified
Aug 2025
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: HCC cohort 1: Sintilimab plus bevacizumab biosimilar
  • Arm: HCC cohort 2: Camrelizumab plus Rivoceranib
  • Arm: HCC cohort 3: O+Y

Primary Outcome Measure

Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: max 24 months ]

Central Contacts