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

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