A Study to Evaluate the Efficacy and Safety of IBI310 and Sintilimab Combination Therapy in Patients With Hepatocellular Carcinoma as First-line Treatment.

Sponsor
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Study ID
NCT07490262
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — BIOLOGICAL
    15 mg/kg intravenous infusion, administered on Day 1 of each 3-week treatment cycle
  • Capecitabine — DRUG
    1000 mg/m² orally, administered on Days 1-14 of each 3-week treatment cycle, maximum 4 cycles.
  • Oxaliplatin — DRUG
    85 mg/m² intravenous infusion, administered on Day 1 of each 3-week treatment cycle, maximum 4 cycles.
  • IBI310 — BIOLOGICAL
    1 mg/kg intravenous infusion, administered on Day 1 of each 6-week treatment cycle
  • Sintilimab — BIOLOGICAL
    200 mg intravenous infusion, administered on Day 1 of each 3-week treatment cycle

Study Details

This study is a randomized, controlled, open-label, multicenter, seamless Phase II/III trial designed to evaluate the efficacy and safety of the combination regimen of IBI310 and sintilimab in participants with locally advanced or metastatic hepatocellular carcinoma (HCC) who are: (1) treatment-naive to systemic therapy; and (2) either unsuitable for curative-intent surgical resection or local therapy, or have experienced disease progression following prior surgical resection or local therapy.

Key Dates

Start date
Mar 27, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
680 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control Group
    Sintilimab+ Bevacizumab
  • Experimental: Treatment Group2
    Sintilimab+ IBI310+Bevacizumab
  • Experimental: Treatment Group3
    Sintilimab+ IBI310+Oxaliplatin+Capecitabine
  • Experimental: Treatment Group1
    Sintilimab+ IBI310+Bevacizumab+Oxaliplatin+Capecitabine

Primary Outcome Measure

Phase II: ORR （Objective Response Rate） assessed by investigator per RECIST 1.1. [ Time Frame: up to 2 years ]

Central Contacts

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