HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

Sponsor
Fudan University
Study ID
NCT06860490
Phase
PHASE2
Status
Recruiting
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Conditions

  • 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 on day 1 of each 21 day cycle.
  • Bevacizumab Biosimilar — DRUG
    Bevacizumab biosimilar will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle.
  • HAIC — PROCEDURE
    FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 3 weeks for up to four cycles. Sintilimab plus bevacizumab will be administered 1-3 days after HAIC.

Study Details

To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.

Key Dates

First listed
Mar 6, 2025
Start date
Mar 18, 2025
Status verified
Apr 2026
Primary completion
Mar 10, 2027
Completion
Mar 10, 2028

Study Design

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

Arms

  • Experimental: HAIC+sintilimab+bevacizumab
    HAIC in combination with Sintilimab plus bevacizumab biosimilar
  • Active Comparator: Sintilimab+bevacizumab
    Sintilimab plus bevacizumab biosimilar

Primary Outcome Measure

Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 [ Time Frame: max 24 months ]

Central Contacts

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