HAI or IV of Adebrelimab, Combined With Bevacizumab and HAI of FOLFOX for Advanced Unresectable Hepatocellular Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT06737913
Phase
PHASE2
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

  • HAI Adebrelimab — PROCEDURE
    Hepatic arterial infusion (HAI) of Adebrelimab (ADE) (1200mg, IA, Q3W)
  • intravenous infusion (IV) of Adebrelimab (ADE) — DRUG
    intravenous infusion (IV) of Adebrelimab (ADE) (1200mg, IV, Q3W)
  • intravenous infusion (IV) of Bevacizumab (Bev.) — DRUG
    intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W)
  • HAIC with FOLFOX regimen — PROCEDURE
    HAIC with FOLFOX regimen (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil bolus 400 mg/m2 on day 1, and 5-fluorouracil infusion 2500 mg/m2 for 46 hours via hepatic artery Q4W)
  • Adebrelimab and bevacizumab maintainance treatment — DRUG
    The two arms continue the triple combination treatment up to 6 cycles and then received receive intravenous combination therapy of adebrelimab and bevacizumab for maintainance until disease progression or intolerable toxicity

Study Details

The purpose of this study is to evaluate the efficacy and safety of Adabrelimab (arterial or intravenous administration) combined with hepatic artery FOLFOX infusion chemotherapy and Bevacizumab as the first-line treatment of advanced stage hepatocellular carcinoma. Patients will be randomized 1:1 etither to receive hepatic arterial infusion(HAI) Adabrelimab group or IV Adabrelimab group, and both groups will receive HAI FOLFOX chemotherapy and IV Bevacizumab.

Key Dates

First listed
Dec 17, 2024
Start date
Jan 3, 2025
Status verified
Mar 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: HAIBrave-001 Arm 1
    Arm 1 to receive Hepatic arterial infusion (HAI) of Adebrelimab (ADE) + intravenous infusion (IV) of Bevacizumab (Bev.) + Hepatic artery infusion chemotherapy (HAIC) with FOLFOX regimen
  • Experimental: HAIBrave-001 Arm 2
    Intravenous infusion (IV) of Adebrelimab (ADE) + intravenous infusion (IV) of Bevacizumab (Bev.)+ HAIC with FOLFOX regimen

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 6 weeks ]

Central Contacts