Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT07543783
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Adebrelimab (SHR-1316)
  • Bevacizumab
  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Transarterial Chemoembolization (TACE) — PROCEDURE
    Transarterial chemoembolization performed as first-line intervention for unresectable hepatocellular carcinoma.
  • Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX) — DRUG
    Hepatic arterial infusion chemotherapy with FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours).
  • Adebrelimab — DRUG
    Intravenous adebrelimab 1200 mg fixed dose, administered every 3 weeks (Q3W).
  • Low-dose Bevacizumab — DRUG
    Intravenous bevacizumab 7.5 mg/kg, administered every 3 weeks (Q3W).

Study Details

his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg/kg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.

Key Dates

First listed
Apr 22, 2026
Start date
Apr 10, 2026
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TACE-HAIC + Adebrelimab + Low-dose Bevacizumab
    Participants with unresectable hepatocellular carcinoma (HCC) receive first-line treatment with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) using the FOLFOX regimen (oxaliplatin 85 mg/m², leucovorin 400 mg/m², fluorouracil 400 mg/m² bolus then 2400 mg/m² continuous infusion over 24 hours), administered via hepatic artery catheter. Subsequently, participants receive intravenous adebrelimab (1200 mg fixed dose, Q3W) and low-dose bevacizumab (7.5 mg/kg, Q3W). Each treatment cycle is 21 days. Treatment continues until disease progression (RECIST v1.1), unacceptable toxicity, patient withdrawal, conversion to resectable disease, or investigator decision. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 36 months from the first dose of study treatment ]

Central Contacts

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