MedTrace Logo

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

NCT07543783 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2026-04-28

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

PROCEDURE

Transarterial Chemoembolization (TACE)

Transarterial chemoembolization performed as first-line intervention for unresectable hepatocellular carcinoma.

DRUG

Hepatic Arterial Infusion Chemotherapy (HAIC, FOLFOX)

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).

DRUG

Adebrelimab

Intravenous adebrelimab 1200 mg fixed dose, administered every 3 weeks (Q3W).

DRUG

Low-dose Bevacizumab

Intravenous bevacizumab 7.5 mg/kg, administered every 3 weeks (Q3W).

Sponsors & Collaborators

  • Shanghai Shengdi Pharmaceutical Co., Ltd

    collaborator INDUSTRY

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2029-08-31
Completion
2029-08-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07543783 on ClinicalTrials.gov