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

NCT06737913 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2026-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Interventions

PROCEDURE

HAI Adebrelimab

Hepatic arterial infusion (HAI) of Adebrelimab (ADE) (1200mg, IA, Q3W)

DRUG

intravenous infusion (IV) of Adebrelimab (ADE)

intravenous infusion (IV) of Adebrelimab (ADE) (1200mg, IV, Q3W)

DRUG

intravenous infusion (IV) of Bevacizumab (Bev.)

intravenous infusion (IV) of Bevacizumab (Bev.) (15mg/kg, IV, Q3W)

PROCEDURE

HAIC with FOLFOX regimen

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)

DRUG

Adebrelimab and bevacizumab maintainance treatment

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

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Fujian Medical University

    collaborator OTHER

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • Cancer Hospital of Guangxi Medical University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-03
Primary Completion
2028-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

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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 NCT06737913 on ClinicalTrials.gov