RecruitingPhase 2NCT06737913

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

Hepatic Arterial Infusion or Intravenous Infusion of Adebrelimab, Combined With Bevacizumab and Hepatic Arterial Infusion of FOLFOX Chemotherapy for Advanced Hepatocellular Carcinoma: a Multicenter, Open Label, Randomized Phase II Trial

Sponsor

Sun Yat-sen University

Enrollment

76 participants

Start Date

Jan 3, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Hepatocellular Carcinoma (HCC)

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination treatment for advanced liver cancer (hepatocellular carcinoma) that cannot be removed by surgery. It combines a drug delivered directly into the liver's blood supply with immunotherapy (adebrelimab) and a targeted drug (bevacizumab) to see if this approach works better than existing options. **You may be eligible if...** - You are 18 or older and have been diagnosed with liver cancer - Your cancer is at an advanced stage with blood vessel involvement or spread to other organs - You have not previously received systemic (whole-body) treatment for this liver cancer, or your disease progressed after prior treatment - Your liver function is reasonably preserved **You may NOT be eligible if...** - You have already had systemic chemotherapy or targeted therapy for liver cancer - You have a severe form of blood vessel tumor clot (Vp4-type) - Your liver function is severely impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHAI Adebrelimab

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

DRUGintravenous infusion (IV) of Adebrelimab (ADE)

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

DRUGintravenous infusion (IV) of Bevacizumab (Bev.)

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

PROCEDUREHAIC 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)

DRUGAdebrelimab 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