RecruitingPhase 2NCT06860490

HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

Sintilimab Plus Bevacizumab Biosimilar With or Without HAIC for Advanced Hepatocellular Carcinoma (TASK-03): a Multicenter, Randomized, Phase 2 Study


Sponsor

Fudan University

Enrollment

164 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of hepatic arterial infusion chemotherapy (HAIC — high-dose chemo delivered directly to the liver), sintilimab (an immunotherapy), and bevacizumab biosimilar (a drug that blocks tumor blood vessel growth) in patients with advanced liver cancer (hepatocellular carcinoma, HCC) who have not yet received systemic treatment. **You may be eligible if...** - You are 18 or older - You have confirmed HCC at an advanced (Barcelona Stage C) or intermediate (Stage B) stage not eligible for surgery or local treatment - You have not received any prior systemic therapy for liver cancer - You have at least one measurable tumor, adequate liver function (Child-Pugh score 5–7), and ECOG performance status 0–2 - If you have hepatitis B, your viral load is below 100 IU/mL and you are on antiviral therapy **You may NOT be eligible if...** - You are on a liver transplant waiting list or have advanced liver disease - You have had a stroke, serious blood clot, or pulmonary embolism in the past 6 months - You have received prior systemic, endocrine, or immune therapy for HCC - You have previously been treated with HAIC 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

DRUGSintilimab

Sintilimab will be administered by IV, 200 mg on day 1 of each 21 day cycle.

DRUGBevacizumab Biosimilar

Bevacizumab biosimilar will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle.

PROCEDUREHAIC

FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 3 weeks for up to four cycles. Sintilimab plus bevacizumab will be administered 1-3 days after HAIC.


Locations(1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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NCT06860490


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