RecruitingPhase 3NCT05985798

Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC

Sintilimab, Bevacizumab Plus TACE Versus Lenvatinib Plus TACE for Advanced Stage Hepatocellular Carcinoma: A Randomized Controlled Trial

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

258 participants

Start Date

Aug 1, 2023

Study Type

INTERVENTIONAL

Conditions

Hepatocellular Carcinoma Non-resectable

Summary

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatment combinations for people with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed. It tests whether adding immunotherapy and a targeted antibody to a procedure called TACE (which delivers chemotherapy directly into liver tumors) works better than a standard drug plus TACE. **You may be eligible if...** - You have been diagnosed with advanced liver cancer (BCLC Stage C) - Your cancer has not been treated with systemic therapy, TACE, or other liver-directed treatments before - Your cancer is suitable for TACE **You may NOT be eligible if...** - You have already received systemic cancer treatment or liver-directed therapy - Your cancer is not suitable for TACE - You have severe liver disease or other major health conditions 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

DRUGSin-Bev-TACE

Sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) are administered at 3-7 days after the first TACE. The study treatment of sintilimab and bevacizumab will last up to 24 months. TACE can be repeated on demand.

DRUGLen-TACE

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand.