NCT05985798

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a multicenter, prospective and randomized controlled trial to evaluate the efficacy and safety of Sin-Bev-TACE versus Len-TACE for patient with advanced HCC. 258 patients with advanced HCC (BCLC C stage) will be enrolled in this study. The patients will receive either sintilimab and bevacizumab (Sin-Bev) or lenvatinib (Len) after first TACE using an 1:1 randomization scheme. In the Sin-Bev-TACE arm, sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) will be started at 3-7 days after the first TACE. In the the Len-TACE arm, 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 based on the evaluation of follow-up laboratory and imaging examination. Sintilimab and bevacizumab will last up to 24 months, or until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Lenvatinib will last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. In the Sin-Bev-TACE arm, patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity. The primary end point of this study is overall survival (OS). The secondary endpoints are progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs).

Conditions

• Hepatocellular Carcinoma Non-resectable

Interventions

Type	Name	Description
DRUG	Sin-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.
DRUG	Len-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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: China