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

PHASE3RecruitingINTERVENTIONAL
Enrollment

427

Participants

Timeline

Start Date

November 2, 2022

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Hepatocellular Carcinoma Non-resectable
Interventions
DRUG

Lenvatinib, sintilimab plus TACE

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd and sintilimab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.

DRUG

Lenvatinib plus 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 if clinically indicated. The interruption, dose reduction and discontinuation of lenvatinib depended on the presence and severity of toxicities according to the drug directions.

Trial Locations (1)

510260

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou

All Listed Sponsors
lead

Second Affiliated Hospital of Guangzhou Medical University

OTHER