SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

March 31, 2023

Primary Completion Date

February 28, 2027

Study Completion Date

February 28, 2027

Conditions
Advanced Hepatocellular Carcinoma
Interventions
DRUG

Lenvatinib

Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients \<60kg, and 12 mg qd for patients ≥ 60kg)

PROCEDURE

TACE

TACE will be performed one day after oral administration of lenvatinib. Either cTACE or DEB-TACE can be used, depending on the condition of each center.

RADIATION

SBRT

SBRT will be given within 3 weeks after the first TACE with linear accelerator-based photon beams. Gross tumor volume is defined as intrahepatic tumor and vascular invasion including a 1-cm margin into the contiguous HCC. Prescription dose will be 4500-5000 cGy in 5-8 fractions.

Trial Locations (1)

510080

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou

All Listed Sponsors
lead

Sun Yat-sen University

OTHER

NCT05718232 - SBRT Plus Lenvatinib and TACE for Advanced Primary HCC: A Phase 3 Trial (SEARCH) | Biotech Hunter | Biotech Hunter