TACE/HAIC Combined With Lenvatinib and Sintilimab in Neoadjuvant Therapy for Intermediate-stage HCC

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

December 30, 2023

Study Completion Date

December 30, 2024

Conditions
Hepatocellular Carcinoma
Interventions
PROCEDURE

TACE/HAIC

Within 1-3 days of lenvatinib and sintilimab, start Transarterial chemobolization treatment or FOLFOX-based chemotherapy infusion,after three months,patients who achieved partial response (PR) or minor response (MR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and were assessed as eligible for R0 resection go on to undergo surgical resection.

DRUG

Lenvatinib

Participants received lenvatinib capsules 8mg for patients weight \<60kg, or 12mg for patients weight more than 60Kg.

DRUG

Sintilimab

Sintilimab Injection will be administered every three weeks (200mg) until surgery or disease progression.

PROCEDURE

liver resection

liver resection is feasible after evaluation by the liver cancer surgery expert group

Trial Locations (1)

510630

RECRUITING

Third Affiliated Hospital, Sun Yat-Sen University, Guangzhou

All Listed Sponsors
lead

Third Affiliated Hospital, Sun Yat-Sen University

OTHER