The Safety and Efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody of Advanced Unresectable Hepatocellular Carcinoma

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

142

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

May 24, 2022

Study Completion Date

January 31, 2024

Conditions
Hepatocellular Carcinoma Non-resectableTransarterial ChemoembolizationTyrosine Kinase InhibitorImmune Checkpoint Blockade
Interventions
DRUG

lenvatinib + sindilimab/carrelizumab

4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next treatment cycle was carried out. The trial was terminated if the drug was stopped for more than 28 days due to adverse drug reactions or other reasons. Patients with PD after 6 cycles of sindilimab/carrelizumab treatment were terminated. The follow-up treatment was based on the principle of individualization, multidisciplinary discussion and patients' willingness.

PROCEDURE

TACE

"TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2018 Edition).~The patients with HCC were selected according to the inclusion criteria (referring to the conditions of the subjects). The subjects who met the inclusion criteria could enter the study after they signed the informed consent. 4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next cycle of TACE treatment was carried out. The general principle is to reduce the number of interventional treatment and extend the interval of interventional operation as far as possible under the condition of controlling the tumor and the survival of patients with tumor."

Trial Locations (1)

610041

West China Hospital of Sichuan University, Chengdu

All Listed Sponsors
lead

Xinrui Zhu,MD

OTHER

NCT04997850 - The Safety and Efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody of Advanced Unresectable Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter