drugset / Trial / NCT04997850

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

NCT04997850

Phase 1/2 Completed 142 enrolled Xinrui Zhu,MD
Non-randomizedParallel-groupOpen-labelTreatment

Summary

We adopted the prospective cohort study to compare the safety and efficacy of Transarterial Chemoembolization (TACE) + Lenvatinib + Programmed Cell Death Protein 1 (PD-1) Antibody in the treatment of advanced unresectable liver cancer.The purposes of our study include:1. Primary objective: To compare the safety and efficacy of TACE combined with Lenvatinib and PD-1 antibody versus TACE alone in the conversion-resection of patients with advanced unresectable hepatocellular carcinoma.2. Secondary objective: To compare the long-term outcome of TACE combined with Lenvatinib and PD-1 antibody versus TACE alone for patients with advanced unresectable hepatocellular carcinoma.

Timeline

Start
2020-10-01
Primary completion
2022-05-24
Completion
2024-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Camrelizumab Monoclonal antibody 200 mg Intravenous
Subject Lenvatinib Small molecule 8 mg Oral
Subject Lenvatinib Small molecule 12 mg Oral
Subject Sindilimab Unknown 200 mg Intravenous