TACE Combined With Lenvatinib and Sintilimab for Advanced HCC

Phase 2 Completed 30 enrolled Second Affiliated Hospital of Guangzhou Medical University

NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) combined with lenvatinib and sintilimab in patients with unresectable advanced hepatocellullar carcinoma (HCC).

Timeline

Start: 2020-10-01
Primary completion: 2021-11-29
Completion: 2022-10-31

Outcome

Met primary endpoint

paper The primary endpoint was met with a median PFS of 8.0 (95% confidence interval [CI]: 6.1-9.8) months per mRECIST PMID 38291865 ↗

Publications

Cai M, Huang W, Liang W, Guo Y, Liang L, Lin L, Xie L, Zhou J, Chen Y, Cao B, Wu J, Zhu K. Lenvatinib, sintilimab plus transarterial chemoembolization for advanced stage hepatocellular carcinoma: A phase II study. Liver Int. 2024 Apr;44(4):920-930. doi: 10.1111/liv.15831. Epub 2024 Jan 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenvatinib	Small molecule	8 mg	Oral
Subject	Lenvatinib	Small molecule	12 mg	Oral
Subject	Sintilimab	Monoclonal antibody	200 mg	Intravenous