Study on Therapeutic Effect of Combination of Envafolimab, Lenavatinib and TACE in Advanced HCC Patients

Summary

This study is a single-center, open, single-arm, phase II clinical trial. Eligible HCC patients, after signing informed consent, will receive TACE treatment. Envafolimab combined with Lenvatinib will be started on the day of TACE, and the subsequent TACE will be performed on demand. Patients will receive the treatment continuously until disease progression or intolerance. Tumor imaging evaluation will be performed according to RECIST V1.1 criteria every 6 weeks. Safety will be assessed with CTCAE 5.0. Adverse events throughout and within 30 days of the end of the study will be recorded (severe adverse events or adverse events associated with Envafolimab will be recorded within 90 days after the end of treatment).Treatment will last for 2 years or until disease progression, withdrawal of informed consent, loss of visit, or death.

Timeline

Start

2022-03-14

Primary completion

2022-09-01

Completion

2023-06-01

Publications

• Chen Y, Zhang J, Hu W, Li X, Sun K, Shen Y, Zhang M, Wu J, Gao S, Yu J, Que R, Zhang Y, Yang F, Xia W, Zhang A, Tang X, Bai X, Liang T. Envafolimab plus lenvatinib and transcatheter arterial chemoembolization for unresectable hepatocellular carcinoma: a prospective, single-arm, phase II study. Signal Transduct Target Ther. 2024 Oct 9;9(1):280. doi: 10.1038/s41392-024-01991-1.

Drugs

Indications