Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma

Summary

The primary objective of this study was to assess the preliminary antitumor activity as indicated by overall response rate (ORR) of tislelizumab in combination with lenvatinib in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) by central site imaging facility per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Timeline

Start

2020-09-04

Primary completion

2022-12-01

Completion

2024-02-18

Outcome

Met primary endpoint

paper The study achieved statistical superiority (p = 0.0003) with 23 responders assessed by IRC per RECIST v1.1 PMID 38650037 ↗

registry analysis (superiority test); Lenvatinib With Tislelizumab; p = 0.0002; Binomial exact test NCT04401800 ↗

Publications

• Xu L, Chen J, Liu C, Song X, Zhang Y, Zhao H, Yan S, Jia W, Wu Z, Guo Y, Yang J, Gong W, Ma Y, Yang X, Gao Z, Zhang N, Zheng X, Li M, Su D, Chen M. Efficacy and safety of tislelizumab plus lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma: a multicenter, single-arm, phase 2 trial. BMC Med. 2024 Apr 23;22(1):172. doi: 10.1186/s12916-024-03356-5.

Drugs

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

Indications