CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Lenvatinib +1 moredrug
Likely dose
Tislelizumab 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04401800
NCT04401800Phase 2Completed
CompareCT.gov

A Phase 2 Study to Investigate the Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib in Patients With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma

BeiGene·interventional·Posted May 26, 2020·Updated Mar 10, 2025

In Brief

A Phase 2 clinical trial evaluating Lenvatinib and Tislelizumab for Hepatocellular Carcinoma and 2 related conditions. Completed, enrolled 64 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 26, 2020
Enrollment StartSep 4, 2020
Primary CompletionDec 1, 2022
Study CompletionFeb 18, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.1 years ago

Interventions

Lenvatinibdrug

Capsules administered orally once daily

Tislelizumabdrug

200 mg intravenous (IV) infusion administered on Day 1 of each cycle