drugset / Trial / NCT05564338

Efficacy and Safety of Sitravatinib Plus Tislelizumab or Placebo Plus Tislelizumab Versus Placebo as Adjuvant Treatment in Participants With Hepatocellular Carcinoma

NCT05564338 ↗

Phase 3 Withdrawn BeiGene
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of sitravatinib plus tislelizumab or placebo plus tislelizumab versus placebo. The study will also compare the recurrence-free survival (RFS) in participants with hepatocellular carcinoma (HCC) who are at high risk of recurrence after surgical resection.

Timeline

Start
2023-06-30
Primary completion
2027-04-30
Completion
2028-04-30

Outcome

Outcome not reported

Stopped (Business): “Study has voluntarily discontinued due to a change in the company-level development strategy and is not because of any safety concern or the request from any health authority worldwide.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Sitravatinib Small molecule — Oral
Subject Tislelizumab Monoclonal antibody — Intravenous