Phase 3 Study of BGB-A317 Versus Sorafenib in Patients With Unresectable HCC

  • STATUS
    Not Recruiting
  • End date
    May 19, 2022
  • participants needed
    660
  • sponsor
    BeiGene
Updated on 24 January 2021

Summary

This is a Phase 3, randomized, open-label, multicenter, global study designed to compare the efficacy and safety of BGB-A317 versus sorafenib as a first-line systemic treatment in patients with unresectable hepatocellular carcinoma. This study also includes a substudy investigating the safety, tolerability, PK, and preliminary efficacy in HCC in Japanese patients. In Japan, preliminary safety and tolerability will be evaluated (Safety Run-In Substudy) before Japanese patients are recruited in this Phase 3 study.

Details
Condition HEPATOCELLULAR CARCINOMA
Treatment Sorafenib, BGB-A317
Clinical Study IdentifierNCT03412773
SponsorBeiGene
Last Modified on24 January 2021

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