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

Trial number:
NCT04401800
Trial phase:
2
Study type:
Immunotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

September, 2020

Scientific title

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

Summary

The primary objective of this study is 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).

Key

Unresectable locally advanced or metastatic HCC, which must be confirmed by histologically or cytologically. Fibrolamellar, sarcomatoid, or mixed cholangiocarcinoma histology confirmed by histologically or cytologically is excluded.Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease that is not amenable to or has progressed after loco-regional therapy and is not amenable to a curative treatment approach Did not receive any systemic treatment before and is unwilling to accept standard of care treatment or not suitable for standard of care treatment as judged by investigators European Cancer Oncology Group (ECOG) Performance Status ≤ 1 Child-Pugh A classification for liver function assessed within 7 days of first dose of study drugs

Key

Study design

Primary purpose: Treatment, Allocation: Non-Randomized, Intervention model: Sequential Assignment, Masking: None (Open Label),

Conditions

Hepatocellular Carcinoma, Unresectable Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma

Other study ID numbers

BGB-A317-211; CTR20200972

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