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

  • STATUS
    Recruiting
  • participants needed
    66
  • sponsor
    BeiGene
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Updated on 19 February 2024
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cancer
carcinoma
hepatocellular carcinoma
liver cancer
lenvatinib
cholangiocarcinoma
unresectable hepatocellular carcinoma
metastatic hepatocellular carcinoma
hepatocellular carcinoma metastatic

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).

Details
Condition Adenocarcinoma, Adenocarcinoma, HEPATIC NEOPLASM, liver cancer, HEPATOCELLULAR CARCINOMA, Metastatic Hepatocellular Carcinoma, liver cancer, Unresectable Hepatocellular Carcinoma
Age 18years - 70years
Treatment tislelizumab, Lenvatinib
Clinical Study IdentifierNCT04401800
SponsorBeiGene
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

Active autoimmune diseases or history of autoimmune diseases that may relapse
Any active malignancy 2 years before the first dose of study drugs except for specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast)
Uncontrolled diabetes or > Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management, or Grade 3 hypoalbuminemia 14 days before the first dose of study drugs
Any known brain or leptomeningeal metastases
Concurrent participation in another therapeutic clinical study
NOT: Other protocol defined Inclusion/Exclusion criteria may apply NOTE: Other
protocol defined Inclusion/Exclusion criteria may apply
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