Spots Global Cancer Trial Database for Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus Infection
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Trial Identification
Brief Title: Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma With Hepatitis B Virus Infection
Official Title: A Randomized, Phase IIb Study of Lenvatinib Plus Nivolumab Versus Lenvatinib for Advanced Hepatocellular Carcinoma (HCC) With Hepatitis B Virus (HBV) Infection
Study ID: NCT04044651
Conditions
Study Description
Brief Summary: The purpose of this study is to investigate the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy for patients with advanced hepatitis B virus infection-related hepatocellular carcinoma.
Detailed Description: Lenvatinib was non-inferior to sorafenib in overall survival in untreated advanced hepatocellular carcinoma, and nivolumab was effective and tolerable in patients with advanced hepatocellular carcinoma. No study has evaluated the efficacy and safety of lenvatinib plus nivolumab compared with lenvatinib monotherapy. Thus, the investigators carried out this prospective, randomized, phase IIb study to find out it.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cancer Center Sun Yat-sen University, Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Guangzhou Twelfth People 's Hospita, Guangzhou, Guangdong, China
Contact Details
Name: Ming Shi, MD
Affiliation: Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
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