Spots Global Cancer Trial Database for Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma
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Trial Identification
Brief Title: Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma
Official Title: The Combination of Pembrolizumab and Lenvatinib as Neoadjuvant Treatment for Hepatocellular Carcinoma Patients: a Single Arm Phase II Study
Study ID: NCT05389527
Conditions
Interventions
Study Description
Brief Summary: This is an open-label, multi-center, single-arm, phase II study to evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab as a neoadjuvant therapy in subjects with resectable hepatocellular carcinoma (HCC).
Detailed Description: The recurrence rate of hepatocellular carcinoma (HCC) after curative surgery is high and the survival benefit is limited. Neoadjuvant therapy, by targeting the disseminated tumor cells before curative surgery, may lower the incidence of tumor recurrence. In KEYNOTE-524 study, lenvatinib plus pembrolizumab combination showed promising efficacy and manageable toxicity. This study will evaluate the efficacy and safety of lenvatinib in combination with pembrolizumab as a neoadjuvant therapy in subjects with resectable HCC.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Zhongshan hospital, Shanghai, Shanghai, China
Eastern Hepatobiliary Surgery Hospital, Shanghai, Shanghai, China
Ruijin Hospital, Shanghai, Shanghai, China
The first affiliated hospital, Yat-sen university, Guangzhou, , China
Contact Details
Name: Huichuan Sun
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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