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Pembrolizumab and Lenvatinib for Resectable Hepatocellular Carcinoma — NeoLeap-HCC  

Carcinoma, Hepatocellular Clinical Trial

Official title:
The Combination of Pembrolizumab and Lenvatinib as Neoadjuvant Treatment for Hepatocellular Carcinoma Patients: a Single Arm Phase II Study

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05389527
Study type Interventional
Source Shanghai Zhongshan Hospital
Contact
Status Active, not recruiting
Phase Phase 2
Start date September 30, 2022
Completion date July 31, 2025
View Details
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