Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
Objectives of Study：This study will evaluate the safety and efficacy of pembrolizumab in
combination with lenvatinib as neoadjuvant therapy in participants with hepatocellular
carcinoma (HCC) exceeding Milan criteria before liver transplant.
The primary hypothesis of this study are that neoadjuvant pembrolizumab plus lenvatinib is
superior to regularly waiting in the list with respect to: 1) recurrence-free survival (RFS)
as assessed by blinded independent central review (BICR); and 2) Objective Response Rate
(ORR).The investigators design a clinical study to explore whether the combination above as a
neoadjuvant treatment in patients with advanced HCC before liver transplant could reduce
postoperative recurrence and to analyze potential immune biomarker of therapeutic response.