Liver Transplant; Complications Clinical Trial
Official title:
Safety and Efficacy Study of Pembrolizumab in Combination With LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant as Neoadjuvant TherapY--PLENTY Randomized Clinical Trial
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.
Participates would be randomly assigned (1:1) to experimental or Comparator/Control by computer-generated allocation based on the envelope method and the hierarchical block randomization method(hierarchy: BCLC stage and AFP level). The envelopes are sealed opaque, and sequentially numbered.Randomization is performed by the trial coordinator.The random number table and the block assignment number table will be kept confidential by the full-time secretary of this project.Center-stratified block-permuted randomization is used in this trial. Then permuted block randomization is used for each stratum with a block size of 4. ;
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