NCT04425226

Pembrolizumab and LENvatinib in Participants With Hepatocellular Carcinoma (HCC) Before Liver Transplant

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Liver Transplant; Complications
• Hepatocellular Carcinoma Recurrent

Interventions

Type	Name	Description
DRUG	Pembrolizumab Injection [Keytruda]	Pembrolizumab (Keytruda, MSD China) is a recombinant anti-human PD-1 monoclonal antibody.
DRUG	Lenvatinib Oral Product	Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT

Timeline

• Start date: 2020-08-06
• Primary completion: 2022-12-30
• Completion: 2024-12-30
• First posted: 2020-06-11
• Last updated: 2020-08-13

Locations

1 site across 1 country: China