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

NCT04425226 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-08-13

No results posted yet for this study

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.

Conditions

  • Liver Transplant; Complications
  • Hepatocellular Carcinoma Recurrent

Interventions

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

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Qiang Xia, MD., Ph.D. · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

  • Hao Feng, MD., Ph.D. · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2022-12-30
Completion
2024-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04425226 on ClinicalTrials.gov