Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )

Sponsor
RenJi Hospital
Study ID
NCT04443322
Status
Unknown

Conditions

  • Liver Carcinoma
  • Liver Transplant; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab Injection — DRUG
    Anti-PD-L1 Monoclonal Antibody
  • Lenvatinib 4 MG — DRUG
    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 etc.

Study Details

This study will evaluate the safety and efficacy of durvalumab in combination with lenvatinib in participants with locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC.The primary hypothesis of this study are that patients with locally advanced HCC could benefit from durvalumab plus lenvatinib before liver transplant; patients with metastatic unresectable HCC could also benefit from durvalumab plus lenvatinib with respect to: 1)Progression Free Survival (PFS) ; or recurrence-free survival (RFS) if patients with locally advanced HCC underwent liver transplant; 2) Objective Response Rate (ORR); and 3) Overall survival (OS). The investigators design a clinical study to explore whether the combination above as a treatment in patients with advanced and recurrent endometrial carcinoma could prolong PFS and to analyze potential immune biomarker of therapeutic response.

Key Dates

Start date
Sep 19, 2020
Status verified
Jun 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab and Lenvatinib
    Participants receive intravenous (IV) durvalumab at 1500mg on Day 1 of each 28-day cycle. Number of cycles: until unacceptable toxicity develops or \>42 days before liver transplantation (If patients with locally advanced HCC would undergo liver transplant). Patients receive Lenvatinib 8-12mg(basing on weight), once a day, oral at least 38 days of each 6 weeks cycle until \>7 days before liver transplantation(If patients with locally advanced HCC would undergo liver transplant).

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 3 years ]

Central Contacts

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