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

NCT04443322 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Liver Carcinoma
  • Liver Transplant; Complications

Interventions

DRUG

Durvalumab Injection

Anti-PD-L1 Monoclonal Antibody

DRUG

Lenvatinib 4 MG

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Jian-jun Zhang, MD · Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU

  • Qiang Xia, MD · 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
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-09-19
Primary Completion
2021-12-31
Completion
2025-12-31

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 NCT04443322 on ClinicalTrials.gov