NCT04443322

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

Safety and Efficacy Study of Durvalumab in Combination With Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma-- DULECT2020-1 Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The combination of Lenvatinib and Programmed death-ligand 1 (PD-L1) blocking has great potential in the treatment of locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC. This trial is designed as a prospective, open label study for 20 patients with locally advanced hepatocellular carcinoma before liver transplant and metastatic unresectable HCC. The aim is to investigate the efficacy of the combination therapy of Lenvatinib 80-120mg daily orally and durvalumab 1500mg by IV infusion every 4 weeks in terms of progression free survival.

Conditions

• Liver Carcinoma
• Liver Transplant; Complications

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-19
• Primary completion: 2021-12-31
• Completion: 2025-12-31
• First posted: 2020-06-23
• Last updated: 2020-09-22

Locations

1 site across 1 country: China