Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Antibodies

Antibodies, Monoclonal

Lenvatinib

Angiogenesis Inhibitors

Durvalumab

Immunoglobulins

Liver Extracts

Endothelial Growth Factors

Mitogens

Antineoplastic Agents, Immunological

Immunologic Factors

Protein Kinase Inhibitors

Enzyme Inhibitors

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).

Durvalumab Injection

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.

Lenvatinib 4 MG

Hao Feng, MD., Ph.D.

Hao Feng, MD, PhD

Jian-jun Zhang, MD

Qiang Xia, MD

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.

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.

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

Defined as time from randomisation to first progression by investigator assessment using modified RECIST 1.1 or death (by any cause in the absence of progression)

If patients with locally advanced HCC would undergo liver transplant after neoadjuvant treatment of Durvalumab and Lenvatinib.RFS is defined as the time from randomization to first documentation of disease recurrence (local, regional, or distant) as assessed by BICR or by pathology consistent with HCC if required per the site's standard of care, or death due to any cause (both cancer and non-cancer causes of death)

Proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response and partial response patients.

Defined as the time from randomisation to death due to any cause

An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined.

RenJi Hospital

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )	NCT04443322	Liver Carcinoma Liver Transplan...	Durvalumab Inje... Lenvatinib 4 MG	18 Years - 80 Years	RenJi Hospital
Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )	NCT04443322	Liver Carcinoma Liver Transplan...	Durvalumab Inje... Lenvatinib 4 MG	18 Years - 80 Years	RenJi Hospital

Spots Global Cancer Trial Database for lenvatinib 4 mg