Durvalumab and Lenvatinib in Participants With Locally Advanced and Metastatic Hepatocellular Carcinoma ( Dulect2020-1 )
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
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.