Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma

The purpose of this clinical trial is to evaluate the safety and efficacy of tremelimumab + durvalumab administered concurrently with transarterial chemoembolization (TACE) in patients diagnosed with hepatocellular carcinoma (HCC) who are not eligible for curative liver resection.

Primary Objective:

The primary objective of this clinical trial is to evaluate progression-free survival (PFS) from the time of registration using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Secondary Objectives:

Overall Survival (OS):

To assess the overall survival from the first dose of the study drug until the data cutoff point, as determined by the investigator.

Objective Response Rate (ORR):

To assess the objective response rate of target and non-target lesions using mRECIST and RECIST 1.1. Evaluations will occur every 8 weeks after 12 weeks and for the first 48 weeks from the time of registration, and then every 12 weeks thereafter.

Time to Progression (TTP):

To measure the time from registration to disease progression using mRECIST and RECIST 1.1.

Safety Evaluation:

To evaluate the safety of tremelimumab and durvalumab, including adverse events, vital signs (blood pressure and pulse rate), and laboratory safety assessments (clinical chemistry, hematology, etc.), by assessing changes from baseline.