NCT06911255

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

A Phase I/IIa, Single-arm, Open-label, IIT for Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination With Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Yoon Jun Kim · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma

Detailed description

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.

Conditions

• Hepatocellular Carcinoma (HCC)
• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Tremelimumab Plus Durvalumab (MEDI4736)	Study subjects will receive 1,500 mg of durvalumab intravenously every 4 weeks until PD is observed. However, treatment will be discontinued if unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria are met. Tremelimumab will be administered first, and durvalumab infusion will begin approximately 1 hour (up to 2 hours) after the completion of tremelimumab infusion. The standard infusion time for each drug is 1 hour, but if the infusion is temporarily interrupted, the total duration should not exceed 8 hours at room temperature.
PROCEDURE	Transarterial chemoembolization (TACE)	TACE will be carried out 1 to 2 weeks (7 to 14 days) after the administration of tremelimumab + durvalumab, and thereafter, it will be performed as needed at the discretion of the investigator during the treatment period. If additional TACE is performed, there must be at least a 1-week interval between the additional TACE and the administration of durvalumab.

Timeline

• Start date: 2025-04-18
• Primary completion: 2028-03-31
• Completion: 2028-06-30
• First posted: 2025-04-04
• Last updated: 2025-05-14

Locations

1 site across 1 country: South Korea