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

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.

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.