The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Durvalumab 1500mg IV every 4 weeks for up to a maximum of 13 cycles (about 12 months) or until confirmed disease progression.
Tremelimumab 300 mg IV in combination with Durvalumab 1500mg about 2 weeks after their first DEB-TACE.
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Time frame: up to 26 months
Drug-related Toxicity
Number of participants experiencing drug-related adverse events (AE) Grade 3 or higher as defined by CTCAE v5.0
Time frame: up to 16 months
Progression Free Survival (PFS)
Progression free survival is defined as the time from start of the treatment until the documentation of disease progression according to mRECIST or death due to any cause, whichever occurs first. Estimation based on the Kaplan-Meier curve.
Time frame: up to 58 months
Overall Survival (OS)
Overall survival is the time from the start of first dose of study drug to death or end of follow-up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve.
Time frame: up to 58 months
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