Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Transarterial radioembolization (TARE) with yttrium-90 microspheres will be employed in combination with an intravenous (IV) dose of 1500 mg durvalumab every 4 weeks (Q4W) until PD. TARE will be performed 1-2 weeks (7 to 14 days) before the first dose of durvalumab and a maximum of 2 more times during the treatment period, per Investigator discretion. If additional TARE is performed, the interval between additional TARE treatments and administration of durvalumab should be at least 1 week.Masking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
This is a single arm, open-label study to evaluate safety and efficacy of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced and Unresectable Hepatocellular Carcinoma which to be implemented at a single site in Korea. Transarterial radioembolization (TA...
This is a single arm, open-label study to evaluate safety and efficacy of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced and Unresectable Hepatocellular Carcinoma which to be implemented at a single site in Korea. Transarterial radioembolization (TARE) with yttrium-90 microspheres will be employed in combination with an intravenous (IV) durvalumab until PD. TARE will be performed before the first dose of durvalumab. Exploratory biomarker testing will be done on tumor tissues prior to treatment and plasma samples prior to treatment and at the time of PD.
Tracking Information
- NCT #
- NCT04124991
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Yoon Jun Kim, MD. PhD Seoul National University Hospital