Safety and Efficacy Study of Radioembolization in Combination With Durvalumab in Locally Advanced and Unresectable HCC

Sponsor
Seoul National University Hospital
Study ID
NCT04124991
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Radioembolization with Yttrium-90 Microspheres
  • Radioembolization — RADIATION
    Radioembolization with Yttrium-90 Microspheres

Study Details

Safety and Efficacy Study of Radioembolization with Yttrium-90 Microspheres in Combination with Durvalumab in Locally Advanced Hepatocellular Carcinoma

Key Dates

Start date
Jun 12, 2020
Status verified
Mar 2023
Primary completion
Jul 6, 2022
Completion
Jul 28, 2022

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Yttrium-90 Microspheres in Combination with Durvalumab
    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.

Primary Outcome Measure

TTP [ Time Frame: From date of enrollment until the date of first documented progression, assessed up to 12 months ]

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