SIRT With Tremelimumab and Durvalumab for Resectable HCC

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jiping Wang, MD, PhD
Study ID
NCT05701488
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    Intravenous infusion
  • Tremelimumab — DRUG
    Intravenous infusion
  • SIRT — DEVICE
    SIR (Selective Internal Radiation) Sphere resin microspheres, radioactive particles delivered via injection into an artery.

Study Details

The goal of this research study is to evaluate the safety and tolerability of tremelimumab and durvalumab with or without Selective Internal Yttrium-90 Radioembolization (SIRT) in participants with resectable hepatocellular carcinoma (HCC) who will undergo liver surgery. The names of the interventions involved in this study are: * Durvalumab (a type of immunotherapy) * Tremelimumab (a type of immunotherapy) * Selective Internal Yttrium-90 Radioembolization (SIRT) (a type of radiation microsphere bead)

Key Dates

Start date
Apr 21, 2023
Status verified
Aug 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Tremelimumab (Arm A)
    -Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined: Neoadjuvant Treatment: * Cycle 1: * Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab * Day 28 of 28 Day cycle: Pre-determined dose of Durvalumab * Participants will undergo surgery on day 49 of Cycle 1. Surgery will be performed per institutional standard of care. Adjuvant Treatment: --Cycles 1 (28 days postoperatively) - 13: ---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab
  • Experimental: Durvalumab + Tremelimumab + SIRT (Arm B)
    -Participants will be randomized into the treatment group in a 1:1 ratio and will receive interventions as outlined: Neoadjuvant Treatment: * Cycle 1: * Day 3 of 28 Day Cycle: Pre-determined dose of Durvalumab and Tremelimumab * Day 31 of 28 Day Cycle: Pre-determined dose of Durvalumab * Day 1 of 28 Day Cycle: Yttrium-90 * Participants will undergo surgery on Day 52 of Cycle 1. Surgery will be performed per institutional standard of care. Adjuvant Treatment: --Cycles 1 (28 days postoperatively) - 13: ---Day 1 of 28 Day Cycle: Pre-determined dose of Durvalumab

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: up to 18 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jane Martin, RN
[email protected]
617-975-7413
Dana-Farber Cancer InstituteBostonMassachusetts02215
Jiping Wang, MD, PhD
[email protected]
617-732-8910

Find similar trials in Los Angeles, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Cedars-Sinai Medical Center· Los Angeles, CABeth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MA

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