A Pilot Trial of Preoperative Irradiation With the STRIDE (Single Dose of Tremelimumab With Ongoing Durvalumab) Regimen (PRISM) for Resectable/Advanced Hepatocellular Carcinoma

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT06994299
Phase
PHASE2
Status
Withdrawn

Conditions

  • Hepatocellular Carcinoma (HCC)

Eligibility Criteria

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

Interventions

  • Radiation Therapy — RADIATION
    Hypofractionated radiotherapy - 8Gy x3 fractions (week 0)
  • Tremelimumab — DRUG
    Tremelimumab - single dose of 300 mg IV (week 0).
  • Durvalumab — DRUG
    Durvalumab-500 mg IV every 4-weeks (weeks 0-3) prior to hepatic resection
  • Surgery — PROCEDURE
    Hepatic resection

Study Details

This is an early-phase study testing a new combination treatment for cancer. participants will receive a type of radiation therapy called MRI-guided or CT-guided radiotherapy, depending on which imaging method is safe for them. The radiation will be given in three sessions, each delivering a moderate dose (8 Gray), focused only on the visible tumor. At the same time, participants will receive immunotherapy, which is a treatment that helps the immune system fight cancer. This includes one dose of a drug called Tremelimumab and regular doses of another drug called Durvalumab, given every four weeks. The goal of this study is to see if this combination is safe and shows signs of helping patients.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2025
Primary completion
Jul 1, 2027
Completion
Jul 1, 2028

Study Design

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

Arms

  • Experimental: Stereotactic Body Radiotherapy for HCC
    Hypofractionated radiotherapy - 8Gy x3 fractions (week 0) Tremelimumab - single dose of 300 mg IV (week 0). Durvalumab - 1500 mg IV every 4-weeks (weeks 0-3) prior to hepatic resection Surgery - hepatic resection (week 7)

Primary Outcome Measure

Safety, as measured by the number of Grade 3+ CTCAE treatment related toxicity rates within three months from start of treatment [ Time Frame: Within 3 months from start of treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
New York-Presbyterian Weill Cornell Medical CollegeNew YorkNew York11355-

Find similar trials in New York, NY

By research site
New York-Presbyterian Weill Cornell Medical College· New York, NY

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