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

NCT06994299 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2025-11-18

No results posted yet for this study

Summary

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.

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

RADIATION

Radiation Therapy

Hypofractionated radiotherapy - 8Gy x3 fractions (week 0)

DRUG

Tremelimumab

Tremelimumab - single dose of 300 mg IV (week 0).

DRUG

Durvalumab

Durvalumab-500 mg IV every 4-weeks (weeks 0-3) prior to hepatic resection

PROCEDURE

Surgery

Hepatic resection

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Encouse Golden, M.D.,PHD · Weill Cornell Medicine, New York, NY, USA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-07-01
Completion
2028-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06994299 on ClinicalTrials.gov