NCT06994299

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2025-05-29
• Last updated: 2025-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study