Radiation and Immunotherapy for Liver Cancer

(PRISM Trial)

Overseen By Fabiana Gregucci, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Weill Medical College of Cornell University

Must not be taking: High-dose steroids

Disqualifiers: Other malignancy, Autoimmune disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 4

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Encouse Golden, M.D.,PHD

Principal Investigator

Weill Cornell Medicine, New York, NY, USA

Eligibility Criteria

This trial is for individuals with resectable/advanced hepatocellular carcinoma, which is a type of liver cancer. Participants should be suitable for MRI or CT-guided radiotherapy and immunotherapy. Specific eligibility criteria are not provided but typically include factors like age, overall health, and the stage of cancer.

Inclusion Criteria

Patient must have measurable disease defined as a lesion that can be accurately measured in at least one dimension and measures ≥ 15 mm with conventional techniques or ≥ 10 mm with more sensitive techniques such as MRI or spiral CT scan.

I weigh more than 30kg.

My liver cancer is confirmed by a high-level scan or biopsy.

Exclusion Criteria

Patients must not be scheduled to receive another experimental drug while on this study.

Any underlying medical condition, which, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events.

Patients with prior orthotropic liver transplantation.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation and Immunotherapy

Participants receive MRI-guided or CT-guided radiotherapy in three sessions (8 Gy each) and immunotherapy with a single dose of Tremelimumab and regular doses of Durvalumab every four weeks

7 weeks

3 radiation sessions, 1 Tremelimumab dose, 2 Durvalumab doses

Surgery

Participants undergo hepatic resection

1 week

1 surgical visit

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Durvalumab
• MRI-guided or CT-guided Radiotherapy
• Tremelimumab

Trial Overview The study tests a new treatment combining radiation therapy (three sessions using MRI or CT guidance) with immunotherapy drugs Tremelimumab (one dose) and Durvalumab (every four weeks). The aim is to evaluate the safety and potential effectiveness of this regimen in treating liver cancer.

Participant Groups

Group I: Stereotactic Body Radiotherapy for HCC Experimental Treatment 4 Interventions

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)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+