RecruitingPhase 1NCT05701488

SIRT With Tremelimumab and Durvalumab for Resectable HCC

A Phase 1 Neoadjuvant Trial of Selective Internal Yttrium-90 Radioembolization (SIRT) With Tremelimumab and Durvalumab (MEDI4736) for Resectable Hepatocellular Carcinoma


Sponsor

Jiping Wang, MD, PhD

Enrollment

20 participants

Start Date

Apr 21, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a targeted radiation therapy directly to liver tumors (called SIRT, which uses tiny radioactive beads), along with two immunotherapy drugs (tremelimumab and durvalumab), can shrink liver cancer enough to allow surgery in people who haven't been treated before. **You may be eligible if...** - You are 18 or older and weigh more than 30 kg - You have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) - Your cancer has not been treated before - Your tumor can potentially be removed with surgery - Your liver is functioning well - Your blood counts, liver, and kidney tests are within acceptable ranges - You are able to use contraception if you can become pregnant **You may NOT be eligible if...** - You have already received any treatment for liver cancer - You have had a major surgery or serious injury in the past 6 weeks - You have had an organ transplant - You have an active autoimmune condition (like lupus, Crohn's, or rheumatoid arthritis) - You have HIV/AIDS, active hepatitis B, or active hepatitis C - You are currently taking immune-suppressing medications - You have brain tumors or brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDurvalumab

Intravenous infusion

DRUGTremelimumab

Intravenous infusion

DEVICESIRT

SIR (Selective Internal Radiation) Sphere resin microspheres, radioactive particles delivered via injection into an artery.


Locations(3)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05701488


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