RecruitingPhase 2NCT04430452

Durvalumab With/Without Tremelimumab After Palliative Hypofractionated Radiotherapy for Hepatocellular Carcinoma

Phase II Trial of Durvalumab (MEDI4736) With/Without Tremelimumab for Advanced Hepatocellular Carcinoma After Palliative Hypofractionated Radiotherapy


Sponsor

Mary Feng, MD

Enrollment

21 participants

Start Date

Feb 4, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial studies how well standard of care hypofractionated radiation therapy followed by durvalumab with or without tremelimumab works in treating patients with hepatocellular cancer (liver cancer) that has spread to other places in the body (advanced) and that is growing, spreading, or getting worse (progressing). In some patients, cancer cells and immune cells start to express signals that stop the body's immune system from killing the cancer. New drugs being developed, such as durvalumab and tremelimumab, are designed to target and block these signals and may help increase the immune response to prevent or slow down cancer growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may help the immune system work even better. Giving durvalumab with or without tremelimumab after radiation therapy may work better than radiation therapy alone in treating patients with liver cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding immunotherapy drugs (durvalumab with or without tremelimumab) after targeted radiation can help people with liver cancer (HCC) whose disease has progressed after prior immunotherapy. **You may be eligible if...** - You have been diagnosed with liver cancer (hepatocellular carcinoma) - Your cancer progressed after previous immunotherapy (such as nivolumab or pembrolizumab) - Your liver is still functioning adequately - You are 18 or older **You may NOT be eligible if...** - You have had prior radiation to the same liver tumor sites - You have received prior durvalumab - You have active autoimmune disease - You have had a liver transplant - 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

BIOLOGICALDurvalumab

Given IV

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated RT

BIOLOGICALTremelimumab

Given IV


Locations(1)

University of California, San Francisco

San Francisco, California, United States

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NCT04430452


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