Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Biliary Tract Cancer
- Hepatocellular Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administrati...
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of investigational drugs to learn whether the drugs work in treating a specific disease. "Investigational" means that the drugs are being studied. The FDA (the U.S. Food and Drug Administration) has not approved durvalumab for this specific disease but it has been approved for other uses. The FDA has not approved tremelimumab as a treatment for any disease. Both durvalumab and tremelimumab are antibodies (proteins that work with the immune system) that target proteins produced by the cancer cells. These cancerous proteins suppress the immune system which allows the cancer cells to grow. The study drugs may target these cancerous proteins and stop the cancer cells from suppressing the immune system. The investigators hope that the combination of these study drugs with radiation therapy will help stop the cancer cells from growing and spreading.
Tracking Information
- NCT #
- NCT03482102
- Collaborators
- AstraZeneca
- Investigators
- Principal Investigator: Theodore S. Hong, MD Massachusetts General Hospital
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