Study on Atezolizumab and Bevacizumab with Y90 Radioembolization for Liver Cancer Patients Awaiting Transplant
Sponsor: Icahn School of Medicine at Mount Sinai
ClinicalTrials ID:NCT07059494
This clinical trial is exploring a new treatment approach for liver cancer patients who are candidates for a liver transplant. The study combines a type of radiation therapy called Y90 radioembolization with two drugs, atezolizumab and bevacizumab, to see if it can help control liver cancer before a transplant.
Patient Parameters
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Program Overview
The study aims to test a combination of treatments for liver cancer patients who are either within or beyond certain criteria for liver transplant eligibility. The treatment includes Y90 radioembolization, a targeted radiation therapy, along with the drugs atezolizumab and bevacizumab. The goal is to see if this combination can help manage liver cancer effectively before a liver transplant.
Description
This trial is being conducted at a single institution and involves two groups of liver cancer patients. The first group includes patients who meet specific criteria for liver transplant but have high levels of a protein called AFP. The second group includes patients who are beyond the usual criteria for transplant but may still be eligible with treatment. The study will not include patients with cancer that has spread to major blood vessels or outside the liver, or those with very high AFP levels. The treatment involves using Y90 radioembolization, a type of radiation therapy that targets the liver, along with the drugs atezolizumab and bevacizumab, which help the immune system fight cancer. The study will assess if this combination can effectively control liver cancer before a transplant.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older and able to understand and sign a consent form.
- Must have a new diagnosis of liver cancer confirmed by a biopsy.
- Must provide a tumor sample for testing.
- Must have liver cancer that meets specific size and number criteria, with no spread to major blood vessels or outside the liver.
- Must have good overall health and organ function, as shown by specific blood tests.
- Must not have uncontrolled infections or other serious health conditions.
- Women of childbearing potential must have a negative pregnancy test and agree to use contraception.
- Must be eligible for the Y90 treatment and the drugs atezolizumab and bevacizumab.
Exclusion Criteria
- Very high levels of AFP protein in the blood.
- Cancer that has spread to major blood vessels or outside the liver.
- History of certain diseases affecting the brain or nervous system.
- Uncontrolled pain or other serious health conditions.
- Active infections or recent history of severe infections.
- Recent major surgery or other cancer treatments.
- Pregnant or breastfeeding women, or those planning to become pregnant.
- History of severe allergic reactions to similar treatments.
- Use of certain medications that could interfere with the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
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