Clinical Trial of All-trans-retinoic Acid, Bevacizumab, and Atezolizumab in Colorectal Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT05999812
This study is exploring the effects of a combination of three drugs—All-trans-retinoic Acid (ATRA), Bevacizumab, and Atezolizumab—as a potential treatment for advanced colorectal cancer. Participants will receive these medications in a specific schedule to evaluate their benefits and side effects.
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Program Overview
The main goal of this clinical trial is to understand the positive and negative effects of using a combination of three drugs—All-trans-retinoic Acid (ATRA), Bevacizumab, and Atezolizumab—for treating advanced colorectal cancer. Participants will take ATRA pills at home twice daily for 7 days, starting on the first day of each treatment cycle. Atezolizumab and Bevacizumab will be administered through a vein in the arm or a mediport at a healthcare center every two weeks.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage IV colon cancer that has spread, confirmed by lab tests.
- Tumors must be from the colon, including those affecting the small bowel.
- Must have specific genetic markers related to DNA repair or stability.
- Have received at least two different chemotherapy treatments for metastatic cancer, including specific drugs unless not medically possible.
- Be 18 years or older.
- Be in good general health with a performance status score of 0 to 2.
- Have adequate organ and bone marrow function, as shown by specific blood tests.
- Negative HIV test, unless stable on treatment with a controlled viral load.
- Negative hepatitis B and C tests.
- Understand and agree to sign a consent form.
- Agree to use effective birth control during the study and for 6 months after treatment.
- Women must not be pregnant and must agree to a pregnancy test before starting treatment.
Exclusion Criteria
- Have a type of colorectal cancer with specific genetic instability.
- Have active autoimmune diseases or conditions requiring high doses of steroids.
- Have used Atezolizumab or ATRA before.
- Have had recent cancer treatments within 3 weeks before starting the study.
- Have untreated brain metastases.
- Have severe allergies to similar drugs used in the study.
- Have uncontrolled high blood pressure or significant heart disease.
- Have serious infections or other illnesses that could affect safety.
- Be pregnant or breastfeeding.
- Have had recent major surgery or plan to have surgery during the study.
- Have active hepatitis B or C, tuberculosis, or uncontrolled HIV.
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