Phase 1 Colorectal Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with colon cancer (or certain types of rectal cancer that was removed without needing radiation), confirmed by a tissue or cell sample analysis
• People with Stage II, Stage III, or Stage IV colorectal cancer who have had surgery with the goal of removing all cancer, and whose cancer is suitable for a standard two-drug chemotherapy plan for at least 3 months
• People whose blood test (called the Signatera MRD test) still shows cancer DNA circulating in the blood after at least 3 months of chemotherapy around the time of surgery
• People aged 18 or older
• People who are generally well enough to carry out basic daily activities (confirm with trial site for the specific fitness level required)
• People with a life expectancy of more than 3 months
• People whose blood counts and organ function (including bone marrow, liver, and kidneys) meet certain minimum levels as measured by blood tests (confirm with trial site for exact values)
• People who are able to use reliable contraception (such as hormonal methods, barrier methods, or abstinence) before, during, and for 90 days after the trial, if there is any possibility of pregnancy — this applies to both women who could become pregnant and to men
• People who are able to swallow tablets
• People who are willing and able to understand and sign a written consent form

Who may not be able to join:

• People who have had major surgery within the past 4 weeks, or chemotherapy or radiation therapy within the past 2 weeks before the trial starts
• People who still have significant side effects from previous cancer treatment (other than hair loss) that have not returned to a mild or baseline level
• People who are currently taking part in another clinical trial involving an experimental treatment
• People who have known spread of cancer to other parts of the body (metastases)
• People with a history of allergic reactions to drugs chemically similar to TAS-102, irinotecan, or other medicines used in this trial
• People with uncontrolled serious health conditions, such as an active infection, heart failure, unstable chest pain, heart rhythm problems, or mental health or personal circumstances that would make it difficult to follow the trial requirements
• People who have previously been treated with TAS-102 at any time, or with irinotecan within the past 90 days
• People who have had another type of cancer within the last 3 years, with the exception of certain early-stage or low-risk cancers (such as non-melanoma skin cancer, early-stage prostate cancer, or cervical cancer in its earliest localised form that was fully treated)
• People who, in the trial doctor's judgement, would be unable to follow the trial procedures and follow-up requirements
• People who are pregnant or breastfeeding, due to potential risks to a developing baby or nursing infant

Important: Always verify eligibility with the trial site directly before applying.