Phase 2 Colorectal Cancer Trial, Recruiting

Written by an AI model from 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 given written consent and are able to follow the study requirements.
• People aged 18 to 75 years old.
• People who have been diagnosed with colorectal cancer (a type of bowel cancer called adenocarcinoma), confirmed by a tissue sample test.
• People whose cancer has spread or cannot be removed by surgery, and has continued to grow or spread after at least two previous standard treatments.
• People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines.
• People who are in good enough general health to be mostly active and able to carry out daily activities (a doctor will assess this using a standard scale).
• People with a life expectancy of at least 3 months.
• People whose blood counts, liver function, and kidney function meet specific levels set by the trial (a doctor will check these through blood tests).
• Women who could become pregnant must have a negative pregnancy test within 3 days before starting the trial treatment.
• All participants who could potentially conceive a child must use highly effective contraception during treatment and for at least 120 days after the last dose of the trial drug, or 180 days after the last dose of chemotherapy if applicable.

Who may not be able to join:

• People who have had palliative radiotherapy for colorectal cancer within the 4 weeks before starting the trial.
• People who have used traditional Chinese medicine or Chinese herbal preparations to control their cancer within 7 days before starting the trial.
• People who have cancer that has spread to the brain or central nervous system and is causing symptoms, has not been treated, or is actively getting worse.
• People with other serious, uncontrolled health conditions, such as certain lung, liver, or neurological conditions (confirm with trial site).
• People with a current or past history of autoimmune diseases (where the immune system attacks the body) or immune deficiency conditions.
• People with a history of certain lung conditions, including scarring of the lung tissue, inflammation of the lung caused by medication, or signs of active lung inflammation on a screening scan.
• People who have had a serious active infection requiring treatment within 4 weeks before starting the trial.
• People who have had major surgery within 4 weeks before starting the trial, or who are expected to need major surgery during the trial.
• People with significant heart or cardiovascular conditions, including poorly controlled high blood pressure, unstable chest pain, irregular heart rhythms, a heart attack within the past 6 months, or a blood clot in the arteries or lungs within the past 3 months.
• People who have had another type of cancer within the past 2 years (other than the colorectal cancer being studied in this trial).
• People who have previously received immune checkpoint inhibitor treatments (a type of cancer immunotherapy), or certain immune-stimulating drugs within 4 weeks before the trial, or within 5 times the drug's clearance period — whichever is longer (confirm with trial site).
• People who have received chemotherapy, certain immunotherapy treatments, or any experimental therapy within 14 days before the trial, or within 5 times the drug's clearance period — whichever is longer.
• People who are HIV-positive, or who have active hepatitis B or hepatitis C infections.
• People who carry the hepatitis B virus must have virus levels below a specific limit and must be on antiviral treatment throughout the study. People with hepatitis C antibodies must have no detectable hepatitis C virus in their blood to be considered (confirm with trial site).
• People with any other condition that the trial doctor believes could put them at risk or cause them to leave the study early.
• People who have needed regular steroid medication (above a low dose threshold) or other immune-suppressing drugs within 14 days before starting the trial. Low-dose inhaled or skin-applied steroids, and low-dose replacement therapy for adrenal conditions, may be permitted (confirm with trial site).

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