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 are able to give written consent and are willing to attend all required visits and follow the study procedures.
• People aged 18 to 75 years old, of any gender.
• People who have been diagnosed with colorectal cancer (confirmed by laboratory testing of tissue or cells) that cannot be surgically removed and has either spread to nearby areas or to other parts of the body, and whose cancer has a specific biological profile called pMMR/MSS.
• People whose cancer has stopped responding to standard treatments, who were unable to tolerate standard treatments, who have no standard treatment options remaining, or who have declined standard treatment.
• People whose recent blood test results (taken within 7 days before starting the study) show that red blood cell levels, white blood cell levels, platelets, and a type of white blood cell called eosinophils are all within the ranges required by the trial, without having needed blood transfusions or certain supportive medications in the 7 days before testing.
• People whose recent liver and kidney function blood test results (within 7 days before starting the study) meet the specific levels required by the trial, including results for liver enzymes, bilirubin, kidney function, and protein levels in the blood.
• People whose recent blood clotting test results (within 7 days before starting the study) fall within acceptable ranges, including for those already on a stable dose of blood-thinning medication.
• People whose recent urine test results (within 7 days before starting the study) show protein levels in the urine are below the threshold required by the trial.
• People who have at least one area of cancer that can be measured using standard imaging guidelines (RECIST v1.1).
• People who are reasonably active and able to care for themselves, as measured by a standard scale used in cancer research (ECOG performance status of 0 or 1).
• People who are expected to live for at least 3 months.
• People who agree to use highly effective contraception during the treatment period and for 6 months after the last dose — this applies to male participants whose partners could become pregnant, and to female participants who could become pregnant.

Who may not be able to join:

• People whose colorectal cancer has a different biological profile called MSI-H or dMMR (only pMMR/MSS cancers are eligible for this trial).
• People who have had a known allergic reaction to any of the study drugs, including PD-1 inhibitor medications or a drug called pirfenidone.
• Female patients who are currently pregnant, breastfeeding, or planning to become pregnant within 6 months after the last dose of the study drug.
• People with a known history of active seizures, active cancer spread to the brain or spinal cord, or cancer affecting the membranes surrounding the brain or spinal cord.
• People with serious heart or blood vessel conditions that are clinically significant.
• People with a history of allergic conditions, asthma, or a chronic skin condition called atopic dermatitis.
• People who have a large build-up of fluid in the chest cavity or abdomen.
• People who have an active autoimmune disease that required ongoing medical treatment (such as steroids or immune-suppressing medications) within the past 2 years — hormone replacement therapy is not included in this restriction.
• People who have had an organ transplant or a stem cell transplant from another person.
• People with a known or suspected allergy to the study drugs or their ingredients (confirm with trial site, as this overlaps with criterion 2 above).
• People who previously had to permanently stop taking an immune checkpoint inhibitor or pirfenidone due to serious side effects.
• People who still have unresolved side effects above a mild level from previous cancer treatments, with some exceptions such as persistent hair loss, mild nerve-related symptoms, mildly low red blood cell levels, or low magnesium levels.
• People with active uncontrolled bleeding, known tendency to bleed, serious wounds that are not healing, ulcers, fractures, or certain conditions affecting blood vessels in the digestive system that carry a high risk of bleeding.
• People with a recent or unresolved history of bowel blockage (unless fully resolved by surgery) or a risk of a hole forming in the gut, within 28 days before starting the study.
• People with current or recent (within 6 months) significant gut-related problems, including a history of clinically meaningful bleeding in the digestive tract, active stomach ulcers, or diarrhoea of moderate severity or worse within 2 weeks before starting the study.
• People with gut diseases or previous gut surgeries that may affect how the body absorbs the oral study drug pirfenidone, or people with uncontrolled cancer-related pain or high calcium levels in the blood causing symptoms.
• People who are known to be HIV positive, or who have active hepatitis B, active hepatitis C, or active tuberculosis — some exceptions may apply for people with hepatitis B or C whose virus levels are very low or undetectable (confirm with trial site).
• People who have a severe, active, or uncontrolled infection, who require intravenous antibiotics, or who have had an unexplained fever above 38°C within 2 weeks before starting the study.
• People who have been diagnosed with another type of cancer within the past 5 years, with some exceptions for certain fully treated skin cancers or localised prostate or thyroid cancer treated with the aim of cure.
• People who have received certain treatments too recently before starting the study, including chemotherapy, targeted therapy, antibody-based treatments, other clinical trial treatments, radiotherapy for symptom relief, live vaccines, immune-suppressing medications or high-dose steroids, or who have had major surgery within 4 weeks, or unstable blood clotting conditions or significant bleeding events within 6 months.
• People whose overall health, other conditions, or personal circumstances are judged by the trial doctor to make participation unsafe or unsuitable.
• People who are otherwise considered unsuitable for the trial by the trial investigator.

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