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 aged between 18 and 80 years old.
• People with a general health status rated as fully active or able to carry out light work (confirm with trial site for exact rating scale used).
• People who have been diagnosed with advanced or returning colorectal cancer (a type of bowel cancer) confirmed by laboratory testing of tissue samples.
• People whose cancer has been tested and shown to have normal DNA repair proteins (called pMMR) or a stable genetic pattern (called MSS), confirmed by laboratory testing.
• People whose blood test shows a specific cancer DNA marker (ctDNA maxVAF) below 6.5%, measured by a qualified testing company using a blood sample of 8–10ml.
• People whose colorectal cancer has spread to other parts of the body and has stopped responding to previous treatments including specific chemotherapy drugs (fluoropyrimidine, oxaliplatin, irinotecan) combined with certain targeted medicines (bevacizumab, or cetuximab for those with left-sided tumours of a specific genetic type).
• People who finished their last cancer treatment at least 28 days ago (or at least 14 days for certain oral chemotherapy), with limited palliative radiation therapy allowed if completed more than 3 weeks before joining.
• People who have at least one tumour that can be measured on a scan, according to standard medical criteria.
• People with an expected survival of at least 3 months.
• People whose blood tests taken within 7 days before joining show that their blood cell counts, liver function, kidney function, and blood clotting are all within acceptable ranges (confirm with trial site for specific values).
• People with a normal heart tracing (ECG) and adequate heart pumping function (at least 50% on a standard heart scan).
• People with no history of other cancers, except for certain early-stage or fully cured cancers, or cancers where the person has been cancer-free for 5 or more years after surgery.
• Women who could become pregnant must have a negative pregnancy test and agree to use effective contraception throughout the trial.
• People who agree to take part voluntarily and provide written informed consent.

Who may not be able to join:

• People who have previously been treated with fruquintinib or similar oral targeted medicines primarily designed to stop blood vessel growth in tumours.
• People who have previously received certain immunotherapy medicines that target PD-1, PD-L1, or CTLA-4 pathways.
• People who have had a severe allergic reaction to a monoclonal antibody (a type of targeted medicine) in the past.
• People with an active autoimmune disease (where the immune system attacks the body) or a history of one, such as autoimmune liver disease, certain lung conditions, bowel inflammation, blood vessel inflammation, or kidney inflammation — though people with certain mild or well-controlled conditions such as vitiligo, psoriasis, hair loss not needing treatment, well-controlled type 1 diabetes, or thyroid conditions stable on medication may still be considered (confirm with trial site).
• People currently taking immune-suppressing medicines, including steroid tablets above a certain dose, within 2 weeks of starting the trial.
• People who have difficulty swallowing or absorbing oral medicines, such as those with difficulty swallowing, certain bowel surgery, ongoing severe diarrhoea, or bowel blockage.
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires repeated draining.
• People with a history or signs of serious bleeding problems, a significant bleeding event within the 4 weeks before starting the trial, or unhealed wounds, fractures, active stomach ulcers, bowel ulcers, or other conditions that could cause serious bleeding or bowel perforation.
• People with known cancer spread to the brain, or a history of organ transplantation.
• People who received any cancer treatment (including chemotherapy, surgery, radiation, targeted therapy, immunotherapy, or certain traditional medicines) within 4 weeks before starting the trial, or who still have side effects from previous treatments that have not sufficiently resolved (confirm with trial site for specific details).
• People who received a live or preventive vaccine within 4 weeks before the first dose.
• People with poorly controlled high blood pressure (systolic at or above 150 mmHg or diastolic at or above 90 mmHg).
• People who had a blood clot, stroke, heart attack, significant heart failure, or certain heart rhythm problems within 6 months before joining.
• People with active or poorly controlled serious infections, or tuberculosis.
• People with active hepatitis B or C infection confirmed by blood tests, HIV infection, other serious liver disease, or poorly controlled diabetes (confirm with trial site for specific test thresholds).

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