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 18 to 75 years old at the time of signing the consent form.
• People with a good general health and activity level, rated at 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People whose cancer has come back in the pelvic area, confirmed by MRI or CT scan, with at least one measurable tumour in that area.
• People who have no more than 5 areas of cancer spread to distant parts of the body, and no more than 3 different organs affected by that spread.
• People who have not had radiotherapy in the 6 months before joining the trial.
• People who fall into one of two groups: those whose pelvic cancer has returned and who have not yet had first-line chemotherapy (Cohort A), or those whose cancer has grown or new tumours have appeared after first-line chemotherapy (Cohort B).
• People whom the study doctor estimates have a life expectancy of at least 24 weeks.
• People whose bone marrow, liver, kidney, and blood clotting functions are all within acceptable levels, as tested within 7 days before starting the trial, without the need for blood products or growth factor support.
• People who are not currently pregnant or breastfeeding, and who are willing to use effective contraception during the study and for 6 months after the last dose.
• People who have been fully informed about the trial and are willing to sign a written consent form.

Who may not be able to join:

• People whose blood cell counts (white blood cells, platelets, or haemoglobin) are below the required levels, or who have needed a blood transfusion in the 2 weeks before enrolment.
• People with liver function test results above acceptable limits (higher thresholds may apply for those with liver metastases).
• People with elevated liver enzyme levels (AST or ALT) above acceptable limits (higher thresholds may apply for those with liver metastases).
• People with kidney function below the required level, based on blood creatinine levels or a calculated kidney function score.
• People with blood clotting test results (APTT or PT) above acceptable limits.
• People with serious imbalances in their body's electrolytes (such as sodium, potassium, or calcium).
• People with significant protein detected in their urine.
• People with uncontrolled high blood pressure (above 140/90 mmHg).
• People with active stomach or bowel conditions such as ulcers, ulcerative colitis, unremoved tumours with active bleeding, unhealed bowel perforations, or bowel fistulas.
• People who have had a blood clot in an artery or deep vein in the past 6 months, or any significant bleeding or tendency to bleed in the past 2 months.
• People who have had a serious heart condition in the past 6 months, including heart failure, heart attack, severe chest pain, bypass surgery, or significantly reduced heart pumping function.
• People with uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart.
• People who have previously been treated with certain types of immunotherapy that target immune checkpoint proteins (such as anti-PD-1, PD-L1, PD-L2, or CTLA-4 therapies).
• People with a currently detectable second cancer, or a history of another cancer within the past 5 years (except for certain treated skin cancers, early-stage cervical changes, or certain superficial bladder tumours).
• People with a history of hepatitis B or C infection, positive results on related virus tests above specified levels, or liver cirrhosis.
• People who are pregnant, breastfeeding, have a positive pregnancy test before starting treatment, or who are unwilling to use reliable contraception during the study.
• People whom the study doctor considers unsuitable for the trial due to any medical, laboratory, or compliance concerns.
• People with serious mental health conditions.
• People with brain metastases larger than 3 cm in diameter or with a total brain metastasis volume greater than 30 cc.
• People with evidence of spinal cord compression, or tumours located within 3 mm of the spinal cord as seen on MRI.

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