Phase 3 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:

• The patient and their family are able to understand the study and are willing to sign a consent form agreeing to take part
• Adults aged 18 to 75 years old, of any gender
• A tissue sample (biopsy) has confirmed the person has rectal cancer of a specific type called tubular adenocarcinoma, graded as high, intermediate, or low grade, and with a specific biological profile (called pMMR or MSS) confirmed by laboratory testing
• The cancer is in the middle or lower part of the rectum, with the bottom edge of the tumour within 10 cm of the opening of the back passage
• The cancer has certain high-risk features on scans — specifically, the tumour has grown into surrounding structures (cT4), cancer has spread to multiple nearby lymph nodes (cN2), the tumour is close to or touching the surgical margin on MRI (mrMRF+), cancer cells are found in nearby blood or lymph vessels on MRI (EMVI+), or lymph nodes on the side walls of the pelvis are involved
• The cancer has not spread to distant parts of the body
• The person is in good general health and able to carry out daily activities with little or no limitation (ECOG score 0 or 1)
• Hepatitis B and C blood test results meet specific requirements — people with certain positive results may still be considered if the level of hepatitis B virus in the blood is below a defined threshold (confirm with trial site)
• Women of childbearing age have a negative pregnancy test before starting the trial
• People who are able to have children (either women or men whose partners could become pregnant) agree to use reliable contraception throughout the study and for 120 days after it ends
• The person has not previously had radiotherapy to the pelvis
• The person has not previously had surgery or chemotherapy for rectal cancer
• The person does not have an active body-wide infection currently requiring antibiotic treatment
• The heart, lungs, liver, and kidneys are healthy enough to tolerate surgery

Who may not be able to join:

• The rectal cancer has come back after previous treatment (recurrent cancer)
• The person's general health is more significantly limited, with an ECOG score of 2 or higher
• The person has had a serious heart or brain blood vessel event in the 6 months before joining, such as a stroke, heart attack, unstable chest pain, or a type of irregular heartbeat that cannot be controlled, including abnormal heart rhythm measurements on an ECG above specific thresholds
• The person has severe heart failure (classified as Grade III or IV by standard medical criteria) or heart pumping function below 50% on an ultrasound of the heart
• The person has high blood pressure that cannot be brought under control with medication
• Urine tests show a significant level of protein in the urine, above defined thresholds
• The person has a weakened immune system, including HIV infection, other immune deficiency conditions present from birth or developed over time, or a history of organ or bone marrow transplant
• The person received a live vaccine within 28 days before starting the trial (standard inactivated flu vaccines are generally excepted — confirm with trial site)
• The person has or has had a known active or suspected autoimmune disease (some conditions managed with standard hormone or insulin replacement may still be eligible — confirm with trial site)
• The person has active tuberculosis
• The person has or has had certain lung conditions such as interstitial lung disease, dust-related lung disease, radiation-related lung damage, or drug-related lung inflammation, or has severely reduced lung function
• The person has previously been treated with certain types of targeted cancer drugs or immunotherapy drugs, including PD-1 inhibitors, PD-L1 inhibitors, or CTLA-4 inhibitors
• The person has a known serious allergy to any of the drugs used in this trial or their ingredients
• The person has a history of significant bleeding from organs, or a tendency to bleed (bleeding from the rectal tumour itself is assessed separately by the trial doctor)
• The person has previously had another type of cancer
• The person has previously received other anti-cancer or experimental treatments
• The person is currently pregnant or breastfeeding
• The person has a condition affecting the brain or nervous system, or a mental health condition, that could affect safe participation in the study
• The person has other serious ongoing health conditions that the trial doctor considers would make participation unsafe

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