Phase 3 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 been diagnosed with anal squamous cell carcinoma, or certain rectal squamous cell carcinomas that meet specific medical criteria (confirm with trial site for details on rectal cases)
• People whose cancer has been staged at a certain level using imaging scans — specifically stages that show the cancer has grown into surrounding tissue and/or spread to nearby lymph nodes, but has not spread to distant parts of the body
• People who have not had surgery to remove the tumor (other than a biopsy), chemotherapy, or any other cancer treatment before joining
• People aged between 18 and 75 years old
• People who are generally well enough to carry out daily activities with no more than minor limitations, as measured by a standard medical scale (ECOG 0–1)
• People whose blood counts, liver, kidney, and clotting results fall within acceptable ranges on recent blood tests
• People with no known allergy to the study drugs
• People who have not previously had radiation treatment to the area of the body that would be treated in this trial
• Women who are not pregnant and not breastfeeding
• People who are HIV-positive may still be considered, provided they are on a stable HIV treatment regimen, have a very low or undetectable viral load, and have a healthy immune cell count at the time of joining
• People who have read and signed a consent form agreeing to take part

Who may not be able to join:

• People whose squamous cell carcinoma started in the skin around the anus and has not spread into the anal canal or sphincter muscle (though cases where the main tumor involves the anal canal or sphincter may still be considered — confirm with trial site)
• People diagnosed with a condition called perianal Paget's disease
• Women who are pregnant or breastfeeding
• People with serious other health conditions or mental health conditions that the medical team considers would make participation unsafe or unsuitable
• People who have previously received certain types of immunotherapy drugs (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments) — note that HPV vaccines are not considered a reason for exclusion
• People who have had another cancer diagnosed within the past 3 years, with exceptions for certain fully treated skin cancers or completely removed early-stage cancers of the cervix, breast, or thyroid
• People who need to take immune-suppressing medications on an ongoing basis
• People with certain serious autoimmune conditions, such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, or others on a detailed list (confirm with trial site for the full list)
• People who have had an organ transplant or a bone marrow/stem cell transplant from a donor
• People whose recent blood test results do not meet the required levels within 7 days before enrolling
• People with significantly reduced function of the heart, liver, lungs, kidneys, or bone marrow
• People with serious uncontrolled health conditions or infections, including recent heart attack or heart failure, breathing failure, active hepatitis B or C, or active tuberculosis
• People currently taking part in another clinical trial or using another experimental drug
• People who are unwilling or unable to sign the consent form
• People with known allergies or medical reasons to avoid the study drug or its ingredients
• People who the medical team believes are unlikely to follow the study requirements

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