Phase 2 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:

• People who have been confirmed by a laboratory test (biopsy) to have squamous cell carcinoma of the anal canal or anal margin at certain stages, including some who have had the main tumor surgically removed but still have cancer in nearby lymph nodes or remaining disease.
• People aged 18 or older.
• People who are reasonably well and able to carry out daily activities, based on a standard medical rating scale (ECOG score of 0, 1, or 2).
• People whose kidneys are functioning at an adequate level, as measured by a specific blood test calculation.
• People living with HIV may be eligible if their immune cell count (CD4) is at or above a certain level, their virus levels are very low, they have not had serious HIV-related complications in the past year, they are being treated and monitored by an HIV specialist, their HIV treatment has been stable for at least 4 weeks, and they have tested negative for tuberculosis (or have completed tuberculosis preventive treatment if they tested positive).
• People whose tumor size has been physically measured by a doctor within the 4 weeks before joining the trial.
• People who have had specific imaging scans — including a PET scan and either a contrast CT or MRI of the abdomen/pelvis — to assess the extent of the cancer.
• People who have not previously received chemotherapy for anal cancer.
• People who have not had major surgery (such as removal of the rectum and anus) as a treatment attempt for anal cancer, though people who had a smaller local removal procedure may still be considered (confirm with trial site).
• People who are not currently receiving any other cancer treatment or taking part in another experimental treatment study.
• People who do not have serious ongoing illness, active infection, or mental health or social circumstances that a doctor believes would make it difficult to follow the trial requirements.
• People who have not had a serious heart or blood vessel event (such as a heart attack, stroke, or uncontrolled heart rhythm problem) in the 6 months before joining, unless it has been treated and is considered well controlled by the treating doctors.
• People with a history of another cancer may be considered eligible if the treating doctor believes the risk of that cancer returning is low.
• People on a blood-thinning medication called warfarin within 2 weeks before joining will need to switch to a different blood thinner if they are to receive one of the chemotherapy medicines (capecitabine); otherwise, a different form of chemotherapy will be used (confirm with trial site).
• People whose blood counts and organ function fall within acceptable ranges, including: haemoglobin, platelet count, white blood cell count, liver function markers, bilirubin levels, and albumin — all within ranges specified by the trial. People with a condition called Gilbert's disease may still be considered at the treating doctor's discretion.
• People who are not pregnant and not breastfeeding. People who could become pregnant and sexually active males must agree to use effective contraception during the trial and for at least 6 months after treatment ends.
• People who are able to understand the trial and are willing to sign a written consent form.
• People who have been tested for a genetic enzyme difference called DPYD deficiency, and who are not found to carry two copies of this genetic variant (homozygous).

Who may not be able to join:

• People who have previously had radiation therapy to the pelvic area, or any prior radiation that would overlap with the radiation planned in this trial.
• People who have had an allergic reaction to medicines similar to capecitabine (one of the chemotherapy drugs used in the trial).
• People with another current or past cancer whose history or treatment could interfere with how the trial measures safety or effectiveness, in the opinion of the treating doctor.
• People with inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), scleroderma, or who carry two copies of the DPYD gene variant (homozygous DPYD deficiency).
• People who have a fistula (an abnormal channel or connection) between the tumour and another organ.
• People who have an active autoimmune disease or inflammatory bowel disease that has needed systemic (whole-body) medical treatment at any point in the past 2 years.
• People who have previously been treated with certain immunotherapy medicines known as immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA4 drugs).
• People with a condition that weakens the immune system, or who have been taking steroid medicines (at a dose equivalent to more than 10 mg of prednisone per day) or other immune-suppressing medicines within 7 days before the first dose. Low-dose topical or occasional inhaled steroids are generally permitted.
• People who have received a live vaccine within 30 days before the first dose of trial treatment. Certain vaccines such as the injected seasonal flu vaccine are generally allowed, but nasal spray flu vaccines and others listed (e.g., measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, oral typhoid) are not.
• People with a known lung condition called interstitial lung disease that causes symptoms or could make it difficult to detect or manage potential lung side effects from the trial medicines.
• People who have had an allergic reaction to medicines that are similar in chemical or biological makeup to retifanlimab (one of the immunotherapy drugs used in the trial).
• People confirmed to carry two copies of the DPYD gene variant (homozygous for dihydropyrimidine dehydrogenase deficiency).

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