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 who have been diagnosed with rectal cancer (adenocarcinoma) confirmed by a laboratory tissue test
• People whose cancer has a specific genetic feature called dMMR or MSI-H (a marker found through tumour testing), whether or not they have Lynch syndrome
• People who have not previously received any treatment for this rectal cancer (people with Lynch syndrome must not have received any anti-cancer treatment for this specific rectal cancer diagnosis)
• People whose cancer has not spread to distant parts of the body (apart from certain nearby lymph nodes), whose tumour is within 15cm of the anus, and whose cancer is at a certain stage based on pelvic MRI scan results
• People aged 18 or older
• People who are generally well enough to carry out daily activities, based on a standard medical fitness scale (score of 0 or 1 on the ECOG scale — confirm with trial site)
• People whose blood counts, liver, kidney, thyroid, and heart function all fall within acceptable ranges as measured by blood and other tests
• People who have not received blood transfusions, blood products, or certain blood-stimulating medications in the two weeks before joining
• People who have signed a consent form agreeing to take part
• People with a life expectancy of at least 3 months

Who may not be able to join:

• People with a history of serious allergic diseases, or a known severe allergy to antibody-based medicines or the study drug Sintilimab
• People who have had another cancer in the past 5 years, unless it was certain types that were fully treated (such as early-stage cervical cancer, skin basal cell carcinoma, or certain gastrointestinal cancers removed by endoscopy)
• People with a current or past history of autoimmune conditions (where the immune system attacks the body), including but not limited to lung inflammation, eye inflammation, bowel inflammation, active hepatitis B (at certain levels despite treatment), kidney inflammation, or thyroid disorders
• People who have used medications that suppress the immune system, including steroids, in the two weeks before joining
• People who have a serious active infection currently requiring intravenous (drip) antibiotics, antifungal, or antiviral medications
• People with an immune system condition present from birth or developed over time (such as HIV infection), or active hepatitis B at certain levels despite regular antiviral treatment
• People who have any of the following serious health complications: major bowel bleeding, a hole or blockage in the bowel, certain heart conditions (such as unstable chest pain, heart attack, or heart failure), diabetes or high blood pressure that cannot be controlled, or severe uncontrollable diarrhoea
• People with a tendency to bleed, or who are currently taking blood-thinning or clot-dissolving medications
• People who are pregnant or breastfeeding, or people (male or female) who are not willing to use any form of contraception during the trial
• People with psychiatric conditions that would make it difficult to follow the trial requirements
• People whom the trial doctors consider unsuitable for the study for any other reason

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