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 given written consent before any study procedures begin.
• People aged 18 to 75 years at the time of joining the trial.
• People whose rectal cancer has been confirmed by a tissue biopsy as a specific type called adenocarcinoma.
• People whose tumor is located within 10 cm of the opening of the back passage, as shown by a camera examination or scan.
• People with locally advanced rectal cancer at a specific stage, confirmed by an MRI scan of the pelvis (confirm with trial site for exact staging details).
• People whose tumor has a specific biological profile — described as "mismatch repair proficient" or "microsatellite stable" — confirmed by laboratory testing.
• People with no sign of cancer having spread to other parts of the body, based on CT scans of the chest, abdomen, and pelvis.
• People whose MRI scan shows the tumor is not too close to a specific surgical boundary (called the circumferential resection margin) and is not growing into the surrounding tissue layer.
• People who are generally well and able to carry out daily activities, based on a standard medical fitness scale scored at 0 or 1.
• People whose blood tests show the bone marrow, liver, kidneys, and thyroid are all functioning within acceptable levels.
• Women who could become pregnant must have a negative pregnancy test and agree to use effective contraception during the trial and for a set period after the last dose.
• Men whose partners could become pregnant must agree to use effective contraception during the trial and for a set period after the last dose.

Who may not be able to join:

• People whose tumor has grown into nearby organs or structures, as shown on baseline imaging.
• People whose MRI scan shows the tumor is too close to or has grown into the mesorectal fascia (a tissue layer surrounding the rectum).
• People whose cancer has spread to areas outside the pelvis.
• People who have previously had radiotherapy to the pelvis or abdomen.
• People who have previously received immune checkpoint inhibitor therapy or any other systemic cancer treatment for rectal cancer.
• People with an active autoimmune disease, or a history of one that required ongoing medical treatment (some lower-risk conditions may be acceptable — confirm with trial site).
• People currently taking immune-suppressing medications, including steroids at a dose higher than the equivalent of 10 mg per day of prednisone, within two weeks before joining.
• People with a known HIV infection.
• People with active hepatitis B or hepatitis C infections requiring treatment.
• People with an uncontrolled active infection or another serious medical condition that the trial doctor believes would affect safety or the ability to participate.
• People who have had another cancer within the past 5 years, with some exceptions for certain low-risk or fully treated skin or cervical conditions (confirm with trial site).
• People with a known allergy or sensitivity to any of the study medications (pucotenlimab, oxaliplatin, or capecitabine) or their ingredients.
• Women who are pregnant or breastfeeding.
• People who, in the trial doctor's opinion, have any condition that makes participation unsuitable.

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