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 chosen to take part voluntarily, are willing to sign a consent form, and are able to attend follow-up appointments
• People aged 18 to 80 years (inclusive), of any gender
• People who have been diagnosed with locally advanced rectal cancer (a specific type called adenocarcinoma), confirmed by tissue sample and MRI scan, meeting certain staging criteria (confirm with trial site)
• People whose tumour is located within 10 cm of the opening of the back passage, as confirmed by MRI
• People who have not previously received any anti-cancer treatment for rectal cancer (traditional Chinese herbal medicine treatments are an exception)
• People with a general health and activity level rated as 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light work)
• People whose blood counts, liver, kidney, and clotting function all fall within acceptable ranges on tests taken within the two weeks before starting the trial, without having needed blood transfusions or growth factor medications to achieve those results (confirm specific values with trial site)
• Women who could become pregnant must agree to use reliable contraception or avoid heterosexual intercourse from signing the consent form until at least 6 months after the last dose, must have a negative pregnancy blood test within 7 days before starting treatment, and must not be breastfeeding
• Men with a partner who could become pregnant must agree to use reliable contraception or avoid intercourse from signing the consent form until at least 6 months after the last dose, and must also agree not to donate sperm during that time; men with pregnant partners must use a condom

Who may not be able to join:

• People whose rectal cancer has come back after previous treatment
• People whose cancer has been assessed as unable to be removed by surgery, or who are considered unable to tolerate surgery
• People for whom clinical assessment or scans show the cancer has spread to distant parts of the body, or that certain nearby lymph nodes are affected
• People who have more than one colorectal cancer tumour
• People for whom clinical or scan findings suggest a bowel blockage or a tear in the bowel, or where the doctor considers there to be a high risk of such complications
• People for whom the doctor considers long-course radiotherapy to be unsuitable for any reason
• People who have had a stroke, mini-stroke, heart attack, or significant blood vessel disease within the 6 months before joining; or people with poorly controlled heart conditions such as unstable chest pain, moderate-to-severe heart failure, reduced heart pumping function, or serious irregular heartbeat not controlled by medication
• People with a history of active tuberculosis detected in the past year, or a history of tuberculosis more than a year ago that was not properly treated
• People who have had major surgery (performed under general anaesthetic) within the 3 months before starting treatment, or who have wounds that are not healing, active stomach or intestinal ulcers, or untreated bone fractures
• People who have difficulty swallowing or other issues that would prevent them from taking oral (swallowed) medication
• People for whom MRI scans are not medically safe
• People with an active autoimmune disease or a history of certain autoimmune conditions (some exceptions may apply for specific well-controlled conditions — confirm with trial site)
• People with a history of immune system deficiency, a positive HIV test, other immune system disorders, or a history of organ or bone marrow transplant
• People who have had a serious infection within 4 weeks before starting treatment, or who have signs of active infection requiring antibiotics within 2 weeks before starting (unless antibiotics are being used only as a preventive measure)
• People who have a current or past history of certain lung conditions affecting the lung tissue, active lung inflammation seen on a scan, or severely reduced lung function
• People with active hepatitis B or active hepatitis C, or a combined hepatitis B and C infection, based on specific blood test results (confirm with trial site)
• People diagnosed with another cancer within the 5 years before starting the trial (some exceptions may apply for certain treated skin or cervical cancers — confirm with trial site; people who previously received immunotherapy, chemotherapy, targeted therapy, or radiation therapy for another cancer cannot be included)
• People with a known allergy or sensitivity to any of the study drugs (pucotenlimab, oxaliplatin, or capecitabine) or their ingredients
• People who have used immune-suppressing medications or corticosteroids above a certain dose within the 14 days before starting treatment (some lower-dose or topical uses may be permitted — confirm with trial site)
• People who have participated in another clinical trial within 4 weeks before starting this trial
• People with certain uncorrectable abnormalities in sodium, potassium, or calcium blood levels within 2 weeks before starting treatment
• People who have received a live vaccine within 28 days before starting treatment, or who plan to receive one during the treatment period or within 60 days after the last dose
• Women who are pregnant or breastfeeding
• People with other conditions the doctor considers may affect the safety of participation or the reliability of the trial results, such as alcohol or drug misuse, serious mental health conditions, or significant social circumstances (confirm with trial site)

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