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:

• Adults between 18 and 75 years of age
• People who are generally well enough to carry out light activity and care for themselves (a measure doctors use called ECOG score 0–1)
• People who have been diagnosed with rectal cancer (a specific type called adenocarcinoma) confirmed by a tissue test, where the tumour is located in the middle or lower part of the rectum (within 10 cm of the anal opening), and the cancer is at a stage that has not spread to distant parts of the body (stage II or III based on a standard cancer staging system)
• People who have not needed emergency surgery because of complications from their rectal cancer (such as bleeding, blockage, or a perforation)
• People whose cancer has tested negative for a genetic marker called microsatellite instability (described as MSS on testing)
• People who have not yet received any cancer treatment
• People whose cancer has not spread to other parts of the body
• People who have at least one area of cancer that can be measured or assessed on scans or by a doctor
• People whose organs (such as the liver and kidneys) and bone marrow are functioning well enough, as confirmed by blood tests
• People of childbearing potential (both female participants and male participants whose partners could become pregnant) who agree to use effective contraception throughout the treatment period and for 6 months after treatment ends

Who may not be able to join:

• People whose rectal cancer has come back after a previous treatment (recurrent cancer)
• People who have previously received pelvic radiotherapy, rectal cancer surgery, chemotherapy, targeted therapy, or immune-based treatments (such as PD-1, PD-L1, or CTLA-4 inhibitors)
• People who are unable to receive radiotherapy, or who have a known allergy to the study drugs (Penpulimab, capecitabine, oxaliplatin) or their ingredients
• People who have a bowel blockage caused by the tumour, unless a stoma (a surgically created opening for waste) has already been put in place
• People who have had another type of cancer, unless it has been fully cleared for at least 2 years before joining and needs no further treatment during the study — certain exceptions apply, such as some treated skin cancers or pre-cancerous conditions with no signs of return (confirm with trial site)
• People with an active autoimmune disease (where the immune system attacks the body), or a history of one within the past 2 years — some exceptions may apply for certain mild conditions such as vitiligo, controlled thyroid conditions, or type 1 diabetes managed with insulin only (confirm with trial site)
• People who have had any of the following in the 6 months before treatment starts: a heart attack, severe chest pain (unstable angina), heart bypass surgery, significant heart failure, a stroke, a mini-stroke (TIA), a serious heart rhythm problem requiring medication, or a blood clot in the lungs
• People who have had an organ transplant or a bone marrow/stem cell transplant from a donor
• People with poorly controlled or serious ongoing health conditions, including HIV infection or a serious active infection
• People who are pregnant or breastfeeding
• People who have taken part in another clinical drug trial within the past 4 weeks
• People with active hepatitis B or hepatitis C infections, confirmed by specific blood test results
• People who have received a live vaccine within 4 weeks before joining, or who plan to receive one during the study
• People who have had major surgery within 4 weeks before joining
• People with a history of a lung condition called interstitial pneumonia
• People with other significant physical or mental health conditions, or abnormal test results, that in the opinion of the research team could increase health risks or affect the study results

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