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 to take part and are able to attend the required visits and follow the study procedures.
• People aged between 18 and 75 years.
• People who have been diagnosed with primary rectal cancer (a specific type called adenocarcinoma), confirmed by tissue testing, with the tumour located within 10cm of the anal opening as shown on MRI scan.
• People whose rectal cancer has spread to a limited number of other sites in the body (no more than 2 separate areas and no more than 5 individual spots in total), confirmed by detailed imaging scans.
• People whose cancer has been tested and confirmed to have a specific genetic characteristic called MSS (microsatellite stable) or pMMR (proficient mismatch repair), meaning the cancer cells have normal DNA repair function.
• People who have at least one area of cancer that can be measured on imaging scans according to standard research guidelines (RECIST v1.1).
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard health scale used in cancer research (ECOG performance status).
• People whose blood counts meet minimum levels: white blood cells (neutrophils) at 1.5×10⁹/L or above, platelets at 100×10⁹/L or above, and haemoglobin at 10.0 g/dL or above.
• People whose liver function tests are within acceptable ranges, including bilirubin, liver enzymes (ALT and AST), and blood protein (albumin) levels as defined by the trial.
• People whose kidneys are working well enough, based on blood and urine tests showing creatinine and protein levels within acceptable limits.
• People whose blood clotting tests (INR and APTT) are within acceptable ranges, and who are able to switch certain blood-thinning medications before surgery if needed.
• People who do not have any serious non-cancer illness expected to significantly shorten their life expectancy.
• Women who could become pregnant must use effective contraception throughout treatment and for 6 months after finishing, and must have a negative pregnancy test before starting. Men whose partners could become pregnant must also use effective contraception during this period.

Who may not be able to join:

• People whose cancer has spread to more than 2 separate areas or more than 5 individual spots in total, as confirmed by imaging.
• People who have already received any treatment for this rectal cancer, including surgery, radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
• People who have previously been treated with certain types of immunotherapy drugs that work on immune system checkpoints (such as anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 drugs), or cell-based immunotherapy.
• People currently taking part in another interventional clinical trial (observational studies or follow-up studies are generally excepted — confirm with trial site).
• People who have received any experimental drug within 4 weeks before the first dose of the study treatment.
• People who have had a blood transfusion or received certain blood cell–stimulating medications (G-CSF, GM-CSF, EPO, TPO, or IL-11) within 14 days before screening blood tests.
• People who have used immune-suppressing medications in the 4 weeks before starting the study, with some specific exceptions such as low-dose steroid creams, inhalers, or pre-medication for allergies (confirm with trial site).
• People who have used certain traditional Chinese medicines with anti-tumour or immune-modifying effects within 1 week before the first dose.
• People who have received live or weakened vaccines within 4 weeks before the first dose, or who expect to receive such vaccines during the study.
• People who have had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before the first dose, or who have wounds, ulcers, or fractures that have not yet healed.
• People with an active or recent (within the past 2 years) autoimmune disease, with some exceptions for mild conditions that do not require ongoing systemic treatment (confirm with trial site).
• People with a known history of a primary immune system deficiency condition.
• People with active tuberculosis, currently receiving TB treatment, or who received TB treatment within the past year.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People with a known allergy to any of the study drugs: capecitabine, oxaliplatin, serplulimab, or related antibody components.
• People with significant fluid build-up in the abdomen, around the lungs, or around the heart that requires medical intervention.
• People who are HIV positive.
• People with active hepatitis B or hepatitis C infection, as defined by specific blood test results.
• People with an active syphilis infection that requires treatment.
• People who have had a severe infection within 4 weeks before the first dose, including infections requiring hospitalisation, or who have taken antibiotic tablets or intravenous antibiotics within 2 weeks before the first dose.
• People with significant heart problems, including heart failure (NYHA class II–IV), a weakened heart pump (LVEF below 50%), uncontrolled irregular heartbeat, a condition called long QT syndrome, or an abnormal heart rhythm reading on ECG.
• People with uncontrolled high blood pressure (blood pressure at or above 160/100 mmHg despite medication), or a history of hypertensive crisis or related brain complications.
• People with serious blood clotting disorders or who are currently receiving clot-dissolving treatment.
• People who have had a serious arterial blood clot event within 6 months before the first dose, such as a heart attack, severe chest pain (unstable angina), stroke, or mini-stroke (TIA).
• People with high-risk varicose veins in the oesophagus or stomach that may need urgent treatment, or those at high bleeding risk who have not had an endoscopy within 3 months before enrolment.
• People with a history of a hole (perforation) or abnormal channel (fistula) in the digestive tract within the past 6 months.
• People who have had a life-threatening bleeding event within 3 months before the first dose, or serious digestive or variceal bleeding requiring transfusion, endoscopy, or surgery.
• People who have had a serious blood clot in a vein (such as a deep vein thrombosis or pulmonary embolism) within 3 months before the first dose (some minor clot types may be excepted — confirm with trial site).
• People with uncontrolled metabolic conditions or other serious non-cancer illnesses that pose high medical risk.
• People with serious liver disease, including hepatic encephalopathy, hepatorenal syndrome, or advanced cirrhosis.
• People with a blocked bowel, conditions that increase the risk of bowel perforation, or a history of significant bowel surgery, Crohn's disease, ulcerative colitis, or ongoing chronic diarrhoea.
• People with active lung inflammation (interstitial lung disease) requiring treatment, or a history of significant lung scarring or severe lung dysfunction.
• People with significant malnutrition (defined as notable unintentional weight loss or severely reduced food intake in recent weeks or months), unless this has been corrected for at least 4 weeks before the first dose.
• People with a history of another cancer, unless it was fully treated at least 2 years ago with a low chance of return, or was a type of skin cancer or pre-cancerous condition that has been fully treated (confirm with trial site).
• People with other serious ongoing medical, neurological, psychiatric, or social conditions that the trial team considers would make participation unsafe or affect the reliability of results.
• People with significant alcohol, drug, or substance use that could affect how the study drugs work or how side effects are assessed.
• People who are pregnant or breastfeeding.

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