Phase 3 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 diagnosed with colorectal cancer (specifically adenocarcinoma) that has spread or cannot be surgically removed, confirmed by tissue or cell testing.
• People whose cancer has been tested and confirmed to be of a specific type called "pMMR/MSS or MSI-L," meaning the cancer cells have normal DNA repair proteins (tested by PCR or a special protein stain).
• People whose cancer got worse during or after a first round of treatment containing a chemotherapy drug called oxaliplatin, or who had to stop that treatment due to side effects; or people whose cancer came back within 180 days of finishing oxaliplatin-based therapy after surgery.
• People who have at least one area of cancer that can be measured on a scan, according to standard medical measurement guidelines.
• People with a general health and activity level rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People who are willing and able to sign a consent form and follow the trial's visit schedule and procedures.
• People aged 18 to 75 years old.
• People whose doctors expect them to survive for at least 18 weeks.
• People who are able and willing to use effective contraception throughout treatment and for 6 months after — this applies to women who could become pregnant, and to men whose partners could become pregnant.
• People whose blood test results from within 7 days before joining the trial meet specific levels for blood cell counts, liver function, kidney function, urine protein, and blood clotting (no corrective treatments such as blood products or growth factors are allowed in the 14 days before those tests are taken).

Who may not be able to join:

• People who have previously received certain types of cancer treatments, specifically anti-PD-1 or anti-PD-L1 immunotherapy drugs, HDAC inhibitor drugs, or the chemotherapy drug irinotecan.
• People who have taken part in another clinical trial involving an experimental treatment within the 4 weeks before starting this trial.
• People currently enrolled in another interventional (treatment-based) clinical trial, unless it is an observation-only study or a follow-up phase.
• People who received any anti-cancer treatment (chemotherapy, targeted therapy, immunotherapy, or tumour embolisation) within 3 weeks before starting this trial.
• People who received radiotherapy within 4 weeks before starting this trial.
• People who received radiotherapy more than 4 weeks ago but still have ongoing side effects from it, such as lung, liver, or bowel inflammation from radiation.
• People who used immune-suppressing medications within the 4 weeks before starting the trial (with some exceptions for low-dose or locally applied steroids).
• People who received a live vaccine within 4 weeks before starting the trial, or who plan to receive one during the study.
• People who had major surgery or who have wounds, ulcers, or fractures that have not fully healed within 4 weeks before starting the trial.
• People who still have significant side effects (above a mild level) from previous cancer treatments, with the exception of hair loss or minor abnormal lab results without symptoms.
• People with brain metastases that are currently causing symptoms, or cancer that has spread to the membranes around the brain; people with previously treated brain metastases may be considered if the cancer in the brain has been stable for at least 4 weeks and symptoms have reduced to a mild level (confirm with trial site).
• People who have had an active autoimmune disease requiring ongoing systemic medical treatment within the past 2 years; some replacement therapies such as thyroid hormone or insulin are allowed.
• People with a known history of a primary immune deficiency condition.
• People known to have active tuberculosis or who have been treated for tuberculosis within the past year.
• People known to have interstitial lung disease that requires steroid treatment.
• People with active hepatitis B or hepatitis C infection, based on specific blood test levels (confirm with trial site).
• People known to be infected with HIV or syphilis.
• People with severe or poorly controlled active infections, including serious infections requiring hospitalisation within the past 4 weeks.
• People with significant malnutrition requiring intravenous nutritional support, unless this was corrected more than 4 weeks before joining.
• People with symptomatic heart failure or poorly controlled heart rhythm problems.
• People with uncontrolled high blood pressure (blood pressure at or above 150/100 mmHg) even with standard treatment.
• People who had a serious blood clot event in an artery — such as a heart attack, pulmonary embolism, or unstable chest pain — within the 6 months before joining.
• People who had a serious deep vein blood clot or similar event within the 3 months before joining (minor clots related to IV lines or surface veins are not included in this restriction).
• People with serious liver disease affecting brain function or kidney function, or with moderate to severe cirrhosis (Child-Pugh class B or worse).
• People with a history of a hole or abnormal opening in the gastrointestinal tract in the past 6 months, or a history of peptic ulcers, bowel obstruction, major bowel removal surgery with ongoing diarrhoea, Crohn's disease, ulcerative colitis, abdominal abscess, or long-term chronic diarrhoea; or people who have had an intestinal stent placed.
• People who are having more than 3 loose stools per day at the time of joining, suggesting ongoing uncontrolled bowel symptoms.
• People known to be allergic or intolerant to atropine sulfate, loperamide, or anti-nausea medications used alongside a specific chemotherapy regimen called FOLFIRI.
• People with uncontrolled metabolic conditions or other serious non-cancer diseases that could increase health risks or make it harder to evaluate survival.
• People with a known inherited disorder affecting bleeding or blood clotting.
• People who had a serious, life-threatening bleeding event within the past 3 months requiring transfusion, surgery, or ongoing medication.
• People considered by the trial doctors to be at high risk of bleeding — for example, due to severe varicose veins in the oesophagus from liver disease, or recurring bleeding events.
• People who had a stroke or mini-stroke (transient ischaemic attack) within the past 6 months.
• People who have taken high-dose aspirin (more than 325 mg per day) or certain anti-inflammatory pain medications for 10 or more consecutive days within the 10 days before starting the trial.
• People who have taken blood-thinning or clot-dissolving medications for 10 or more consecutive days within the 10 days before starting the trial (preventive/low-dose anticoagulant use is allowed).
• People who have fluid build-up around the lungs, in the abdomen, or around the heart that is causing symptoms or needs to be drained; small amounts of fluid visible only on imaging and causing no symptoms may be acceptable (confirm with trial site).
• People with a history of another cancer, with some exceptions: cancers in full remission for at least 2 years with no ongoing treatment needed; treated non-melanoma skin cancers with no sign of return; or treated non-invasive cancers (carcinoma in situ) with no sign of return.
• People who have had an organ transplant or bone marrow/stem cell transplant from a donor.
• People known to be allergic to any component of the monoclonal antibody treatment used in this trial.
• People who are pregnant or breastfeeding.
• People with a history of alcohol or drug abuse.
• People with other serious medical conditions, psychiatric disorders, or abnormal lab results that the trial doctor believes would make participation unsafe or affect the reliability of the results.

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