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 are 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with advanced or returning colorectal cancer (CRC) that has been confirmed by laboratory tissue testing, has at least one measurable area of disease, and has been identified by specific laboratory tests as a type called pMMR or non-MSI-H
• People who have already received at least two different courses of treatment for their cancer, which may have included chemotherapy drugs (such as 5-fluorouracil, oxaliplatin, or irinotecan) and may or may not have included targeted or biological treatments
• People who have a stored tumor tissue sample from within the last 5 years available to submit, or who can provide a fresh biopsy sample if a stored sample is not available
• People who are well enough to carry out light activity and care for themselves — rated 0 or 1 on a standard doctor-assessed scale called the ECOG Performance Status
• People whose recent blood test results (taken within 7 days before starting the trial) show that their blood cell counts, liver function, kidney function, protein levels, and clotting are all within the ranges required by the trial (confirm specific values with the trial site)
• People whose side effects from previous cancer treatments have mostly resolved — generally to a mild level or better — before joining, with the exception that mild-to-moderate nerve tingling or numbness from chemotherapy, or hair loss of any degree, may still be present
• People who test negative for Hepatitis B surface antigen, Hepatitis C antibody, and HIV antibody — though people with certain controlled or previously treated Hepatitis B or C infections may still be eligible in some circumstances (confirm with trial site)
• People who are willing and able to use effective contraception during the trial and for a set period after the last dose (at least 90 days for men; at least 180 days for women who could become pregnant)
• Women who are not pregnant and not breastfeeding, and who are either unable to become pregnant (due to surgery or having gone through menopause for at least 12 months) or who agree to use effective contraception as required by the trial
• People who are able to understand and sign the consent form and follow the trial's requirements

Who may not be able to join:

• People who have had cancer spread to the membranes surrounding the brain or spinal cord (leptomeningeal disease)
• People with an active autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions) — though some mild or well-controlled conditions such as autoimmune thyroid disease, controlled Type 1 diabetes, or limited skin conditions like eczema or psoriasis affecting less than 10% of the body surface may still be considered eligible (confirm with trial site)
• People with a history of certain types of lung scarring or inflammation, or who show signs of active lung inflammation on a screening scan — though scarring from previous radiation treatment to the chest may be acceptable (confirm with trial site)
• People with active tuberculosis
• People who have had a significant heart or stroke-related event within the past 3 months, or who have unstable heart rhythm or unstable chest pain; also people with a significantly prolonged heart electrical interval (QTc >450 milliseconds), certain heart rhythm risk factors, or who are taking medications known to affect heart rhythm
• People who have had a major surgical procedure (other than for diagnosis) within 4 weeks before starting the trial, or who expect to need major surgery during the trial
• People who have had another type of cancer within the past 5 years — though some low-risk cancers that were fully treated (such as certain early-stage skin cancers, cervical carcinoma in situ, or early-stage prostate cancer) may still be eligible (confirm with trial site)
• People who have had a serious infection within the 4 weeks before starting the trial, including infections requiring hospitalisation, a blood infection, or severe pneumonia
• People with any other serious medical condition, abnormal test result, or finding that could make the trial treatments unsafe or make it difficult to interpret the results
• People with a history of severe allergic reactions to certain types of antibody-based medicines, or who are known to be allergic to any ingredient in the trial drugs (tislelizumab or bevacizumab), including products derived from Chinese hamster ovary cells
• Women who are currently breastfeeding, who have a positive pregnancy test at screening, or who plan to become pregnant during the trial or within at least 120 days after the last dose
• People whose cancer has spread to the brain or spinal cord and is causing symptoms, has not been treated, or is currently growing — though people with previously treated, stable brain metastases that are not causing symptoms may be eligible in some circumstances (confirm with trial site)
• People with cancer pain that is not well controlled; pain medication must be stable before joining, and certain painful areas should be treated with radiation before enrollment if possible
• People with ongoing fluid build-up around the lungs, heart, or abdomen that needs to be drained more than once a month
• People who have received any other experimental treatment within 28 days before starting the trial
• People who have taken certain medications known to interfere with how the body processes drugs (specific CYP3A4, CYP2C8, CYP2C9, or CYP2C19 enzyme inhibitors, inducers, or sensitive substrates) within 14 days before starting the trial (confirm specific medicines with the trial site)
• People who have previously received certain immunotherapy treatments (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 medicines) and whose cancer continued to grow during or after that treatment
• People who have taken systemic medicines that suppress the immune system (such as steroids, methotrexate, or similar drugs) within 2 weeks before starting the trial, or who are expected to need such medicines during the trial — though a short, one-time dose for a specific reason (such as a contrast dye allergy) may be acceptable with medical approval
• People whose blood pressure is not well controlled (consistently above 150/100 mmHg on multiple readings) — though blood pressure medication to bring levels within range is permitted
• People with a history of a hypertensive emergency or hypertensive brain injury
• People who have had a significant blood vessel problem (such as an aortic aneurysm needing surgery or a recent blood clot in an artery) within the past 6 months
• People who have coughed up more than a small amount of bright red blood (more than 2.5 mL per episode) within the past month
• People with a known bleeding disorder or significant problem with blood clotting (when not on blood-thinning treatment)
• People currently taking high-dose aspirin (more than 325 mg per day) or certain blood-thinning medications (such as clopidogrel, dipyridamole, ticlopidine, or cilostazol) within 10 days before starting the trial
• People currently taking full-dose blood thinners or clot-dissolving medicines for treatment (not prevention) purposes within 10 days before starting — people taking warfarin are not eligible; certain other preventive blood thinners may be allowed (confirm with trial site)
• People who have had a core biopsy or minor surgical procedure (other than placement of a vascular access device such as a port) within 3 days before the first dose
• People who have had a fistula (abnormal connection) in the abdomen or throat, a hole in the gut wall, or an internal abdominal abscess within the past 6 months
• People who have had a bowel blockage, or signs and symptoms of bowel obstruction, within the past 6 months — though people who had this at the time of their original diagnosis and had it surgically resolved may be eligible (confirm with trial site)
• People with unexplained free air in the abdomen (not explained by a recent procedure)
• People with a serious wound that is not healing, an active ulcer, or an untreated bone fracture
• People whose cancer is pressing on or is very close to major airways or blood vessels, or who have a large tumour mass in the central chest area
• People who have had an inflammatory condition in the abdomen (such as peptic ulcer disease, diverticulitis, or colitis) within the past 6 months
• People who have had curative-intent radiation treatment within 28 days before starting, or radiation to the abdomen or pelvis within 60 days before starting — though radiation to bone for pain relief within 7 days may be acceptable
• People who have had major surgery, an open biopsy, or a significant injury within 28 days before starting; or abdominal surgery or significant abdominal injury within 60 days before starting; or who have not fully recovered from such procedures
• People who take anti-inflammatory pain medicines (NSAIDs) every day on an ongoing basis — though occasional use for things like headaches or fever is acceptable
• People who are unable to swallow oral (by mouth) medications, or who have a gut condition that could significantly affect how the oral study drug is absorbed by the body (such as ongoing diarrhoea with poor nutrient absorption)

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