Phase 2 Stomach 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 signed a dated written consent form before any study-related procedures begin
• People who are willing and able to attend scheduled visits, follow the treatment plan, and complete required tests
• People diagnosed with inoperable, advanced, or metastatic stomach cancer, cancer at the junction of the stomach and oesophagus, or lower oesophageal cancer, confirmed by tissue testing to be mainly adenocarcinoma (a specific cancer type)
• People whose tumour tests show a PD-L1 combined positive score (CPS) of 5 or higher — a measure of a protein on tumour cells that can affect how the immune system responds
• People who have not yet received systemic (whole-body) cancer treatment for advanced or metastatic disease; if prior chemotherapy was given before or after surgery, it must have been completed at least 6 months before the cancer was found to have spread or returned
• People who have at least one tumour that can be measured on a CT scan or MRI scan, with scan results obtained within 28 days before joining the study
• People whose general physical functioning is rated 0 or 1 on the ECOG scale — meaning they are either fully active or have some limits on heavy physical activity but can do light work (confirm with trial site)
• People whose recent blood tests (taken within 14 days before joining) show that blood cell counts, kidney function, liver function, and mineral levels such as potassium, magnesium, and calcium are all within acceptable ranges as defined by the trial
• People whose heart electrical activity test (ECG) shows a corrected QT interval of 450 milliseconds or less for males, and 470 milliseconds or less for females — a measure of heart rhythm (confirm with trial site)
• People who can provide a tumour tissue sample (either a tissue block or a minimum of 20 slides) from the primary or a secondary cancer site for central laboratory testing
• People enrolled in a national health insurance or healthcare system
• People aged 18 years or older
• Women who are not pregnant, not breastfeeding, and not planning to become pregnant during the study
• Women of childbearing potential who have a negative pregnancy blood test within 72 hours before starting treatment, and who agree to use adequate contraception throughout treatment and for a specified period after the last dose (the length varies depending on which study drug: 5 months for nivolumab, 9 months for oxaliplatin, 6 months for 5-FU, or at least 1 month for EXL01)
• Fertile males who are sexually active with women of childbearing potential and who agree to use contraception during treatment and for 6 months after the last dose of nivolumab, oxaliplatin, or 5-FU, or at least 1 month after the last dose of EXL01, and who agree not to donate sperm during this time

Who may not be able to join:

• People whose cancer is known to be HER-2 positive, or where HER-2 status is not known before joining
• People with active cancer that has spread to the brain, or a known history of cancer spreading along the lining of the brain and spinal cord
• People with uncontrolled fluid build-up in the abdomen (ascites) that cannot be managed with appropriate treatment
• People who have had another active cancer in the past 3 years, except for certain localised cancers that appear to have been fully treated, such as some skin cancers or early-stage cancers of the bladder, prostate, cervix, or breast
• People with active or suspected autoimmune disease (conditions where the immune system attacks the body), with certain exceptions such as well-controlled type 1 diabetes, thyroid conditions requiring only hormone replacement, or skin conditions not needing systemic treatment
• People with symptomatic lung disease affecting the air spaces in the lungs (interstitial lung disease) that could interfere with detecting or managing possible treatment side effects
• People who have previously been treated with certain immune checkpoint or T-cell targeting therapies, including anti-PD-1, anti-PD-L1, anti-LAG-3, or anti-CTLA-4 drugs, anti-tumour vaccines, or similar treatments
• People currently taking corticosteroids at doses greater than 10 mg per day of prednisone equivalent, or other immune-suppressing medications, within 14 days before joining (certain low-dose or inhaled steroids may be permitted — confirm with trial site)
• People who still have side effects of grade 2 or higher from previous cancer treatments at the time of joining
• People who have had major surgery within 28 days before the first study treatment dose, or who have not yet fully recovered from earlier surgery
• People receiving any other cancer treatment at the same time as this trial
• People who have difficulty swallowing, poor oral intake, a blockage in the digestive tract, or who cannot take tablets or capsules by mouth; feeding tubes through the nose are not permitted
• People with a known condition that prevents proper absorption of food or medication through the gut
• People who are currently participating in, or have participated in, another clinical trial involving an experimental drug within 28 days before the first study treatment dose (those in a follow-up phase may be eligible if at least 3 months have passed since the last dose — confirm with trial site)
• People who have had a bone marrow transplant from a donor, or a solid organ transplant (such as a kidney or liver transplant)
• People who have had a faecal microbiota transplant (a procedure involving transfer of gut bacteria from a donor) within 3 months before screening
• People currently taking probiotic supplements, or who plan to take them during the study
• People who drink more than 1 alcoholic drink per day (women) or more than 2 alcoholic drinks per day (men)
• People with a known allergy or sensitivity to nivolumab, EXL01, any other live probiotic product, or soy-based products
• People with a known or newly diagnosed parasitic infection of the gut within 3 months before screening
• People with active inflammatory bowel conditions such as Crohn's disease, ulcerative colitis, or coeliac disease, or any serious ongoing intestinal condition with uncontrolled diarrhoea
• People with active or chronic hepatitis B (with some exceptions based on specific test results and treatment — confirm with trial site), active hepatitis C (with some exceptions — confirm with trial site), or HIV infection
• People who have received a live vaccine within 28 days before joining, or who would need a live vaccine during the study (examples include vaccines for yellow fever, chickenpox, shingles, measles, mumps, rubella, tuberculosis, rotavirus, and some flu vaccines)
• People currently taking the antiviral medicine sorivudine or closely related drugs such as brivudine
• People with a condition called DPD deficiency, identified by a uracil blood level above 16 ng/mL — this affects how the body processes certain chemotherapy drugs; test results must be available before joining
• People with any condition that, in the trial doctor's judgement, would affect how the study treatments are evaluated or affect the safety of participation
• People with known nerve damage in the hands or feet (peripheral sensory neuropathy) that affects daily function, prior to starting treatment
• People with known serious active infections that could interact with the chemotherapy used in this trial
• People with significant active heart disease or who have had a heart attack within the past 6 months
• People with a known allergy to 5-FU, oxaliplatin, or leucovorin, or any of their ingredients
• People who are unable to attend regular medical follow-up due to geographical, social, or mental health reasons
• People who are legally unable to give consent, or who are under a legal guardianship or protection order

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