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:

• Adults between 18 and 75 years old at the time of signing the consent form
• People with stomach cancer (gastric cancer) or cancer at the junction of the stomach and oesophagus that cannot be removed by surgery and has either spread to nearby areas or to other parts of the body, confirmed by imaging and tissue testing as a type called adenocarcinoma, with at least one measurable tumour
• People who have not yet received systemic (whole-body) treatment for advanced or metastatic stomach cancer; those who previously had chemotherapy or radiation aimed at curing the disease may be considered if their cancer came back at least 6 months after that treatment ended
• People whose cancer tests negative for a protein called HER2
• People whose stomach cancer has spread to the lining of the abdomen (peritoneal metastasis), including those with fluid build-up confirmed by imaging or testing
• People with an expected survival of more than 3 months
• People with a general health/activity level score of 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work) (confirm with trial site)
• People whose side effects from any previous cancer treatment or surgery have mostly resolved to mild or no symptoms
• People with adequate blood counts, liver function, kidney function, urine results, and normal blood clotting, without needing blood transfusions or growth factor support in the 7 days before the first dose (confirm with trial site for specific values)
• Women of childbearing age who have a negative pregnancy test before starting treatment, and who — along with male participants whose partners could become pregnant — agree to use effective contraception during treatment and for 6 months after the last dose
• People who are willing and able to attend scheduled visits, complete required tests, and follow the study procedures

Who may not be able to join:

• People whose stomach cancer is a type other than adenocarcinoma (such as squamous cell carcinoma or undifferentiated cancer), or adenocarcinoma mixed with other cancer types
• People whose stomach cancer tests positive for HER2
• People who have previously been treated with immune checkpoint inhibitors (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs), immune-activating antibodies, immune cell therapies, or any other treatment targeting the immune system for cancer
• People who had uncontrolled fluid build-up around the lungs or in the abdomen that could not be managed by drainage in the 14 days before joining the trial (a small-to-moderate amount visible on imaging may still be considered)
• People who have had significant bleeding, such as gastrointestinal bleeding or bleeding stomach ulcers, in the month before the first dose
• People with currently active coughing up of blood, active bowel pouches infection (diverticulitis), abdominal abscess, or bowel blockage
• People diagnosed with another cancer in the past 5 years, except for certain fully treated skin cancers, superficial bladder cancer, cervical cancer confined to the surface layer, certain breast duct cancers, or papillary thyroid cancer, with clear medical records confirming cure
• People with active or untreated cancer that has spread to the brain or spinal cord coverings, unless the brain metastases have been treated, have been stable on imaging for at least 4 weeks, and steroid or anti-seizure medications have been stopped for at least 2 weeks, and there are measurable tumours outside the brain
• People with known interstitial lung disease, non-infectious lung inflammation, uncontrolled conditions such as diabetes, high blood pressure, or lung scarring, active pneumonia, or a history of active tuberculosis
• People with active autoimmune disease requiring ongoing systemic treatment (some stable autoimmune conditions that do not need immune-suppressing treatment, such as controlled type 1 diabetes or hypothyroidism on hormone replacement only, may still be considered)
• People with poorly controlled heart conditions, including significant heart failure, severe or unstable chest pain (angina), a heart attack within the past 6 months, certain serious heart rhythm problems, symptomatic heart failure, or an abnormal heart electrical reading (QTc over 480 ms)
• People who have had major surgery in the 28 days before starting the trial
• People who have used immune-suppressing medications in the 14 days before starting (low-dose steroids at physiological levels may be acceptable — confirm with trial site)
• People who have received a live vaccine in the 28 days before starting or who plan to receive one within 60 days after treatment ends
• People who received local cancer treatments such as radiotherapy or tumour embolisation in the 28 days before starting
• People who used herbal or traditional medicine products with anti-tumour indications in the 2 weeks before starting
• People with a known allergy or intolerance to the study drugs or their ingredients, or a history of severe allergic reactions to similar antibody-based medicines
• People who cannot swallow, have malabsorption conditions, or have uncontrolled nausea, vomiting, diarrhoea, or other gut problems that would seriously affect how the medication is absorbed
• People with HIV infection or AIDS, or active hepatitis B or C infection as defined by specific blood test levels (confirm with trial site)
• People who are unable or unwilling to follow the trial schedule or attend follow-up appointments
• People whom the trial investigators believe may face additional risks from the study treatment or whose participation could make it difficult to assess results accurately

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