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 aged 18 to 75 years who have been diagnosed with stomach (gastric) cancer or cancer at the junction of the stomach and oesophagus (gastroesophageal junction cancer).
• People whose cancer has been confirmed by endoscopy and tissue testing (pathology) to be a specific type called adenocarcinoma, and which tests negative for a protein called HER-2.
• People whose cancer has been staged as Stage III (a specific level of spread) based on CT scan results, using the AJCC 8th edition staging system.
• People with gastroesophageal junction cancer of a specific subtype (Siewert type II or III), where chest surgery would not be needed.
• People whose cancer has been assessed by a gastrointestinal surgeon and a radiologist as being surgically removable with the aim of no cancer remaining (called R0 resection), and who have agreed to undergo that surgery.
• People who have not previously received any treatment for this cancer, including surgery, chemotherapy, radiotherapy, or immunotherapy.
• People with a life expectancy of at least 3 months.
• People whose cancer can be measured according to standard imaging criteria (RECIST v1.1).
• People who are in good general physical condition, rated 0 or 1 on a standard activity scale (ECOG performance status), measured within 7 days before the first treatment dose.
• People with good heart function suitable for surgery; if there are signs of underlying heart disease, a cardiologist assessment would be required.
• People whose blood test results show that major organs (liver, kidneys, bone marrow, thyroid, and heart) are functioning within acceptable ranges, including adequate blood cell counts, liver enzymes, kidney function, clotting function, and thyroid levels (specific thresholds apply — confirm with trial site).
• People who weigh at least 40 kg or have a body mass index (BMI) above 18.5.
• Women who are past menopause (no periods for at least one year without another medical cause) or who have had surgical removal of the ovaries and/or uterus.
• Women of childbearing potential who have a negative pregnancy test within 7 days before the first dose, and who agree to use highly effective contraception (or abstain from heterosexual intercourse) from the time of signing consent until at least 120 days after the last dose, or 9 months after surgery.
• Men who agree to use contraception (or abstain from heterosexual intercourse) from the time of signing consent until at least 120 days after the last dose, or 9 months after surgery. Note: calendar-based methods and withdrawal are not considered acceptable contraception for this trial.
• People who are able to read, understand, and sign the informed consent form.

Who may not be able to join:

• People who have had another cancer diagnosis within the past 5 years, or who currently have another cancer — with some exceptions for certain early-stage or fully treated skin cancers, in situ cancers, Stage I lung cancer, and Stage I colorectal cancer (confirm with trial site).
• People who have had, or are planning to have, an organ or bone marrow transplant.
• People who have received a blood transfusion within 2 weeks before the first dose, or who have a history of significant bleeding, or who have experienced a severe bleeding event within 4 weeks before screening.
• People with abnormal blood clotting (INR above 1.5 without being on blood thinners), or who are taking blood-thinning medications — although low-dose warfarin (1 mg/day) or low-dose aspirin (up to 100 mg/day) for prevention may be acceptable if clotting levels are within range (confirm with trial site).
• People who have had a blood clot event within 6 months before screening, such as a stroke, mini-stroke (TIA), deep vein thrombosis (with some exceptions), or pulmonary embolism.
• People who have had a heart attack or uncontrolled abnormal heart rhythms (including certain electrical interval measurements on heart tracing) within 6 months before the first dose, or who have moderate-to-severe heart failure, or reduced heart pumping function on echocardiogram (below 50%).
• People whose urine tests show significant levels of protein in the urine (confirmed by a 24-hour urine protein level above 1.0 g).
• People who have difficulty swallowing, chronic diarrhoea, or bowel blockage that could affect how oral medications are absorbed.
• People who have clinically significant fluid build-up around the lungs or in the abdomen that requires medical intervention.
• People with HIV infection.
• People with active tuberculosis (TB).
• People with wounds or bone fractures that have not healed over a long period.
• People with certain serious lung conditions, such as interstitial lung disease, dust-related lung disease, radiation- or drug-related lung inflammation, or severely reduced lung function.
• People with known active or suspected autoimmune diseases, unless the condition is stable and not requiring immune-suppressing medication — with some exceptions for well-controlled mild conditions such as skin conditions, arthritis, or psoriasis (confirm with trial site).
• People with severe autoimmune diseases such as lupus, a history of ulcerative colitis, Crohn's disease, irritable bowel syndrome, sarcoidosis, or active hepatitis B or C. Note: people with hepatitis B with a low viral load (below 500 copies/ml) may be eligible (confirm with trial site).
• People who are taking systemic steroid medications at a dose above 10 mg/day prednisone equivalent, or other immune-suppressing drugs, within 14 days before the first dose — with exceptions for low-dose topical, inhaled, or replacement hormone therapy.
• People with an active infection requiring systemic treatment within 14 days before the first dose — though preventive antibiotic use may be acceptable (confirm with trial site).
• People who have received a live vaccine within 28 days before the first dose — inactivated seasonal flu vaccines are generally permitted (confirm with trial site).
• People who have previously been treated with checkpoint inhibitor drugs (such as PD-1, PD-L1, or CTLA-4 inhibitors).
• People who have received certain immune-modifying treatments (such as thymopentin, thymalfasin, interferons, or CAR-T therapy) within 6 months before the first dose.
• People currently taking part in another clinical trial, or who have completed another trial treatment within one month before starting this study.
• People with a known allergy or intolerance to any of the study drugs or their ingredients.
• People with a history of alcohol, drug, or substance misuse — though people who have stopped drinking may be eligible (confirm with trial site).
• People who are unable or unwilling to follow medical instructions or prescribed medications, or whose records are incomplete in ways that could affect the assessment of results.
• Women who are pregnant or breastfeeding.
• People with other serious health conditions that the trial investigators consider would make participation unsafe or unsuitable.
• People whom the trial investigator determines, for any other reason, are not suitable for the trial.

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