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 are willing and able to sign a written consent form before any study-related procedures begin.
• People aged between 18 and 75 years.
• People who have had surgery to remove their stomach cancer, including removal of nearby lymph nodes (D2 or more extensive dissection), with no cancer left behind after the operation (R0 resection).
• People who did not receive any systemic anti-cancer treatment (such as chemotherapy or immunotherapy) before their surgery.
• People whose cancer has been confirmed by laboratory testing to be a type called gastric adenocarcinoma (a specific type of stomach cancer).
• People whose cancer has been staged as TxN3M0 according to a specific medical staging system (the 8th edition AJCC system), meaning the cancer had spread to many nearby lymph nodes but not to distant parts of the body (confirm with trial site).
• People whose tumour tests positive for a protein called PD-L1, with a Combined Positive Score (CPS) of 1 or higher.
• People who are in reasonably good general health, rated 0 or 1 on a standard activity scale used in cancer research (ECOG PS), meaning they are fully active or have only minor restrictions on physical activity.
• People whose doctors expect them to survive for at least 6 months.
• People whose blood test results show that their bone marrow, liver, kidneys, and other organs are functioning adequately — including healthy levels of blood cells, liver enzymes, kidney function, clotting, thyroid hormones, and heart muscle markers — all measured without recent blood transfusions, growth factor injections, or related medical support (confirm specific values with trial site).
• Women who could potentially become pregnant must have a negative pregnancy test within 3 days before starting the study drug.
• All participants who could potentially conceive a child must use highly effective contraception throughout the treatment period and for at least 120 days after the last dose of the study drug, or 180 days after the last dose of chemotherapy.

Who may not be able to join:

• People whose stomach cancer is confirmed to be a different type, such as squamous cell carcinoma, adenosquamous carcinoma, undifferentiated carcinoma, neuroendocrine tumour, or gastrointestinal stromal tumour (though mixed tumours where adenocarcinoma makes up more than 80% of the cancer may still be eligible — confirm with trial site).
• People who have been diagnosed with another cancer within the past 5 years, with some exceptions for certain skin cancers, thyroid cancer, or pre-cancerous conditions that were fully treated.
• People who are currently taking part in another therapeutic clinical trial, or who have received another experimental drug within the 4 weeks before starting this study.
• People who have previously received certain types of immunotherapy drugs, including anti-PD-1, anti-PD-L1, or other drugs that work on immune system checkpoint proteins (such as those targeting CTLA-4, OX-40, or CD137).
• People who have received certain traditional Chinese medicines with anti-tumour effects, or immune-modulating drugs such as thymosin, interferon, or interleukin (by systemic treatment) within the 2 weeks before starting the study drug.
• People who have had an active autoimmune disease requiring systemic treatment within the past 2 years (note: hormone replacement therapies such as thyroid medication, insulin, or low-dose steroids for certain gland conditions are not considered systemic treatment in this context).
• People who have received systemic steroid therapy or other immunosuppressive therapy within the 7 days before starting the study drug, except for low physiological doses of steroids (equivalent to 10 mg or less of prednisone per day) or topical/inhaled forms.
• People who have had an organ transplant (other than a corneal transplant) or a stem cell transplant from a donor.
• People with a known allergy to any of the drugs used in this study.
• People who have not yet fully recovered from side effects or complications of previous treatments before the study begins (confirm with trial site).
• People with a known history of HIV infection.
• People with untreated, active hepatitis B infection above certain viral levels, though people with hepatitis B who meet specific criteria around viral load and ongoing antiviral treatment may still be eligible (confirm with trial site).
• People with active hepatitis C infection confirmed by both a positive antibody test and detectable virus levels.
• People who have received a live vaccine within the 30 days before starting the study drug (injected inactivated flu vaccines are generally permitted, but nasal live flu vaccines are not).
• Women who are pregnant or currently breastfeeding.
• People with serious or poorly controlled health conditions, including certain heart rhythm problems, heart failure, recent heart attack or stroke (within 6 months), poorly controlled high blood pressure despite medication, a recent history of a type of lung inflammation that required steroid treatment, active tuberculosis, active or uncontrolled infections, certain bowel or liver problems, poorly controlled diabetes, significant protein in the urine, or mental health conditions that would prevent participation in the study.
• People with any other medical history, test results, or circumstances that the trial investigators consider unsuitable for safe participation in the study.

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