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 79 years old, either male or female.
• People who have been diagnosed through laboratory testing with stomach cancer (gastric adenocarcinoma) or cancer at the junction of the stomach and food pipe (gastroesophageal junction adenocarcinoma, specifically Siewert type II or III), with known PD-L1 expression results.
• People whose cancer has been tested and shown to have a stable genetic profile (known as pMMR or MSS status).
• People whose main stomach tumour can be surgically removed, and who have only limited spread to other areas — such as nearby lymph nodes, a small number of liver or lung spots (up to 5), ovaries, adrenal glands, certain bone areas, or other limited sites as assessed by the research team (confirm with trial site for full details on what counts as "limited spread").
• People who have not previously received any anti-cancer treatment.
• People who are well enough to undergo major abdominal surgery, with an ECOG performance score of 2 or below (a measure of how much daily activities are affected by illness).
• People with a life expectancy of at least 3 months.
• People whose organ function and overall physical condition are suitable for major abdominal surgery.
• People who are willing and able to follow the study requirements throughout the trial.
• Women who could become pregnant must have a negative pregnancy test before joining and must agree to use effective contraception during the study and for 180 days after the last dose; men who have not been surgically sterilised must also agree to use effective contraception.
• People who have read and signed an informed consent form, understanding that withdrawal from the study is possible at any time.

Who may not be able to join:

• People who are unable to swallow or absorb oral (tablet/capsule) chemotherapy.
• People whose stomach cancer is limited to the innermost layers of the stomach wall and has spread only to the ovaries.
• People who have cancer that has spread to the brain or the lining around the brain and spinal cord.
• People with a known allergy to any ingredient in the study medications.
• People who have had another cancer in the past, or currently have another cancer — except for certain fully treated skin cancers, superficial bladder cancer, early-stage cervical or breast changes, or any other cancer with no recurrence for at least 5 years.
• People with fluid build-up around the lungs, heart, or in the abdomen that is not able to be controlled.
• People who have lost 20% or more of their body weight in the two months before joining the trial.
• People with a blockage or significant dysfunction in the upper digestive tract.
• People who have previously received chemotherapy, radiotherapy, immunotherapy, or surgery intended to cure their cancer.
• People who have previously received treatments that target the PD-1, PD-L1, or PD-L2 pathways, or other therapies that act on T-cells.
• People who have used systemic steroids or immune-suppressing medications within 14 days before joining.
• People who have received a live vaccine within 4 weeks before joining.
• People with a serious systemic illness that is not well controlled.
• People with active autoimmune diseases, or a history of autoimmune disease that may return.
• People with severe or active infections currently requiring antibiotic, antifungal, or antiviral treatment.
• People with a significant history of lung disease.
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People who test positive for hepatitis B surface antigen (HBsAg) with a viral load of 500 IU/mL or higher.
• People who test positive for HIV.
• People with any other condition that, in the research team's assessment, may affect their ability to safely participate in or complete the study.

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