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 able to give written, signed, and dated consent to take part
• People who have a good general performance level (able to carry out normal daily activities with little or no limitation, rated 0 or 1 on a standard medical scale)
• People aged 18 to 75 years old; people over 75 may still be considered if they score above 14 on a standard health assessment questionnaire and are fit for surgery and repeat stomach camera procedures
• People who have been diagnosed by tissue sample (biopsy) with stomach or oesophageal-stomach junction cancer that has not spread to other parts of the body, at a specific stage confirmed by CT scan and internal ultrasound
• People whose cancer does not involve spread to the lining of the abdomen (peritoneal carcinomatosis), confirmed by scans and sometimes a keyhole examination
• People who have not previously received chemotherapy, radiotherapy, or immunotherapy for this stomach or oesophageal-stomach junction cancer
• People whose tumour has been confirmed to have a specific genetic marker called dMMR/MSI-H, verified by two laboratory tests and approved by the trial sponsor
• People whose blood counts meet minimum required levels (sufficient white blood cells, platelets, and haemoglobin)
• People whose kidneys are functioning at an adequate level based on blood tests
• People whose liver is functioning at an adequate level based on blood tests
• People whose blood clotting levels are within acceptable ranges (or within a safe therapeutic range if already on blood-thinning medication)
• People who have had a CT scan of the chest, abdomen, and pelvis within 28 days before joining, showing no spread of disease
• Women who are not pregnant or breastfeeding, and who either cannot become pregnant or have had a negative pregnancy blood test within 72 hours before the first dose, and agree to use highly effective contraception during and for 4 months after treatment
• Men who agree not to donate sperm and to use a condom during and for 4 months after treatment
• People who can provide tumour tissue samples and endoscopy images from their stomach camera procedure
• People who are willing and able to attend all scheduled visits, tests, and study procedures
• People enrolled in a national health care system (as required in France)

Who may not be able to join:

• People who have already received any anti-cancer treatment (chemotherapy, targeted therapy, or immunotherapy) for this cancer
• People who have taken part in another clinical trial with an experimental medicine within 28 days before joining
• People on blood-thinning medication or with a clotting disorder that makes taking biopsies during a stomach camera procedure unsafe
• People who have had major surgery within 28 days before the first dose of study treatment
• People with serious, uncontrolled medical conditions or active infections requiring ongoing treatment (for example, active lung inflammation, uncontrolled heart rhythm problems, a heart attack within the past 90 days, uncontrolled seizures, or serious psychiatric or substance use conditions)
• People with another current or previous cancer, unless it was a fully treated cervical cancer in situ, a skin cancer (basal or squamous cell), or a cancer that has been in complete remission for 3 or more years
• People whose cancer has already spread (metastatic disease)
• People who are pregnant or breastfeeding
• People with HIV
• People with active hepatitis B or C infection (people with past resolved hepatitis B, or hepatitis C antibodies but negative for active virus, may still be considered — confirm with trial site)
• People who are under legal guardianship or are unable to give informed consent
• People who are unable to comply with study follow-up requirements for geographic, social, or psychiatric reasons
• People whose tumour is located at the pylorus (the lower outlet of the stomach)
• People with a history of autoimmune disease (such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, and others); people with stable autoimmune thyroid disease on thyroid hormone replacement or well-controlled Type 1 diabetes may still be considered (confirm with trial site)
• People with a history of certain lung conditions, including idiopathic pulmonary fibrosis, drug-induced lung inflammation, or organising pneumonia, or who have signs of active lung inflammation on a screening chest scan
• People who have received a live vaccine within 14 days before the first dose of study treatment, or who are expected to need one during the study
• People who have previously received immunotherapy drugs that target checkpoint pathways (such as PD-1, PD-L1, CTLA-4, or CD137)
• People who have previously had a bone marrow transplant from a donor or a solid organ transplant
• People who have used steroid tablets or other immune-suppressing medicines within 2 weeks before starting treatment, or who will need them during the study (certain low-dose, inhaled, topical, or short-course exceptions may apply — confirm with trial site)

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