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, of any gender
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and food pipe, confirmed through a biopsy taken during a camera examination of the stomach
• People whose cancer has been confirmed by imaging scans (such as CT, MRI, or ultrasound) to be at a specific stage — not yet spread to distant parts of the body, but meeting certain local spread criteria (confirm with trial site for exact staging details)
• People who are able to provide at least 15 tissue samples from their tumour (either stored samples or fresh tissue) for laboratory testing
• People who are generally well enough to carry out light activity and care for themselves, as measured by a standard health performance scale (ECOG score of 0 or 1)
• People whose blood counts and organ function (including bone marrow, liver, and kidneys) meet the specific healthy ranges required by the trial (confirm with trial site for exact values)

Who may not be able to join:

• People who have had a severe allergic reaction to another monoclonal antibody medicine, or to any ingredient in the study drug (toripalimab/JS001)
• People whose biopsy showed a different cancer type, such as squamous cell carcinoma or a neuroendocrine tumour
• People who have had, or currently have, another cancer within the past 5 years
• People who have previously been treated with certain immune checkpoint medicines (anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies)
• People with a history of autoimmune disease — though people with autoimmune-related thyroid conditions on a stable hormone replacement dose, or people with Type 1 diabetes well-controlled on a stable insulin plan, may still be considered eligible (confirm with trial site)
• People who have received immune-stimulating medicines (such as interferon or IL-2) within 4 weeks before enrolling, or within 5 half-lives of that medicine, whichever is the shorter period
• People who have previously had a bone marrow transplant from a donor, or a solid organ transplant
• People with active infections, including active tuberculosis, active hepatitis B (with specific virus levels above a set threshold), active hepatitis C, or HIV
• People with a previous hepatitis B infection that has cleared may still be considered, but only if a specific virus level test comes back negative (confirm with trial site)
• People who test positive for hepatitis C antibodies may still be considered, but only if a further virus test (PCR) comes back negative (confirm with trial site)
• People with serious neurological or mental health conditions, including dementia or seizures
• People with moderate or severe nerve damage in the hands or feet (peripheral neuropathy graded 2 or above on a standard scale)
• People who are pregnant or currently breastfeeding
• People with long-term bowel disease or short bowel syndrome
• People with a deficiency of an enzyme called dihydropyrimidine dehydrogenase (DPD)
• People with significant heart conditions, such as a heart attack within the past 3 months, unstable irregular heartbeat, unstable chest pain, or heart failure rated at a certain level of severity
• People with known coronary artery disease or reduced heart pumping function (ejection fraction below 50%) who are not on a stable, optimised treatment plan as determined by their treating doctor

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