Phase 2 Stomach Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older, of any sex
• People who have been formally diagnosed (through tissue testing) with stomach cancer or cancer at the junction where the oesophagus meets the stomach (gastroesophageal junction adenocarcinoma)
• People whose cancer has gotten worse during previous treatment that included an immune checkpoint inhibitor (a type of cancer drug), or who were unable to tolerate that treatment
• People whose cancer tests negative for a protein called HER2
• People who are able to provide a tumour tissue sample collected before their first cancer treatment, for research testing — a fresh sample is preferred, but a stored sample may be acceptable
• People who have at least one tumour that can be measured on a scan, according to standard medical criteria
• People who are generally well enough to carry out light activity and care for themselves, based on a standard medical rating scale (ECOG score of 0 or 1)
• People with a life expectancy of at least 12 weeks
• People whose blood counts and organ function (including liver, kidneys, heart, and bone marrow) meet the minimum levels required by the trial, as confirmed through blood and heart tests
• People whose blood clotting levels fall within an acceptable range, or who are on a stable dose of blood-thinning medication (confirm with trial site)
• Women who could become pregnant must return a negative pregnancy test within 14 days before joining, and must agree to use reliable contraception during the trial and for 3 months after the last dose; men must be surgically sterile or agree to use reliable contraception over the same period
• People who have recovered from side effects of earlier treatments to a mild level or better, and whose surgical wounds (if any) have fully healed
• People who are willing to take part voluntarily, sign a consent form, and are expected to be able to follow the trial requirements

Who may not be able to join:

• People who have had a hole or abnormal opening in the gastrointestinal tract (gut) in the past 6 months, or active gut bleeding in the past 3 months
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that needs repeated draining
• People with a known allergy to any ingredient in the study drugs
• People who have taken another experimental drug within 4 weeks before the trial (or within 5 half-lives of that drug, whichever is longer)
• People who are currently enrolled in another interventional clinical trial
• People who have received any cancer treatment (including radiotherapy, chemotherapy, immunotherapy, targeted therapy, or similar) within 2 weeks before joining
• People who have needed high-dose steroid medication (more than the equivalent of 10 mg of prednisone daily) within 2 weeks before joining — some limited steroid use may be permitted (confirm with trial site)
• People who have received an anti-tumour or live vaccine within 4 weeks before joining
• People who have had major surgery or a serious injury within 4 weeks before joining
• People with cancer that has spread to the lining of the brain or spinal cord, or with active brain metastases — people with stable, treated brain metastases may be discussed on a case-by-case basis (confirm with trial site)
• People with an active autoimmune disease, or a history of one requiring systemic treatment in the past 2 years — some exceptions may apply (confirm with trial site)
• People with a weakened immune system, including those who are HIV positive, have had an organ or bone marrow transplant, or have active hepatitis
• People with poorly controlled heart conditions, including moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or uncontrolled irregular heartbeat
• People who have had a serious infection within 4 weeks before joining, or signs of an active infection or lung inflammation within 2 weeks before joining
• People with a history of scarring or inflammation of the lung tissue (interstitial lung disease)
• People with active tuberculosis (TB), a history of active TB in the past year, or prior TB that was not properly treated
• People who have been diagnosed with another cancer within the past 5 years — some exceptions for low-risk cancers may apply (confirm with trial site)
• People who are pregnant or breastfeeding
• People whom the trial doctors consider unsuitable for safety or other reasons

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