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:

• People who have given written consent to take part before any trial procedures begin (if someone is physically unable to sign, a trusted person of their choice may confirm consent in writing on their behalf)
• People whose stomach cancer or cancer of the junction between the oesophagus and stomach has been confirmed through a tissue or cell sample
• People whose cancer has spread or cannot be removed by surgery (stage IV)
• People who have at least one area of cancer that can be measured on a scan, according to standard criteria
• People with a good general level of daily functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work)
• People aged 18 or older
• People whose cancer does not have certain targetable markers (HER2 and Claudin 18.2 negative, regardless of PD-L1 status) and who have not yet received any treatment for advanced disease (Cohort 1), OR people whose cancer has at least one targetable marker (PD-L1 CPS of 1 or above, and/or HER2 positive, and/or Claudin 18.2 positive) and who have received exactly one prior treatment for advanced disease (Cohort 2)
• People whose blood counts are within acceptable ranges, including white blood cells, platelets, and haemoglobin levels (confirm with trial site for exact values)
• People whose kidneys are working well enough, based on standard blood and urine tests (confirm with trial site for exact values)
• People whose liver is working well enough, based on standard blood tests (confirm with trial site for exact values)
• People whose blood clotting is within acceptable ranges, or who are on a stable dose of blood-thinning medication
• People who are able and willing to use effective contraception throughout the trial and for at least 120 days after the last dose of the study drug (ivonescimab), and who agree not to donate sperm or eggs during this period — this applies to people who could become pregnant and to unsterilised males whose partner could become pregnant
• People who are able to become pregnant must have a negative pregnancy blood test within 3 days before joining and a negative urine pregnancy test on the day of the first dose
• People who are willing and able to follow all trial requirements, including visits, tests, and procedures
• People who are covered by the Social Security System or an equivalent scheme

Who may not be able to join:

• People who have had or currently have a different type of cancer (at a different site or of a different cell type) within the past 2 years, with some exceptions such as certain early-stage skin cancers, early bladder tumours, or cervical cancer in situ that was fully treated
• People whose tumour has a specific genetic feature known as high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)
• People taking in fewer than 1,500 calories per day through eating, or who have lost more than 15% of their body weight in the past 6 months
• People who still have significant side effects from previous cancer treatment that have not improved to a mild level (grade 1 or lower), except for hair loss
• People who have had major surgery or serious injury within 4 weeks before starting treatment, or who have major surgery planned within 4 weeks after the first dose; also people who have had minor procedures in the 3 days before treatment (with some exceptions such as certain catheter placements — confirm with trial site)
• People who have a history of serious bleeding problems or who have had significant bleeding episodes in the 4 weeks before joining, including coughing up blood, significant nosebleeds, or unstable use of blood-thinning or anti-clotting medications
• People with poorly controlled high blood pressure (repeatedly high readings even with medication)
• People who have had serious heart problems requiring hospitalisation in the past 12 months, such as unstable angina, heart attack, significant heart failure, or dangerous irregular heart rhythms
• People who have had stomach or oesophageal vein bleeds, severe ulcers, abdominal abscesses, or acute gastrointestinal bleeding in the past 6 months
• People who have had a serious blood clot in an artery, a severe blood clot in a vein, a stroke, a mini-stroke, or a severe hypertensive crisis in the past 12 months
• People who have had a sudden worsening of chronic lung disease (COPD) in the 4 weeks before joining
• People who have had a hole or abnormal connection in the digestive tract, a bowel blockage, or major bowel surgery in the past 6 months
• People whose scans show that the cancer is growing into or around major blood vessels, that there are hollow areas forming inside the tumour, or that there is a higher risk of bleeding near any implanted device
• People who have been taking immune-suppressing medications (such as corticosteroids above a certain dose) for more than 7 days within the 2 weeks before treatment starts, with some exceptions for hormone replacement therapy for certain gland conditions
• People who have an active autoimmune disease (where the immune system attacks the body) that has required systemic treatment in the past 2 years — some exceptions apply for certain well-controlled conditions such as thyroid disease on replacement therapy, controlled Type 1 diabetes on insulin, or mild, stable skin conditions (confirm with trial site)
• People who have had a bone marrow transplant from a donor or a solid organ transplant
• People with a known history of, or signs of, scarring or inflammation in the lungs (interstitial lung disease)
• People with HIV that is not well controlled (people with an undetectable viral load and adequate immune cell counts on stable treatment may still be considered — confirm with trial site)
• People with active chronic hepatitis B or C infection
• People who are known to have a complete inability to process a chemotherapy drug called fluorouracil, if that drug is part of their planned treatment
• People whose overall condition, in the opinion of the treating doctor, makes trial participation unsuitable or unsafe
• People who are pregnant or breastfeeding
• People who have taken part in another treatment trial within 30 days before joining (participation in an observational study without treatment would generally be acceptable)
• People who are unable or unwilling to attend required follow-up visits for personal, geographic, family, or psychological reasons
• People who are detained, under court protection, or under legal guardianship

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