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 have been diagnosed with a specific type of cancer (adenocarcinoma) of the esophagus, the junction between the esophagus and stomach, or the stomach — but not squamous cell tumors, and not tumors that test positive for a protein called HER2.
• People whose cancer can be seen and tracked on imaging scans (such as CT scans), whether or not individual tumors are large enough to be formally measured.
• People who have not received any treatment for Stage IV (advanced/spread) disease. People who had earlier preventive (adjuvant) treatment are eligible if that treatment ended more than 6 months before joining the trial.
• People aged 18 or older (children are excluded because there is no safety data for the study drug in people under 18).
• People with a general health and activity level rated at 0, 1, or 2 on a standard scale used by doctors to assess how well a person can carry out daily activities (ECOG Performance Status 0–2).
• People whose blood test results show the bone marrow, liver, and kidneys are functioning within acceptable ranges — including adequate white blood cell counts, red blood cell levels, platelet counts, liver enzyme levels, kidney function, urine protein levels, and blood clotting levels (confirm specific numbers with trial site).
• People with a chronic hepatitis B infection, provided the virus is undetectable in the blood while on suppressive treatment (if treatment is needed).
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently on treatment with an undetectable viral load.
• People who previously had treated brain metastases (cancer that spread to the brain) may be considered if they have been off steroid medications for more than 2 weeks and imaging has shown the brain metastases have been stable for at least 4 weeks — this would be decided in discussion with the trial's principal investigator.
• People who have or have had another type of cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
• Women who could become pregnant and men must agree to use effective contraception during the study and for 9 months after the last dose of any study treatment. Any pregnancy that occurs during the study must be reported to the treating doctor immediately.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People who have previously been treated with a type of immunotherapy called a PD-1 or PD-L1 inhibitor, unless that treatment was completed more than 6 months before joining the trial as part of earlier preventive (adjuvant) therapy.
• People who have had major surgery or serious physical trauma within 4 weeks before joining, or who are planning major surgery within 4 weeks after the first dose. People who have had minor procedures within 3 days before joining are also excluded (with some exceptions — confirm with trial site).
• People who have not yet recovered from side effects of earlier cancer treatment, except for hair loss or mild (grade 1 or lower) nerve-related symptoms such as tingling or numbness.
• People who are currently taking part in another clinical trial using an investigational treatment for this condition.
• People with a known history of serious allergic reactions to drugs chemically similar to the study drug (ivonescimab). People who previously had allergic reactions to certain chemotherapy drugs used in this trial may still be eligible if they have undergone a medically supervised desensitisation process and have been shown to tolerate the drugs at standard doses (confirm with trial site).
• Women who are pregnant or breastfeeding.
• People with a history of a hole (perforation) or abnormal channel (fistula) in the digestive tract, a history of bowel blockage requiring intravenous nutrition, or major bowel removal surgery within 6 months before joining.
• People with significantly high blood pressure (top number 150 or higher, or bottom number 100 or higher) even after taking blood pressure medication by mouth.
• People who have had a serious blood clot in an artery (any grade), a severe blood clot in a vein (grade 3 or above), a mini-stroke (TIA), a stroke, a hypertensive crisis, or a condition involving dangerous swelling in the brain from high blood pressure — within the 12 months before joining.
• People with a documented history of poor wound healing.
• People who have previously received an organ transplant or a stem cell transplant from another person.
• People with ongoing serious illness or health conditions that, in the treating doctor's opinion, would make it unsafe or impractical to participate.
• People with mental health conditions or personal circumstances that would make it difficult to follow the study requirements.
• People who have had unstable chest pain (angina), a heart attack, significant heart failure, serious blood vessel disease, or other significant heart problems requiring hospitalisation within 12 months before joining, or who have poorly controlled heart rhythm problems or reduced blood supply to the heart.
• People who need to take steroid medications (above a low daily dose equivalent) or other immune-suppressing medications, within 14 days before starting treatment. Pre-medications to prevent allergic reactions to imaging dye are allowed.
• People with an active serious infection requiring intravenous antibiotics or intravenous antibody treatments within 7 days of starting the study.
• People with HIV are generally excluded, but may be eligible if they meet all of the following: they have been on stable HIV treatment for at least 12 weeks, have no history of AIDS-defining illnesses, have an adequate immune cell count and an undetectable HIV viral load at screening, have no significant HIV-related complications, and are not taking medications that could interfere with the study drugs (confirm with trial site).
• People with a history of bleeding problems or significant bleeding episodes within 4 weeks before joining — including coughing up blood (half a teaspoon or more), nosebleeds involving fresh blood, or unstable use of blood-thinning medications. Stable use of blood thinners may be permitted if blood clotting levels are within acceptable ranges (confirm with trial site).
• People who have had lung inflammation (not caused by infection) that required treatment within 4 weeks before joining.

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