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 Stage IV cancer of the esophagus, stomach, pancreas, bile ducts (inside or outside the liver), gallbladder, small intestine (duodenum), or the area where the bile duct meets the small intestine (ampulla), confirmed by a tissue sample.
• People whose primary (main) tumor can be surgically removed or treated with radiation or ablation (a procedure that destroys tumour tissue).
• People whose cancer has spread to only a limited number of spots (up to 2 areas of the body), and where all spread can be completely removed or treated with curative intent — including up to 5 spots in the lungs, up to 5 spots in the liver, a small number of lymph node sites, or a limited amount of disease in the abdominal lining.
• People whose primary tumour was previously removed and who later developed a limited number of metastases (spread), at least 6 months after completing curative treatment.
• People whose blood tests show healthy enough organ function, tested within 30 days before starting the study.
• People who have had two negative ctDNA blood tests (a type of test that looks for cancer DNA in the blood) taken at different times, with the second test done within 45 days before joining the study.
• People who have already received at least 4 months of effective systemic (whole-body) cancer treatment.
• People with a haemoglobin level of at least 8 g/dL (a measure of red blood cells).
• People with an ANC of at least 1,500/uL (a measure of infection-fighting white blood cells).
• People with a platelet count of at least 75,000/uL (platelets help blood clot).
• People with total bilirubin no higher than 1.5 times the normal upper limit (a liver function measure).
• People with liver enzyme levels (AST and ALT) no higher than 5 times the normal upper limit.
• People with kidneys that are filtering well enough (creatinine clearance of at least 50 mL/min).
• People who are at least 18 years old and no older than 80 years old at the time of signing consent.
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard scale used by doctors to measure physical fitness for treatment (confirm with trial site).
• Male participants who agree to use contraception (barrier methods or abstinence) during treatment and for at least 95 days after completing treatment, and who agree not to donate sperm during this time.
• Female participants of childbearing age who are not pregnant, not breastfeeding, and who agree to use contraception during treatment and for at least 95 days after completing treatment, and who agree to inform their treating doctor immediately if pregnancy occurs or is suspected.
• People who are willing and able to provide written consent to participate, including a legal representative if applicable.

Who may not be able to join:

• People who have a positive pregnancy test within 3 days before starting treatment.
• People whose blood oxygen levels are low (below 92% at rest) or who need supplemental oxygen.
• People whose cancer has continued to grow or spread while on their current cancer treatment.
• People who have another active or recently treated cancer (within the past 3 years), not including certain treated skin cancers or carcinoma in situ that have been successfully treated.
• People who have cancer that has spread to the brain or the lining around the brain or spinal cord.
• People who have cancer that has spread to the bones.
• People with serious heart conditions, including unstable chest pain, a heart attack within the past 6 months, or severe heart failure (confirm with trial site for specific heart rhythm conditions).
• People with poorly controlled high blood pressure (top number at or above 150 mmHg and/or bottom number at or above 90 mmHg).
• People with moderate to severe liver disease (classified as Child-Pugh B or C).
• People with a psychiatric illness or substance use problem that would make it difficult to follow the study requirements.
• People who are unable to swallow tablets or who have a digestive condition that would prevent proper absorption of oral medication.
• People with cancer-related fluid build-up in the lining of the lungs, or a history of such fluid that was previously treated.
• People whose cancer type does not match those listed as eligible — for example, squamous cell cancers of the oesophagus, neuroendocrine tumours, or liver cancer (hepatocellular carcinoma).
• People whose primary tumour cannot be treated using the methods the trial uses.
• People with an albumin (protein) level below 3.0 g/dL even after nutritional support.
• People who have detectable cancer DNA in their blood (ctDNA) at the time of joining.
• People who have an active infection currently being treated with antibiotics or other systemic medications.
• People with active tuberculosis (TB) or active COVID-19 infection.
• People with a known immune system condition, or those receiving immune-suppressing medications (including steroids above a certain dose) within 7 days before starting the trial.
• People who are pregnant, breastfeeding, or planning to conceive or father a child during the study period or within 95 days after the last treatment.
• People who are unable to receive chemotherapy, surgery, radiation, or ablative procedures for medical or insurance-related reasons.
• People who need emergency surgery due to bleeding, a perforation (a hole in an organ), or a blockage.

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