Phase 3 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 are at least 18 years old.
• People whose general physical functioning is rated as good (able to carry out normal daily activities, with at most mild symptoms limiting strenuous activity) — this is measured using a standard medical scale called ECOG, and a score of 0 or 1 is required (confirm with trial site).
• People who have been diagnosed with a specific type of stomach or gastroesophageal junction cancer (called microsatellite stable or mismatch repair proficient adenocarcinoma, Siewert type 3) that has either spread to the lining of the abdomen or has positive cancer cells found in abdominal fluid.
• People who have received at least 3 months but no more than 6 months of their first course of systemic cancer treatment.
• People who are registered to the trial within 4 weeks of their last dose of first-line treatment, and who have no ongoing serious side effects that would prevent them from having a keyhole camera procedure (diagnostic laparoscopy) or further treatment.
• People whose blood test results taken within 30 days before registration meet the following levels: white blood cell count at least 2,000 per microlitre, neutrophils (a type of white blood cell) at least 1,500 per microlitre, platelets at least 75,000 per microlitre, haemoglobin at least 8 g/dL, and albumin (a blood protein) at least 2.5 g/dL.
• People whose liver function tests are within acceptable ranges (taken within 30 days before registration), as assessed by the trial site.
• People whose kidneys are functioning well enough, with a kidney clearance rate of at least 30 mL/min (taken within 30 days before registration).
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People with a history of hepatitis B who have an undetectable viral load on appropriate treatment.
• 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 have had or currently have another cancer, as long as that cancer or its treatment is not expected to interfere with this trial's safety or results.
• People who are able to understand the trial and are willing to sign a consent form; people with impaired decision-making ability may still be considered eligible if they have a legally authorised representative or supportive family member available.
• People who have undergone a diagnostic laparoscopy (keyhole camera examination of the abdomen) with fluid samples taken for analysis, and who have had the extent of abdominal cancer spread measured using a standard scoring system called the Peritoneal Cancer Index (Step 1 randomisation requirement).

Who may not be able to join:

• People whose stomach or gastroesophageal cancer is of a type called microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
• People who have signs of cancer spread to other solid organs, except for the ovaries.
• People who have significant worsening of abdominal (peritoneal) cancer spread seen on imaging during their first-line treatment.
• People who have blockage of the small or large bowel (other than a blockage at the stomach outlet caused by the primary tumour).
• People with extensive cancer spread to lymph nodes at the back of the abdomen that could not be removed during stomach surgery.
• People with a history of abdominal surgery that would make a diagnostic laparoscopy or port placement unsafe.
• People with large amounts of fluid in the abdomen, or who have needed fluid drainage of more than 1 litre on two or more occasions in the 30 days before registration.
• People with heart conditions rated as class III or IV on the New York Heart Association scale (meaning significant limitations on physical activity or symptoms at rest).
• People with serious uncontrolled illness or other significant health conditions that would make participation unsafe.
• People with known allergies or medical reasons preventing use of the trial drugs: paclitaxel, 5-fluorouracil, or leucovorin.
• People who are pregnant or breastfeeding; a pregnancy test is required within 14 days before registration for anyone who could become pregnant.
• People who are not willing or able to use effective contraception for the duration of the trial and for at least 3 months after the last dose of treatment (requirements vary by treatment arm — confirm with trial site).
• People who have extensive internal abdominal scarring (adhesions) found during the laparoscopy that would make it unsafe to place the internal treatment port (Step 1 randomisation requirement).

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