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 aged 18 or older.
• People who are generally well enough to carry out light activity and care for themselves (a doctor would assess this using a standard performance scale scored 0 or 1).
• People who have been confirmed by tissue testing to have one of the following cancer types: stomach cancer, cancer at the junction of the stomach and food pipe, cancer of the food pipe (all of the adenocarcinoma type), bowel/colorectal cancer, or primary liver cancer (hepatocellular carcinoma).
• People whose cancer is at an advanced stage (stage 4) or cannot be fully removed by surgery (stage 3).
• People whose cancer can be measured on scans according to standard criteria used in clinical trials.
• People who agree to have a tissue sample (biopsy) taken at the start of the trial, and possibly at other points during the trial.
• People with stomach, stomach-food pipe junction, or food pipe cancer who have already tried at least one standard treatment that either stopped working or could not be tolerated.
• People with colorectal (bowel) cancer who have already tried at least two standard treatments that either stopped working or could not be tolerated. For those whose cancer has a specific genetic profile (RAS wild type), prior treatment with certain targeted antibody therapies would also need to have been tried (confirm with trial site).
• People with liver cancer (HCC) in one specific group (cohort 3) who have tried at least one, but no more than two, previous treatments — or who could not tolerate them.
• People with liver cancer (HCC) in another specific group (cohort 4) who have either never received treatment, or who have tried at least one but no more than two previous treatments that stopped working or could not be tolerated.
• People whose tumour has been tested for certain genetic markers (MSI/MMR); if results are not yet available, testing may be arranged through a local laboratory.
• People who have recovered from side effects of previous cancer treatments, back to their normal baseline or to a mild level, before joining the trial.
• People weighing more than 66 lbs (30 kg).
• People with adequate liver, kidney, and bone marrow function as assessed by blood tests.
• Women who have gone through menopause, or women of childbearing potential who test negative for pregnancy before joining.
• Women of childbearing potential and men whose partners could become pregnant who agree to use highly effective contraception during the trial and for 180 days after finishing treatment. Men must also agree not to donate sperm during the trial and for 180 days after their last treatment.

Who may not be able to join:

• People who have previously been treated with certain immune checkpoint drugs (PD-1 or PD-L1 inhibitors, including durvalumab), unless they have liver cancer (HCC) or stomach/food pipe cancer, in which case prior use of these drugs may still be permitted (confirm with trial site).
• People who have previously been treated with cabozantinib or certain other targeted therapies that work on specific growth factor pathways (MET or HGF inhibitors), including crizotinib, foretinib, tivantinib, rilotumumab, or onartuzumab.
• People who have had certain serious stomach or bowel problems in the last 6 months, such as an abnormal opening (fistula), a hole in the bowel (perforation), a bowel blockage, or an abdominal abscess. This also includes people whose tumour is growing into the bowel wall in certain ways, or who have untreated or incompletely treated varicose veins in the stomach or food pipe that are bleeding or at high risk of bleeding.
• People with active conditions affecting the digestive system, such as stomach ulcers, Crohn's disease, diverticulitis, gallbladder inflammation, pancreatitis, or a blocked bile or pancreatic duct.
• People who are unable to swallow tablets.
• People with fluid build-up in the abdomen or around the lungs that cannot be controlled.
• People with certain types of lung lesions or cancer spread within the airways (confirm with trial site).
• People who have had significant bleeding — including coughing or vomiting more than half a teaspoon (2.5 ml) of blood — within the past 12 weeks, any sign of bleeding in the lungs within the past 3 months, or tumours that are growing into major blood vessels (though liver cancer patients with involvement of the liver's portal blood vessels may still be eligible — confirm with trial site).
• People who still have unresolved side effects rated as moderate or severe (Grade 2 or higher) from previous cancer treatments.
• People who have received radiotherapy covering more than 30% of their bone marrow, or a large area of radiotherapy, within the past 4 weeks.
• People who have had major surgery (such as bowel surgery or brain surgery) within the past 8 weeks.
• People who have taken immune-suppressing medications within the 14 days before starting the trial, with some exceptions such as steroid inhalers or low-dose systemic steroids (confirm with trial site).
• People who have previously received an organ transplant from another person.
• People with a current or past history of autoimmune or inflammatory conditions (confirm with trial site for specific exceptions).
• People with a history of a primary immune deficiency condition.
• People with active infections including tuberculosis, hepatitis B, hepatitis C, or HIV — though liver cancer patients with hepatitis B or C may be eligible under specific conditions (confirm with trial site).
• People who have received a live vaccine within 30 days before starting the trial.
• People with high blood pressure that remains uncontrolled despite taking blood pressure medication.
• People who have had a stroke, mini-stroke (TIA), heart attack, or a blood clot (such as in a leg vein or lung) within the past 6 months. People with a recent leg blood clot may still be eligible if it is stable, causing no symptoms, and has been treated with a specific type of blood thinner for at least 2 weeks (confirm with trial site).
• People with untreated cancer spread to the brain or the lining of the brain or spinal cord.
• People with serious medical conditions that would make trial participation unsafe (confirm with trial site).
• People with a history of another cancer, with some exceptions: a previous cancer that was fully treated with no signs of return and low risk of coming back; adequately treated certain skin cancers with no evidence of disease; or adequately treated early-stage cancer (carcinoma in situ) with no evidence of disease.
• People taking certain blood-thinning or anti-clotting medications, such as warfarin, or antiplatelet drugs such as clopidogrel. Some blood thinners are permitted, including low-dose aspirin for heart protection, low-dose preventive low-molecular-weight heparin (LMWH), and therapeutic-dose LMWH under specific conditions (confirm with trial site).
• People with a known allergy or sensitivity to any of the drugs used in this trial or their ingredients.

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