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:

• Adults between 18 and 75 years of age
• People who are able to understand the study details and are willing to sign a consent form
• People who have been confirmed by tissue or cell testing to have HER2-negative or unknown HER2 status stomach, esophageal, or stomach-esophageal junction cancer that has come back or spread (late-stage)
• People whose cancer has spread in a limited way — specifically, only to the liver (5 or fewer spots, each no larger than 5 cm) and/or certain nearby lymph nodes behind the abdomen, with no other distant spread, and where a surgeon considers the main tumour removable or potentially removable
• People who have at least one tumour that can be measured on scans, according to standard criteria (RECIST 1.1)
• People who have not previously been treated with certain targeted or immunotherapy drugs (VEGFR-targeted drugs or PD-1/PD-L1 antibodies); people who had chemotherapy after surgery are eligible if the cancer came back more than 6 months after finishing that chemotherapy and they had no significant lasting side effects from it
• People with a good general performance level (able to carry out daily activities with little or no restriction, scored 0–1 on a standard scale)
• People whose expected survival is at least 3 months
• People whose blood counts, liver function, kidney function, heart function, thyroid function, and body weight meet specific health thresholds confirmed by tests done within 14 days before joining (confirm with trial site for exact values)

Who may not be able to join:

• People who currently have, or have previously had, another cancer — although some early-stage or cured cancers (such as certain skin cancers, early cervical, lung, or bowel cancers) may be considered on a case-by-case basis by the trial doctor
• People who have taken part in another clinical drug trial within the past 4 weeks
• People who have difficulty taking oral (swallowed) medication, for example due to trouble swallowing, ongoing severe diarrhoea, or bowel blockage
• People who have a history of significant bleeding, or who have had a serious bleeding event (grade 3 or higher) in the 4 weeks before screening
• People whose cancer has spread to other distant sites such as the lungs, brain, bones, distant lymph nodes, or the lining of the abdomen
• People with high blood pressure not well controlled by one medication, a history of unstable chest pain, a heart attack in the last 6 months, new chest pain in the last 3 months, certain heart rhythm problems, or moderate-to-severe heart failure
• People with wounds that have not healed over a long period, or fractures that have not fully healed
• People whose cancer appears on scans to be growing into or very close to major blood vessels, where the trial doctor judges there is a high risk of serious bleeding
• People with abnormal blood clotting or a tendency to bleed; people currently taking blood-thinning medications such as warfarin (except very low-dose preventive use) or heparin (confirm with trial site)
• People who have had a stroke, mini-stroke, deep vein blood clot, or pulmonary embolism (blood clot in the lungs) within the 6 months before screening
• People whose urine tests show a high level of protein confirmed by a 24-hour urine collection test
• People who have previously received immune-targeted therapy drugs
• People with a history of immune system deficiency, other immune conditions, or who have had an organ transplant
• People with active lung inflammation or infection requiring steroid treatment
• People with a history of certain serious autoimmune conditions (such as lupus), inflammatory bowel diseases (such as Crohn's disease or ulcerative colitis), chronic diarrhoea conditions, sarcoidosis, tuberculosis, active hepatitis B or C, or HIV — though some well-controlled milder autoimmune conditions or low-level hepatitis B may be considered (confirm with trial site)
• People with a known allergy to monoclonal antibody treatments
• People with a history of substance abuse involving psychotropic drugs that cannot be stopped, or people with a diagnosed mental disorder
• People who are unlikely to follow medical instructions or complete the study as required
• People with other serious conditions that, in the trial doctor's judgement, would put them at risk or prevent them from completing the study

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