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 aged 18 or older who are willing and able to follow the study schedule, including visits, treatments, and tests.
• People who have been diagnosed with a specific type of stomach or gastroesophageal junction cancer (adenocarcinoma) confirmed by laboratory testing of tissue samples.
• People whose cancer is locally advanced and cannot be surgically removed, or has spread to other parts of the body, and who have not previously received systemic (whole-body) treatment for this cancer.
• People who previously received chemotherapy before or after surgery aimed at curing the cancer, provided their cancer did not spread or return within 6 months of finishing that treatment.
• People who can provide a tumour tissue sample (either archived from within the last 3 years, or newly collected) that tests positive for a protein called CLDN18.2, meaning at least 25% of tumour cells show a certain level of this protein on their surface (confirm with trial site).
• People whose tumour tissue has tested negative for a protein called HER2, confirmed by specific laboratory methods.
• People who have at least one tumour that can be measured using standard imaging criteria.
• People whose doctors expect them to survive for at least 3 months.
• People who are in reasonably good general physical condition, rated 0 or 1 on a standard scale used by doctors to assess daily functioning (confirm with trial site).
• People whose blood test results show their bone marrow, blood clotting, liver, kidneys, and heart are all functioning at adequate levels as defined by the trial (confirm with trial site for specific values).
• Women of childbearing potential who have a negative blood pregnancy test within 7 days before starting treatment, and who agree to use highly effective contraception throughout the study and for 7 months after the last dose.
• Men who are fertile and agree to use highly effective contraception throughout the study and for 7 months after the last dose, and who agree not to donate sperm during this time.
• Women who agree not to breastfeed during the study period.

Who may not be able to join:

• People whose cancer has been confirmed to be a different type, such as squamous cell carcinoma, sarcoma, or undifferentiated carcinoma.
• People whose stomach cancer tumours, as seen on imaging, have cavities or tissue death and are close to major blood vessels in a way that the treating doctor considers to carry a high risk of serious bleeding.
• People with cancer that has spread to the central nervous system (brain or spinal cord), except in certain cases where brain metastases have been treated, are stable, and meet specific criteria as assessed by the treating doctor (confirm with trial site).
• People with uncontrolled fluid build-up in body cavities (such as the abdomen), or a history of bowel obstruction, or who have undergone or are planning drainage procedures within 14 days before screening.
• People with spinal cord compression causing symptoms, or where symptoms are expected to develop without treatment, unless previously treated and stable for at least 4 weeks before the first study dose — or unless imaging shows asymptomatic compression assessed as stable and not currently requiring treatment.
• People with severe spread of cancer to the lining of the abdomen (peritoneum), particularly if this is causing significant bowel blockage or narrowing of the small intestine on imaging.
• People who have had a hole (perforation) or abnormal connection (fistula) in their digestive tract within the past 6 months, unless this has been surgically treated and the treating doctor considers it resolved or controlled.
• People whose cancer-related pain is not adequately controlled before the start of the study.
• People who weigh less than 35 kg, or who have lost more than 10% of their body weight in the 2 months before signing the consent form.
• People who have had another type of cancer within the past 2 years, with some exceptions such as certain fully treated skin cancers or carcinoma-in-situ.
• People with a history of autoimmune diseases (such as lupus, rheumatoid arthritis, or multiple sclerosis), with some exceptions for certain well-controlled or mild autoimmune conditions as assessed by the treating doctor (confirm with trial site).
• People who have previously had a bone marrow or solid organ transplant from another person.
• People with a history of serious heart or blood vessel problems, including certain abnormal heart rhythms, serious heart failure, recent heart attack, stroke, or aortic dissection within the past 6 months, or a history of heart muscle inflammation.
• People with HIV infection, or active hepatitis B or hepatitis C infection, unless specific conditions about viral levels and clinical status are met as assessed by the treating doctor (confirm with trial site).
• People with a known active syphilis infection.
• People with serious ongoing illnesses that are not under control, including active infections requiring antibiotic treatment within 2 weeks before the first dose, or lung inflammation requiring treatment during screening.
• People with known active tuberculosis.
• People currently experiencing nerve damage in their hands or feet (peripheral neuropathy) rated at grade 2 or above on a standard medical scale.
• People who have taken high-dose steroid medications or other immune-suppressing drugs within 2 weeks before the first study dose, with some exceptions for certain topical, inhaled, or low-dose uses (confirm with trial site).
• People who have difficulty swallowing, persistent uncontrolled vomiting, bowel obstruction, or chronic diarrhoea that would interfere with taking oral medications.
• People who have had uncontrolled or severe gastrointestinal bleeding, active stomach ulcers, or active gastrointestinal inflammation or infection within 28 days before joining the study.
• People whose side effects from previous cancer treatments have not recovered to a mild level (grade 1 or below) within 14 days before joining the study, with some exceptions as determined by the treating doctor.
• People with a known allergy to the study drugs (LM-302 or Ticagrelor) or their ingredients.
• People with known mental health conditions that may affect their ability to follow the trial requirements.
• People who are currently in another clinical trial using an experimental drug or device, or who have used an experimental drug within the past 28 days.
• People who have previously received treatments that specifically target the CLDN18.2 protein, or who have previously received a specific type of chemotherapy drug called MMAE delivered via an antibody-drug conjugate.
• People who have received local treatments such as radiotherapy or surgery to non-target areas within 2 weeks before the first dose, or who have not recovered from radiotherapy side effects within 2 weeks before joining.
• People who have received certain traditional Chinese medicines or immune-regulating medicines within 2 weeks before joining the study.
• People who have had or are planning to have major surgery or an interventional procedure (not including tumour biopsy) within 28 days before or during the study.
• People who have taken strong medications that affect how the body processes certain drugs (strong CYP3A4 inhibitors or inducers) within 14 days before joining the study (confirm with trial site).
• People who have received a live or weakened live vaccine within 28 days before joining the study.
• People whom the treating doctor considers unsuitable for this study for any other reason.

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