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 are willing to take part voluntarily, are able to sign a consent form, and are likely to follow the study requirements
• People aged 18 to 75 years old at the time of signing the consent form, of any gender
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by lab testing of tissue or cell samples, where the cancer is locally advanced (but has not spread to distant parts of the body), and where the treating doctor considers surgery to remove the cancer to be possible
• People who have not previously received any treatment for this cancer, including radiation therapy, chemotherapy, or immunotherapy
• People whose tumour tissue test (IHC) shows a certain level of HER2 protein expression (IHC 1+, 2+, or 3+)
• People with a good general performance status, meaning they are fully active or have only minor restrictions on physical activity (ECOG score 0–1)
• People whose life expectancy is estimated to be at least 6 months
• People whose major organs (such as heart, liver, and kidneys) are functioning adequately
• People who are capable of having children must use appropriate contraception throughout the study and for 120 days after it ends, must have a negative pregnancy blood test within 7 days before joining, and must not be breastfeeding

Who may not be able to join:

• People who have been diagnosed with another type of cancer in the past 5 years, with the exception of certain skin cancers or pre-cancerous conditions that were fully treated and removed
• People whose tumour shows signs of bleeding risk — for example, active ulcers, a positive stool blood test, a history of vomiting blood or black stools within the past 2 months, or a doctor-assessed risk of gastrointestinal bleeding — or people who received a blood transfusion within 4 weeks before starting the study
• People who are unable to swallow oral medication
• People who are currently taking part in another clinical trial involving a treatment intervention, or who received another experimental drug or used an experimental device within 4 weeks before the study start
• People who have previously been treated with anti-HER2 therapies, anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or other drugs that act on certain immune system pathways (such as those targeting CTLA-4, OX-40, or CD137)
• People who received certain traditional Chinese medicines with anti-tumour effects, or immune-modulating treatments such as thymosin, interferon, or interleukin, within 2 weeks before the study start (except when used locally to manage fluid around the lungs)
• People who have had an active autoimmune disease requiring ongoing systemic treatment within the past 2 years (hormone replacement therapies for conditions like thyroid or adrenal insufficiency are not considered systemic treatment for this purpose)
• People who are currently receiving systemic steroid (glucocorticoid) therapy or any other immunosuppressive treatment within 7 days before the study start, unless the dose is very low (equivalent to 10 mg or less of prednisone per day); steroid sprays or inhalers are generally permitted (confirm with trial site)
• People who have had an organ transplant from a donor (except corneal transplants) or a bone marrow/stem cell transplant from a donor
• People who are known to be allergic to any of the drugs used in this study
• People who have significant nerve damage affecting the hands or feet (peripheral neuropathy at grade 2 or above)
• People known to have HIV infection
• People with active hepatitis B or hepatitis C, based on specific blood test results showing the virus is active
• People who received a live vaccine within 30 days before the study start — note that standard inactivated flu vaccines are generally permitted, but live nasal flu vaccines are not
• Women who are pregnant or breastfeeding
• People with any serious or poorly controlled medical conditions
• People with any other medical history, abnormal test results, or circumstances that the treating doctor considers would make participation unsafe or unsuitable

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