Phase 2 Stomach Cancer Trial, Recruiting

Written by an AI model from the 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 have been confirmed (through a tissue or cell sample) to have adenocarcinoma of the stomach or where the stomach meets the food pipe (gastroesophageal junction), including certain subtypes such as signet ring cell, mucinous, or hepatoid adenocarcinoma.
• People whose cancer has spread to other parts of the body (metastatic disease), confirmed through scans or surgery.
• People who are expected to live more than 3 months.
• People aged between 18 and 75 years.
• People who have not previously received any anti-cancer treatments such as chemotherapy, radiation, targeted therapy, or immunotherapy — OR who completed adjuvant or neoadjuvant therapy (treatment given before or after a main treatment) at least 6 months before joining the trial, with no cancer recurrence or progression during that treatment.
• People who have completed palliative (symptom-relieving) radiotherapy at least 2 weeks before the first study treatment.
• People who stopped taking anti-tumour traditional Chinese medicine at least 2 weeks before joining.
• People with a good general health and activity level, rated 0 or 1 on the ECOG scale (meaning fully active or able to carry out light work) (confirm with trial site).
• People who have at least one measurable tumour lesion, as defined by standard imaging guidelines (RECIST 1.1).
• People who have a tissue sample (archived or freshly collected within the past 6 months) that is sufficient for a PD-L1 test, with results available.
• People whose blood counts, liver function, kidney function, and blood clotting results meet specific minimum levels set by the trial (confirm with trial site for exact values).
• People who have not received any systemic treatment in the 6 months after their tissue sample was collected for the trial.
• People whose side effects from any previous cancer treatment or surgery have largely resolved (to a low or minimal level).
• People who are using reliable contraception methods during the trial.
• People who have read and signed an informed consent form and are willing and able to attend all required visits and follow study procedures.

Who may not be able to join:

• People whose cancer tests positive for HER2 (a specific protein marker found in some cancers).
• People whose stomach cancer is not adenocarcinoma — for example, squamous cell carcinoma, undifferentiated carcinoma, or mixed types.
• People with active, uncontrolled cancer that has spread to the brain or spinal cord, or who have symptoms related to brain metastases.
• People with uncontrolled fluid build-up around the lungs or in the abdomen that required drainage in the 14 days before joining, or significant fluid build-up around the heart.
• People who have lost more than 20% of their body weight in the 2 months before joining.
• People who have had major surgery within 28 days before joining (routine diagnostic biopsies and port placements are generally allowed).
• People who have taken immunosuppressive medications within 7 days before joining (low-dose steroids or nasal/inhaled steroids may be allowed — confirm with trial site).
• People who have received a live vaccine within 28 days before joining, during the study, or within 60 days after treatment ends.
• People who have received any anti-cancer treatment (such as chemotherapy, radiotherapy, or targeted therapy) within 28 days before joining.
• People who have been diagnosed with another cancer within the past 3 years, except for certain early-stage or fully treated cancers such as basal cell skin cancer, early bladder cancer, cervical cancer in situ, early breast ductal cancer, or papillary thyroid cancer.
• People with an active, known, or suspected autoimmune disease (some stable conditions that do not require immune-suppressing medication may be allowed — confirm with trial site).
• People with uncontrolled epilepsy, a condition affecting red blood cells called congenital spherocytosis, claustrophobia, or a type of glaucoma called angle-closure glaucoma.
• People who have previously been treated with certain immunotherapy drugs, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
• People who have had significant bleeding, a gastrointestinal perforation or fistula (abnormal opening) in the 6 months before joining, or a blood clot event such as a stroke, deep vein thrombosis, or pulmonary embolism in the past 6 months.
• People who have had major blood vessel disease, such as an aortic aneurysm or recent arterial blood clot, within the past 6 months.
• People with serious wounds that have not healed, active ulcers, or untreated broken bones.
• People with nerve damage in their hands or feet worse than a mild level (greater than Grade 1 peripheral neuropathy — confirm with trial site).
• People who have had a bowel obstruction or related symptoms within the past 6 months (those who had surgery to fix a partial blockage at the time of their original diagnosis may still be considered).
• People with interstitial lung disease, non-infectious lung inflammation, or other uncontrolled conditions such as uncontrolled diabetes, high blood pressure, pulmonary fibrosis, or active pneumonia.
• People with known severe allergies to the study drugs or to any monoclonal antibody treatments.
• People living with HIV or AIDS.
• People with untreated active hepatitis B or hepatitis C, or infection with both at the same time.
• People who have had a heart attack, severe chest pain (unstable angina), moderate to severe heart failure, significant irregular heart rhythms, or congestive heart failure within the past 6 months.
• People with poorly controlled high blood pressure despite medication (blood pressure consistently above 140/90 mmHg).
• People who have needed antibiotics for 7 or more days within the past 4 weeks, or who have an unexplained fever above 38.5°C at the time of screening.
• People who have previously had an organ transplant or stem cell transplant from a donor.
• People who are currently participating in another clinical drug trial, or who received a study drug within the past 4 weeks or within 5 half-lives of that drug (whichever is longer — confirm with trial site).
• People with a history of substance abuse or drug addiction.
• People with any other serious physical or mental health condition, abnormal test results, or other concerns that the trial doctor considers would make participation unsafe or affect the results.
• People with certain lung conditions, including a previously treated collapsed lung (pneumothorax), severe emphysema, or large air blisters on the lungs (pulmonary bullae).

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