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 have been confirmed by tissue or cell testing to have a specific type of stomach or gastroesophageal junction cancer (adenocarcinoma, including signet ring cell, mucinous, or hepatoid types)
• People whose cancer has been assessed by imaging and surgery as unable to be removed, or has returned or spread to other parts of the body
• People whose doctors expect them to live for more than 3 months
• People aged between 18 and 70 years old, of any gender
• People who have not yet received systemic treatment for advanced or metastatic stomach or gastroesophageal junction cancer — or, if they previously received adjuvant or neoadjuvant therapy (such as chemotherapy or radiation), that treatment must have finished at least 6 months before joining, with no sign of cancer returning at that time
• People whose general physical functioning falls within a certain level (ECOG score 0–1, meaning generally able to carry out daily activities — confirm with trial site)
• People who have at least one measurable area of cancer that can be tracked using standard imaging guidelines
• People who can provide stored or fresh tumour tissue samples taken within 6 months before signing consent, with test results available
• People whose major organ functions (blood, liver, kidneys, and clotting) meet specific laboratory test thresholds set by the trial
• People whose side effects from any previous cancer treatment or surgery have mostly or fully resolved
• Women of childbearing age who test negative for pregnancy within 3 days before starting the trial, and who agree to use highly effective contraception during the trial and for 3 months after the last dose
• Men whose partners could become pregnant, who agree to use effective contraception during the trial and for 3 months after the last dose, or who have had a surgical sterilisation procedure
• People who are willing and able to follow all scheduled visits, treatments, and tests as required by the trial, and who have signed an informed consent form

Who may not be able to join:

• People whose cancer is known to be HER2-positive
• People whose stomach cancer is a different tissue type, such as squamous cell, undifferentiated, or a mix of adenocarcinoma with other tissue types
• People who have active, uncontrolled cancer that has spread to the brain or spinal cord, with ongoing symptoms — though people with previously treated and stable brain metastases may be considered (confirm with trial site)
• People who have fluid build-up in the chest or abdomen that cannot be controlled by draining, or significant fluid around the heart, within 14 days before joining
• People who have lost more than 20% of their body weight in the two months before joining
• People who have had major surgery within 28 days before joining; received immunosuppressive drugs within 7 days before joining (with some exceptions); received a live vaccine within 28 days before joining; or received anti-cancer treatment within 28 days before joining
• People who have been diagnosed with another cancer within the past 3 years, with some exceptions such as certain early-stage or locally treated skin, cervical, breast, bladder, or thyroid cancers
• People who have an active or suspected autoimmune disease requiring systemic immune-suppressing treatment — though people with certain stable, well-managed conditions may be considered (confirm with trial site)
• People who have previously been treated with certain immune checkpoint drugs, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies
• People who have had significant bleeding, a gastrointestinal perforation or fistula, or a blood clot event (such as stroke, deep vein thrombosis, or pulmonary embolism) in the 6 months before joining
• People who have had a major blood vessel condition requiring surgery or treatment in the 6 months before joining
• People who have severe wounds, open ulcers, or untreated bone fractures that have not healed
• People who have nerve damage in their hands or feet rated above a mild level (grade 1 — confirm with trial site)
• People who have active symptoms of a bowel blockage at the time of joining (confirm with trial site regarding specific circumstances)
• People who have interstitial lung disease, uncontrolled systemic conditions such as poorly managed diabetes, high blood pressure, pulmonary fibrosis, or active pneumonia
• People who are known to be allergic to the study drug or its ingredients, or who have had severe allergic reactions to other similar antibody-based medicines
• People who have HIV infection or AIDS
• People who have active, untreated hepatitis B or hepatitis C infection meeting certain levels detected by blood tests, or a combined hepatitis B and C infection
• People who have had, in the past 6 months, a heart attack, severe or unstable chest pain, significant heart failure, serious heart rhythm problems, or symptomatic congestive heart failure
• People whose blood pressure remains poorly controlled despite medication (readings above 140/90 mmHg)
• People who have needed antibiotics for more than 7 days in the 4 weeks before joining, or who have had an unexplained fever above 38.5°C during the screening period
• People who have had an organ transplant or bone marrow/stem cell transplant from another person
• People who have participated in another clinical drug trial within 4 weeks before joining, or have not yet waited long enough since their last study drug dose (confirm with trial site)
• People with a known history of substance misuse or dependence
• People with serious physical or mental health conditions, or other abnormal test results, that the trial team considers would make participation unsafe or affect the trial results

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