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 are willing to take part voluntarily, have been fully informed about the study, and are willing and able to follow all trial procedures.
• People aged 18 to 80 years old (any gender).
• People who have been confirmed by imaging and tissue testing to have stomach cancer (gastric cancer) or cancer at the junction of the stomach and oesophagus that cannot be surgically removed, has come back and cannot be surgically removed, or has spread to other parts of the body — and whose cancer type is specifically adenocarcinoma (a type that starts in gland cells).
• People who have test results confirming that their cancer does not have high levels of a protein called HER2 (referred to as HER2-negative).
• People who have not previously received systemic (whole-body) treatment for advanced or metastatic stomach or gastroesophageal junction cancer. People who received earlier treatments before the cancer spread (such as chemotherapy or radiotherapy) may still be eligible if their cancer did not return or progress until more than 6 months after that treatment ended.
• People whose general physical fitness is rated 0 or 1 on a standard medical scale called the ECOG scale (meaning they are fully active or restricted in strenuous activity but can carry out light work).
• People who have at least one tumour that can be measured using standard imaging criteria.
• People whose side effects from any previous cancer treatment or surgery have largely resolved before joining the trial.
• People whose blood, kidney, liver, and clotting test results fall within the acceptable ranges required by the trial (confirm specific values with the trial site).
• People with a life expectancy of at least 3 months.
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and all participants must use effective contraception throughout treatment and for 6 months after treatment ends.

Who may not be able to join:

• People whose stomach or oesophageal cancer is a type other than adenocarcinoma (for example, squamous cell carcinoma or undifferentiated carcinoma).
• People who have had another active cancer in the past 2 years, with some exceptions for certain early-stage or fully treated skin cancers and similar conditions (confirm with trial site).
• People who have received another experimental drug, treatment, or medical device within 4 weeks before joining.
• People currently enrolled in another clinical trial that involves an active treatment (observational studies or completed interventional study follow-up periods may be acceptable — confirm with trial site).
• People who have untreated or uncontrolled cancer that has spread to the brain or spinal cord. People with fully treated and stable brain metastases may be considered if certain conditions are met (confirm with trial site).
• People who have fluid build-up around the lungs or in the abdomen that cannot be controlled, or significant fluid around the heart with symptoms.
• 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, received immune-suppressing medications within 14 days, received a live vaccine within 28 days, or had local cancer treatments such as radiotherapy within 28 days.
• People who have been diagnosed with another cancer in the past 5 years, with some exceptions for certain skin cancers, early cervical changes, early breast changes, and thyroid cancer treatable locally (confirm with trial site).
• People who have an active autoimmune disease (a condition where the immune system attacks the body's own tissues) that requires ongoing treatment. Some stable autoimmune conditions that do not need immune-suppressing drugs may be acceptable (confirm with trial site).
• People who have previously been treated with certain types of immunotherapy drugs that target immune checkpoints (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies).
• People who have had significant bleeding, a hole or tear in the stomach or bowel, or a blood clot in a vein or artery (such as a stroke, deep vein thrombosis, or pulmonary embolism) within the past 3 to 6 months (timeframes vary by condition — confirm with trial site).
• People who have had a serious blood vessel problem, such as an aortic aneurysm or arterial clot, within 6 months before joining.
• People with severe wounds, active ulcers, or broken bones that have not yet healed.
• People with nerve damage in the hands or feet rated worse than Grade 1 (mild).
• People who have had a bowel blockage within the past 6 months, or who currently show signs of bowel obstruction requiring ongoing feeding support (some exceptions may apply — confirm with trial site).
• People with lung inflammation or scarring (such as interstitial lung disease or pulmonary fibrosis), or other serious uncontrolled conditions such as uncontrolled diabetes or high blood pressure.
• People with a known history of active tuberculosis.
• People who are allergic to the study drug or its ingredients, or who have had a severe allergic reaction to another antibody treatment.
• People with HIV infection or AIDS, or with active, untreated hepatitis B or C (confirm specific test thresholds with trial site).
• People with serious heart conditions, including significant heart failure, unstable chest pain, a heart attack within the past 12 months, serious irregular heart rhythms, or an abnormal heart electrical reading above a certain level (confirm with trial site).
• 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 a bone marrow/stem cell transplant from a donor.
• People with a known history of misusing drugs or substances that affect mental state.
• People with other serious physical or mental health conditions that, in the opinion of the trial doctors, would make participation unsafe or unsuitable.

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