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 by laboratory testing to have a specific type of stomach or gastroesophageal junction cancer (where the stomach meets the oesophagus) that is locally advanced, including certain subtypes such as signet ring cell, mucinous, or hepatoid adenocarcinoma.
• People whose cancer has tested negative for a protein called HER-2.
• People aged 75 years or older.
• People with a general health status rated as 0, 1, or 2 on a standard medical scale (ECOG PS), meaning they are able to carry out daily activities to at least some degree (confirm with trial site).
• People who have at least one tumour that can be measured or assessed using standard imaging methods.
• People whose blood, liver, kidney, and heart function meet specific healthy ranges as assessed by blood tests (confirm with trial site for exact values).
• People whose thyroid hormone levels fall within a normal range, or whose additional thyroid tests are normal even if one measure is slightly outside the normal range.
• People who are expected to live for at least 12 weeks.
• People who are willing and able to give written consent and follow the trial's required visits and procedures.

Who may not be able to join:

• People with known signs of active bleeding from the tumour as seen on endoscopy.
• People whose tumour is causing a near-blockage at the top or bottom of the stomach that is affecting eating or the ability to swallow tablets.
• People whose cancer has tested positive for the HER-2 protein.
• People who have already received systemic treatment (such as chemotherapy or other drug therapy) for advanced or metastatic stomach or gastroesophageal junction cancer.
• People diagnosed with another cancer within the past 5 years, except for certain fully treated skin cancers or carcinoma in situ that was completely removed.
• People currently participating in another interventional clinical trial, or who have received another experimental drug or device within the 4 weeks before starting this trial.
• People who have previously received certain immunotherapy drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, or similar treatments that affect the immune system's T-cells (such as those targeting CTLA-4, OX-40, or CD137).
• People who have required systemic treatment for an active autoimmune disease within the past 2 years (note: certain replacement therapies such as thyroid hormone or insulin are not considered systemic treatment in this context).
• People who are currently taking systemic steroid (glucocorticoid) medications or other immune-suppressing drugs within 7 days before starting the trial, except for low-dose steroids at or below a specific threshold, or those applied locally via nasal spray or inhaler.
• People who have had an organ transplant (other than a corneal transplant) or a bone marrow/stem cell transplant from another person.
• People with a known serious allergic reaction (grade 3 or higher) to any monoclonal antibody or to any ingredient in the chemotherapy drugs used in this trial (including Tegretol or Capecitabine).
• People who have not yet recovered from side effects or complications of previous treatments (symptoms must be at grade 1 or lower, except for fatigue or hair loss).
• People with a known history of HIV infection.
• People with untreated, active hepatitis B with a detectable viral load above the laboratory's normal limit (people with hepatitis B who meet certain specific viral load and treatment criteria may still be considered — confirm with trial site).
• People with active hepatitis C infection, confirmed by a positive antibody test and a detectable viral level.
• People who have received a live vaccine within 30 days before starting the trial (note: standard injected inactivated flu vaccines are permitted, but live nasal flu vaccines are not).
• People with serious or uncontrolled medical conditions, including but not limited to:
  • Significant uncontrolled heart rhythm or electrical problems, such as certain types of heart block or irregular heartbeat.
  • Unstable angina, congestive heart failure, or chronic heart failure classified as grade 2 or higher on a standard heart failure scale.
  • A heart attack, stroke, or similar blood clot or circulation event within the 6 months before joining the trial.
  • Blood pressure that is not well controlled (above 140/90 mmHg).
  • A history of lung inflammation not caused by infection that required steroid treatment within the past year, or currently active interstitial lung disease.
  • Active tuberculosis.
  • An active or uncontrolled infection requiring systemic treatment.
  • Active diverticulitis, abdominal abscess, or bowel obstruction.
  • Serious liver disease such as cirrhosis or active hepatitis.
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L).
  • Significant protein in the urine confirmed by a 24-hour urine test showing more than 1.0 g of protein.
  • A mental health condition that would prevent the person from cooperating with treatment.
• People with any other medical history, condition, or test result that the trial investigators believe could interfere with the study or put the participant at risk.

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