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 given written consent to take part in the study
• People aged 18 to 75 years old
• People who have been confirmed by tissue testing to have stomach cancer or cancer of the junction between the stomach and food pipe that cannot be surgically removed and has either spread locally or to other parts of the body, and whose cancer did not respond to or stopped responding to a first standard treatment
• People who are reasonably active and able to care for themselves, based on a standard performance scale (rated 0–2 out of 5, where lower is better)
• People who are expected to live for at least 6 months
• People who have at least one tumour that can be measured on scans, according to standard measurement guidelines (RECIST 1.1)
• People whose blood and organ function results meet specific minimum standards — including healthy enough levels of blood cells, liver enzymes, kidney function, clotting ability, and heart enzymes — tested within 7 days before starting the study, without recent use of blood products or growth factors (confirm with trial site for exact values)
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose
• All participants with the ability to have children must use highly effective contraception (with a failure rate below 1%) during treatment and for 120 days after the last study drug dose, or 180 days after the last chemotherapy dose

Who may not be able to join:

• People diagnosed with another cancer (other than stomach cancer) in the past 5 years, except for certain cured skin cancers or early-stage cancers treated with the intent to cure
• People whose scans show the tumour is wrapped around major blood vessels or has large areas of tissue breakdown, creating a risk of bleeding, as judged by the doctor
• People currently taking part in another interventional clinical study, or who received an experimental drug or device within the past 4 weeks
• People who have needed systemic (whole-body) treatment for an active autoimmune disease within the past 2 years (hormone replacement-type therapies are not considered systemic treatment for this purpose)
• People who have been taking steroid tablets or injections, or other immune-suppressing medications, within the 7 days before starting the study (nasal sprays, inhalers, or topical creams are not included in this restriction)
• People who have had an organ transplant or bone marrow/stem cell transplant from another person (corneal transplants are not included)
• People with a known allergy to any medication used in this study
• People who have not yet recovered from side effects or complications of previous treatments (side effects must be mild or back to their normal baseline level, except for tiredness or hair loss)
• People known to have HIV infection
• People with untreated active hepatitis B, defined as having a positive hepatitis B surface marker and detectable virus levels in the blood
• People with active hepatitis C infection, meaning hepatitis C antibodies are present and the virus is detectable in the blood
• People who have received a live vaccine within 30 days before the first dose (standard injected flu vaccines are allowed; nasal spray flu vaccines are not)
• People who are pregnant or breastfeeding
• People with serious or uncontrolled health conditions, including:
  • Significant heart rhythm problems that are hard to control
  • Unstable chest pain, or moderate-to-severe heart failure
  • A heart attack, stroke, or related event within the past 6 months
  • Blood pressure that is not well controlled (above 150/100 mmHg)
  • Lung inflammation that required steroid treatment within the past year, or current active lung disease of that type
  • Active tuberculosis
  • Any active or uncontrolled infection needing medication
  • Active bowel inflammation, abdominal abscess, or a blocked bowel
  • Liver conditions such as cirrhosis, liver failure, or active hepatitis
  • Poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
• People with any other condition, illness, or abnormal test result that the study doctor believes could interfere with the trial, affect the person's ability to take part fully, or create additional health risks

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