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 aged 18 to 80 years, of any gender.
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and food pipe (called gastroesophageal junction cancer), confirmed by a tissue sample, where the cancer is mainly of a type called adenocarcinoma, and who have already received treatment before surgery (called neoadjuvant therapy). For junction cancers, only certain subtypes (Siewert Type II or III) that do not require chest surgery are eligible (confirm with trial site).
• People whose cancer has been assessed as stage III and is considered suitable for complete surgical removal, as determined by a surgeon and imaging specialist before joining.
• People who agree to have robotic-assisted surgery and whose surgeon finds no reason they cannot have it.
• People expected to live at least 6 months or more.
• People whose tumours can be measured using standard imaging criteria (called RECIST v1.1).
• People who are generally well enough to function independently or with only minor limitations before surgery, as measured by a standard scale called the ECOG score of 0 or 1.
• People with good enough heart function to safely undergo major surgery. Those with known heart conditions may need an assessment by a heart specialist beforehand.
• People whose blood test results meet all of the following: white blood cell counts, platelet counts, and haemoglobin levels are within acceptable ranges (without recent blood transfusions or certain medications); liver function, kidney function, and blood clotting results are within acceptable limits.
• People with normal thyroid function, or with only minor abnormalities that are not considered clinically significant.
• People whose heart enzyme levels are normal or have only minor abnormalities considered not clinically significant by the doctor.
• People who weigh at least 40 kg or have a body mass index (BMI) above 18.5.
• People who have read and signed the informed consent form for the trial.

Who may not be able to join:

• People who have had, or currently have, another cancer diagnosed within the past 5 years. (Exceptions may apply for certain early-stage or fully treated cancers such as skin cancers, early prostate, cervical, breast, bladder, lung, or bowel cancers — confirm with trial site.)
• People who have previously had surgery in the upper abdomen, except for keyhole (laparoscopic) gallbladder removal.
• People who have previously had part of their stomach removed, or certain endoscopic procedures to remove stomach tissue (EMR or ESD).
• People who need surgery for another condition at the same time.
• People who have had emergency surgery due to a complication of their stomach cancer, such as bleeding, blockage, or a tear in the stomach wall.
• People who are preparing for, or have previously had, an organ or bone marrow transplant.
• People who have had a blood transfusion within 2 weeks before surgery, have a known bleeding disorder, or have had a serious bleeding event within 4 weeks before surgery.
• People who have blood clotting problems or take blood-thinning medications such as warfarin or heparin. Low-dose warfarin (1 mg per day) or low-dose aspirin (up to 100 mg per day) for prevention may be allowed if blood clotting levels are within an acceptable range (confirm with trial site).
• People who have had a blood clot-related event such as a stroke, mini-stroke, deep vein clot, or lung clot within the 6 months before joining the trial.
• People who have had a heart attack or poorly controlled irregular heartbeat within 6 months before surgery, including those with a specific heart rhythm measurement (QTc interval) that is too high.
• People with moderate to severe heart failure, or whose heart pumping function (measured by a heart scan) is below 50%.
• People with significant breathing problems where a lung function test shows the lungs are working at less than 50% of expected capacity.
• People with significant amounts of protein detected in their urine.
• People who have a build-up of fluid around the lungs or in the abdomen that needs medical treatment.
• People with HIV infection.
• People with active tuberculosis affecting the lungs.
• People with wounds or broken bones that have not healed.
• People with a history of certain lung conditions (such as interstitial lung disease, radiation-related or drug-related lung damage) that could interfere with detecting treatment side effects.
• People with known active or suspected autoimmune diseases, unless the condition is stable and does not require immune-suppressing medication.
• People with severe autoimmune diseases such as lupus, inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), sarcoidosis, or active hepatitis B or C. People with hepatitis B who have a very low viral level may still be eligible (confirm with trial site). Milder autoimmune conditions such as controlled psoriasis or arthritis may be acceptable (confirm with trial site).
• People who need high-dose steroid tablets or other immune-suppressing drugs within 14 days before surgery. Low-dose steroids (up to 10 mg per day of prednisone or equivalent) used for non-immune reasons may be acceptable (confirm with trial site).
• People who have an active infection requiring antibiotic treatment within 14 days before surgery.
• People who have received a live vaccine within 28 days before surgery. Standard inactivated flu vaccines are generally acceptable.
• People currently enrolled in another clinical trial involving surgery-related treatments.
• People with a history of alcohol or drug misuse. People who have stopped drinking alcohol may be eligible.
• People who are unlikely to follow the study instructions or whose records are too incomplete to properly assess the trial's results.
• People who are pregnant or breastfeeding.
• People with other serious health conditions that the trial doctor believes would make participation unsafe.
• People considered unsuitable for any other reason, as judged by the trial doctor.

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