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 oesophagus (a specific area called the gastroesophageal junction), confirmed by a tissue sample (biopsy), where the cancer is mainly 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 surgery through the chest are eligible.
• People whose cancer has spread to nearby lymph nodes near the main blood vessel in the abdomen (called para-aortic lymph nodes), but not to other distant parts of the body, and whose surgical team has assessed that a complete surgical removal of the cancer (called R0 resection) is possible.
• People who have enlarged lymph nodes in a specific abdominal region (lymph node group No. 16), measuring 10 mm or more.
• People who have not previously had systemic (whole-body) treatment for their cancer, or people who received chemotherapy before surgery and whose cancer came back more than 6 months after completing that treatment.
• People with an expected survival of at least 6 months.
• People who have measurable tumour lesions that can be tracked according to standard measurement guidelines (called RECIST v1.1) (confirm with trial site).
• People who are in good general physical condition, rated as 0 or 1 on a standard activity scale used before surgery (called the ECOG performance status scale).
• People with good heart function who are medically suitable for surgery. People with known heart conditions may need an additional heart assessment before being considered.
• People whose blood test results meet the following health standards (without recent blood transfusions or certain medications affecting the results):
  • A sufficient level of infection-fighting white blood cells (neutrophils).
  • A sufficient number of platelets (cells that help blood clot).
  • A sufficient level of red blood cells (haemoglobin above 8 g/dL).
  • Liver function within acceptable ranges (bilirubin, AST, and ALT levels).
  • Kidney function within acceptable ranges (creatinine levels and kidney filtration rate).
  • Normal blood clotting ability (measured by INR or prothrombin time).
  • Thyroid hormone levels (TSH, FT3, FT4) within normal limits, or with only minor differences that the medical team considers unimportant.
  • Normal heart enzyme levels in blood tests, or only minor differences considered unimportant by the medical team.
• People weighing at least 40 kg, or with a body mass index (BMI) above 18.5.
• People who have read, understood, and signed a consent form agreeing to take part in the trial.

Who may not be able to join:

• People who have had another active cancer in the past 5 years, unless it was a fully treated localised cancer such as certain skin cancers, early-stage bladder, prostate, cervical, breast, lung, or bowel cancers.
• People who have previously had surgery on the upper abdomen (except keyhole surgery to remove the gallbladder).
• People who have previously had part of their stomach removed, or certain stomach procedures such as EMR or ESD (procedures to remove tissue from the stomach lining).
• People who need surgery for another condition at the same time as this trial.
• People who needed emergency surgery due to complications from their stomach cancer, such as bleeding, blockage, or a tear in the stomach.
• People who are preparing for or have previously had an organ or bone marrow transplant.
• People who had a blood transfusion within 2 weeks before surgery, or who have a bleeding disorder, or who experienced a serious bleeding event within 4 weeks before surgery.
• People with blood clotting problems or a tendency to bleed abnormally, or people taking blood-thinning medications such as warfarin or heparin (though low-dose warfarin of 1 mg daily or low-dose aspirin of up to 100 mg daily may be allowed if clotting levels are acceptable — confirm with trial site).
• People who have had a blood clot-related event such as a stroke, mini-stroke (TIA), deep vein thrombosis, or pulmonary embolism within 6 months before entering 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 long.
• People with severe heart failure (rated Class III or IV on a standard heart function scale called NYHA), or with significantly reduced heart pumping function on an echocardiogram (ultrasound of the heart).
• People with significantly reduced lung function based on breathing tests (FEV1 below 50% of the expected value).
• People with high levels of protein in their urine that are confirmed by a 24-hour urine test (above 1.0 g).
• People with fluid build-up in the chest or abdomen that is causing symptoms and needs medical treatment.
• People with HIV infection.
• People with active tuberculosis affecting the lungs.
• People with wounds that are not healing or bone fractures that have not fully healed.
• People with a history of certain lung conditions, such as interstitial lung disease, dust-related lung disease, or lung damage from radiation or medications.
• People with known active or suspected autoimmune diseases, unless the condition is stable and does not require immunosuppressive medication.
• People with severe chronic autoimmune conditions such as lupus, inflammatory bowel disease, Crohn's disease, sarcoidosis, or tuberculosis, or people with active hepatitis B or C. People with mild autoimmune conditions such as controlled psoriasis or arthritis may be eligible. People with hepatitis B with a low viral load (below 500 copies/ml) may be considered (confirm with trial site).
• People who need high-dose steroid treatment (more than the equivalent of 10 mg of prednisone per day) or other medications that suppress the immune system, within 14 days before surgery or during the study.
• People who have an active infection requiring antibiotic treatment within 14 days before surgery (excluding people taking preventive antibiotics for certain conditions).
• People who have received a live vaccine within 28 days before surgery (standard inactivated flu vaccines are generally not affected — confirm with trial site).
• People who are currently participating in another clinical trial involving surgical treatments.
• People with a current history of alcohol dependence, drug abuse, or substance misuse. People who have stopped drinking alcohol may be eligible.
• People who are unlikely to follow the trial's medical instructions or medication schedule, or whose records are incomplete in a way that could affect the reliability of the results.
• People who are pregnant or breastfeeding.
• People with other serious health conditions that the trial doctors consider would make participation unsafe or unsuitable.
• People the trial doctors determine, for any other reason, are not appropriate candidates for this trial.

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