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 able to understand and sign a consent form agreeing to take part
• People aged 18 to 75 years old, of any gender
• People who have been confirmed through a tissue biopsy to have stomach cancer or cancer of the junction between the stomach and food pipe (gastroesophageal junction), specifically the type called adenocarcinoma
• People with advanced stomach cancer that has spread only to lymph nodes near the main large blood vessel in the abdomen (para-aortic lymph nodes) at the time of first diagnosis, and whose main stomach tumour could potentially be removed with a major surgical procedure called D2 surgery
• People who have had a surgical exploration of the abdomen to confirm that the cancer has not spread to the lining of the abdomen, the liver, or other organs
• People whose scans (CT, MRI, or PET-CT) show that the only reason the cancer cannot be fully removed by surgery is the presence of those para-aortic lymph node deposits
• People who have not previously received any cancer treatment, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy
• People who have at least one tumour that can be measured on scans, according to standard research measurement guidelines (RECIST 1.1)
• People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity
• People whose doctors estimate they are likely to live for more than 3 months
• People whose blood test results show that their bone marrow, liver, kidneys, and blood clotting are functioning at adequate levels, specifically: white blood cell counts, platelet counts, and haemoglobin above certain thresholds without recent transfusions; liver enzyme and bilirubin levels within acceptable ranges; kidney function within acceptable ranges; blood clotting time within acceptable ranges; and thyroid hormone levels within normal ranges (confirm with trial site for specific values)
• Women who could potentially become pregnant must have a negative pregnancy test at the time of joining the trial
• People who could potentially become pregnant must be willing to use a highly reliable method of contraception during the trial and for a set period after the last dose of study medication (120 days after the last immunotherapy dose or 180 days after the last chemotherapy dose)

Who may not be able to join:

• People whose cancer tests positive for a protein called HER-2
• People whose cancer has spread to the lining of the abdomen or to other organs
• People who show signs of active bleeding in the stomach or gut on a camera examination (endoscopy), or who have had a hole or abnormal passage in the digestive tract within the 6 months before joining
• People who have been diagnosed with another type of cancer in the past 5 years, with the exception of certain skin cancers or early-stage cancers that have been fully removed
• People who are currently taking part in another clinical trial or who have received another experimental drug or medical device within the 4 weeks before starting this trial
• People who have previously received certain types of immunotherapy drugs that target immune checkpoint proteins (such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or similar treatments)
• People who have received certain Chinese herbal or immune-regulating medicines within the 2 weeks before starting the trial (confirm specific medicines with trial site)
• People who have had an active autoimmune disease requiring ongoing medical treatment within the past 2 years (routine hormone replacement therapies are generally not considered to fall under this exclusion — confirm with trial site)
• People who have been taking steroid tablets or other immune-suppressing medicines in the 7 days before starting the trial, except for low doses of steroids equivalent to 10 mg or less of prednisone per day, or steroid sprays and inhalers
• People who have had an organ transplant (other than a corneal transplant) or a stem cell transplant using cells from another person
• People who are known to be allergic to any of the study drugs: Sintilimab, Oxaliplatin, or S-1, or to their ingredients
• People who have difficulty taking medicines by mouth, or who have conditions that affect how the body absorbs or processes oral medicines, such as difficulty swallowing, previous removal of part of the digestive tract, ongoing severe diarrhoea, bowel obstruction, or blockages affecting eating or stomach emptying
• People who have not yet fully recovered from side effects or complications of a previous medical procedure before starting this trial (side effects should have returned to a mild level or back to normal, except for tiredness or hair loss)
• People who have HIV infection (confirmed by a positive HIV antibody test)
• People with uncontrolled active hepatitis B (confirm specific criteria with trial site, as some people with hepatitis B may still be eligible under certain conditions)
• People with active hepatitis C infection confirmed by blood tests
• People who have received a live vaccine within the 30 days before starting the trial (certain inactivated flu vaccines given by injection may be permitted — confirm with trial site)
• Women who are pregnant or currently breastfeeding
• People with serious or uncontrolled health conditions, including: significant heart rhythm problems or heart conduction abnormalities; unstable chest pain, heart failure, or moderate-to-severe chronic heart failure; a heart attack, stroke, or related event within the past 6 months; blood pressure that is not well controlled (above 140/90 mmHg); a history of lung inflammation requiring steroid treatment within the past year, or currently active lung scarring disease; active tuberculosis; active infections requiring ongoing treatment; active bowel inflammation, 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 testing; or a mental health condition that would prevent safe participation in the trial
• People with any other significant illness, mental health condition, or abnormal test result that the trial doctor considers would make participation unsafe or affect the reliability of the trial results

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