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 who have given written consent to take part in the study voluntarily
• People whose cancer has been confirmed by a tissue or cell sample (biopsy) as adenocarcinoma (a specific type of cancer) of the stomach or the area where the stomach meets the oesophagus (gastroesophageal junction)
• People whose cancer has been assessed by CT or MRI scan and is at a stage where it has grown significantly into the stomach wall or spread to nearby lymph nodes, but has not spread to distant parts of the body (confirm with trial site for exact staging details)
• People aged 18 to 75 years old, of any gender
• People who are generally well enough to carry out light daily activities — this is measured using a standard medical scale called ECOG performance status 0–1 (confirm with trial site)
• People who have not previously received any treatment for this cancer, including radiation, chemotherapy, or surgery
• People for whom surgery is planned after the pre-surgery treatment phase, with the expectation that all visible cancer can be removed
• People whose life expectancy is estimated to be at least 6 months
• People whose blood, liver, kidney, and clotting function test results fall within the acceptable ranges set by the trial (confirm with trial site for specific values)
• Women who could become pregnant must have a negative pregnancy test within 72 hours before starting the trial, and must use effective contraception during the trial and for at least 120 days after the last dose; male participants whose partners could become pregnant must either be surgically sterilised or agree to use effective contraception during the trial and for 120 days after the last dose
• People who are willing and able to attend follow-up appointments and cooperate with the study requirements
• People who agree to provide a tumour tissue sample for testing

Who may not be able to join:

• People whose cancer cannot be surgically removed, or who are unable or unwilling to have surgery
• People who have already received, or are currently receiving, any anti-cancer treatment such as radiation, chemotherapy, or immune checkpoint inhibitor drugs (a type of immunotherapy)
• People who have been taking immunosuppressant drugs or high-dose steroid medications (above a certain dose) within 2 weeks before starting the trial — some low-dose or topical steroid use may be allowed (confirm with trial site)
• People who have received a live vaccine within 4 weeks before starting the trial, or who would need one during the study or within 120 days after the last dose
• People who had a serious infection requiring hospitalisation within 4 weeks before starting the trial, or who show signs of an active infection or needed antibiotic treatment within 14 days before starting (preventative antibiotic use may be allowed — confirm with trial site)
• People who have an active autoimmune disease currently requiring treatment, or a history of an autoimmune disease that could come back — some exceptions may apply (confirm with trial site)
• People with a known history of immune system deficiency, HIV, other immune conditions, or who have had an organ transplant or bone marrow transplant from a donor
• People with poorly controlled heart conditions, including moderate-to-severe heart failure, unstable chest pain (angina), a heart attack within the past year, certain abnormal heart rhythms, or abnormal electrical readings on a heart test (ECG) above set limits
• People with active tuberculosis (TB) of the lungs, or a history of TB that was not properly treated
• People with heart-related risk factors that could cause dangerous changes in heart rhythm, such as a genetic heart condition, a family history of sudden unexplained death under age 40, or certain medications affecting heart rhythm
• People with active hepatitis B or hepatitis C infections above certain levels
• People with nerve damage in their hands or feet rated as moderate or severe (grade 2 or above)
• People who have been diagnosed with another cancer within the past 5 years — some very low-risk skin cancers or pre-cancerous conditions that have been fully treated may be allowed (confirm with trial site)
• People with a known history of severe allergic reactions to monoclonal antibody drugs, or a known allergy to any of the specific study drugs used in this trial (QL1706, oxaliplatin, or Tegur/Tigor)
• People with a known enzyme deficiency called dihydropyrimidine dehydrogenase deficiency, which affects how certain chemotherapy drugs are processed by the body
• People who have a blockage in the upper digestive tract, or a condition that affects how food or medication is absorbed
• Women who are pregnant or breastfeeding
• People who are currently enrolled in another clinical trial that involves an active treatment intervention
• People whom the trial doctor determines may not be able to safely or reliably complete the study, for reasons such as serious mental health conditions, substance use, or significant social or personal circumstances

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