Phase 3 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 been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by laboratory testing of tissue samples.
• People aged 18 or older but under 75 years old — both men and women are eligible.
• People whose doctor has assessed them as suitable to receive pre-surgery treatment (neoadjuvant therapy) followed by an operation aimed at fully removing the cancer.
• People whose cancer can be staged using a specific internationally recognised cancer staging system (the 8th edition AJCC gastric cancer staging criteria).
• People who are able to provide a tumour tissue sample — either a fresh sample or a preserved tissue block or slides — taken within the 6 months before joining the trial.
• People with a good general level of physical functioning, as measured by a standard scale (ECOG score of 0 or 1), meaning they are fully active or have only minor limitations in daily activities (confirm with trial site).
• People who are expected to survive for at least 6 months.
• People whose blood test results show their organs and bone marrow are functioning adequately.
• Women who are not able to become pregnant, or women who can become pregnant and have a negative pregnancy blood test within 3 days before starting the study medication, and who are not breastfeeding. Both women who can become pregnant and men whose partners can become pregnant must agree to use contraception and avoid donating eggs or sperm from signing the consent form until 6 months after the last dose of the study drug.
• People who have agreed to take part by signing a consent form and are willing and able to attend visits, follow the study treatment plan, and complete required tests and procedures.

Who may not be able to join:

• People whose stomach cancer is of certain specific tissue types, including squamous cell carcinoma, undifferentiated carcinoma, or other less common types, or a mix of cancer types.
• People with certain types of cancer at the stomach–oesophagus junction that do not meet specific anatomical criteria, or whose cancer is not suitable for assessment under the standard staging system or for standard surgical approaches (confirm with trial site).
• People who have lost more than 20% of their body weight in the 2 months before joining the trial.
• People who have previously received any cancer treatment for their stomach or stomach–oesophagus junction cancer, including chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapies.
• People with a known allergy to any ingredient in the study drugs, including the investigational drug (adibelimab or placebo), tegafur, or oxaliplatin, or to similar antibody-based medicines.
• People who have been diagnosed with another cancer within the past 5 years, with some exceptions such as certain treated and cured skin cancers, early-stage bladder cancer, cervical carcinoma in situ, a non-invasive form of breast cancer, or a specific type of thyroid cancer.
• People with a history of immune system problems (including a positive HIV test or other immune disorders), organ or stem cell transplantation, or active autoimmune diseases that require ongoing treatment throughout the body — though some mild immune conditions or those managed with hormone replacement may not be excluded (confirm with trial site).
• People with severe wounds that have not healed, open wounds, active ulcers, or untreated broken bones.
• People with serious active diseases of the digestive system.
• People who have a lung condition involving scarring or inflammation of lung tissue (interstitial pneumonia or interstitial lung disease).
• People with serious heart, blood vessel, or metabolic conditions.
• People with active hepatitis B or hepatitis C infection at levels above specified thresholds, or a combined hepatitis B and C infection (confirm with trial site for specific test values).
• People who have had active tuberculosis within the past year, or who had tuberculosis more than a year ago that was not properly treated.
• People who had a serious infection within the 4 weeks before joining the trial.
• People with a known history of misusing or being dependent on drugs or substances that affect mental function.
• People who have other serious physical or mental health conditions, or abnormal test results, that in the treating doctor's judgement would make participation unsuitable or affect the trial results.

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