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 are able to understand and voluntarily sign a written consent form before any study procedures begin.
• People who are 18 years of age or older at the time of signing the consent form, of any gender.
• People who have been confirmed by tissue testing to have a type of stomach or gastroesophageal junction cancer (adenocarcinoma) that does not have HER2 protein, is at a specific intermediate stage (Stage IIA to Stage III), and is considered removable by surgery (confirm with trial site for exact staging details).
• People who are willing to provide fresh blood, stool, and tumour tissue samples for testing, with samples of sufficient quality for analysis (repeated sampling may be required if initial samples are insufficient).
• People whose general physical functioning is rated as 0 or 1 on a standard medical scale, meaning they are fully active or have only minor restrictions on physically demanding activity.
• People whose expected survival is at least 3 months.
• People who have not previously received any anti-cancer treatments, including chemotherapy, radiation, targeted therapy, immunotherapy, or certain traditional Chinese medicines with known anti-cancer effects (diagnostic exploratory surgery is not counted).
• People whose blood counts, kidney function, liver function, and blood clotting levels meet the minimum thresholds required by the trial (confirm specific values with the trial site).
• Women of childbearing potential who have had a negative pregnancy blood test within 7 days before the first dose, and who agree to use effective contraception during the study and for 180 days after the last dose.
• Male participants whose partners could become pregnant, who agree to use effective contraception during the study and for 180 days after the last dose.

Who may not be able to join:

• People who received certain local cancer treatments, immune-boosting therapies, or Chinese herbal medicines with anti-cancer indications within 2 weeks before the first dose.
• People who have previously received immune checkpoint inhibitor treatments (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies), immune checkpoint activating therapies, or immune cell therapies targeting tumour immune mechanisms.
• People who have had a gastrointestinal perforation or fistula (a hole or abnormal opening in the digestive tract) in the 6 months before joining, unless it has been treated and the treating doctor determines the person has recovered.
• People with active or previously diagnosed inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), or who have difficulty swallowing, absorption problems, or uncontrolled nausea, vomiting, or diarrhoea that could seriously affect how medications are taken and absorbed.
• People who have had another active cancer in the past 3 years, except for the cancer being studied in this trial or certain localised cancers that have been fully treated and cured (such as certain skin cancers, superficial bladder cancer, or early-stage cervical, breast, or prostate cancers).
• People with known active or untreated cancer spread to the brain or surrounding membranes, spinal cord compression, or related conditions — unless specific conditions are met, including no symptoms after treatment, stable brain imaging for at least 4 weeks, and no use of steroids or anti-seizure medications for at least 2 weeks (confirm with trial site).
• People with fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month.
• People who have had an active autoimmune disease requiring systemic (whole-body) treatment within the 2 years before the study, or where the treating doctor believes the disease may return — with certain exceptions such as skin-only conditions not needing systemic treatment, stable thyroid conditions on hormone replacement, stable Type 1 diabetes on insulin, or childhood asthma that has fully resolved.
• People who have had certain serious heart or blood vessel events in the past 6 months, including heart attack, stroke, unstable chest pain, significant heart failure, or blood clots — or who have a known history of heart muscle disease, or have heart pumping function below a certain level (confirm specific thresholds with the trial site).
• People who have had deep vein blood clots or pulmonary embolism within the 3 months before joining.
• People with major blood vessel conditions that could be life-threatening or require surgery within 6 months (confirm with trial site).
• People with unresolved side effects from previous cancer treatments that have not returned to a mild or absent level, with some exceptions (confirm with trial site).
• People with moderate or severe nerve damage in the hands or feet (Grade 2 or higher on a standard scale).
• People with known symptomatic lung inflammation (interstitial lung disease or non-infectious pneumonia) that has required or currently requires systemic steroid treatment, and which the treating doctor believes could affect how side effects are assessed or managed.
• People with known active tuberculosis, or those suspected of having it who have not been properly assessed and cleared.
• People who have received systemic antibiotics or other anti-infective treatments (not including hepatitis B or C antiviral treatments) within 2 weeks before the first dose.
• People who have previously had an organ transplant or bone marrow/stem cell transplant from a donor.
• People with active coughing of blood, active infection or abscess in the abdomen, bowel blockage, or active inflammation of the intestinal wall pouches.
• People who have had significant bleeding symptoms or a known tendency to bleed within 1 month before joining, such as stomach bleeding or bleeding ulcers.
• People in whom internal examination has shown signs of active bleeding.
• People who have had a major surgery unrelated to the diagnosis of stomach cancer within 28 days before the first dose.
• People with untreated active Hepatitis B (with specific virus levels above set thresholds) or active Hepatitis C infection (confirm thresholds with trial site); people with Hepatitis B being treated with anti-viral medication during the study may be eligible (confirm with trial site).
• People known to have an immune deficiency condition or who are HIV positive.
• People with a known active syphilis infection.
• People currently taking part in another interventional clinical trial (non-interventional or observational follow-up studies may be acceptable — confirm with trial site).
• People who have needed systemic steroid or immunosuppressant treatment above a certain dose within 14 days before the first dose, with some exceptions such as low-dose, inhaled, topical, or eye-drop steroids, or steroids used to prevent infusion reactions (confirm with trial site).
• People who have received a live vaccine within 30 days before the first dose, or who plan to receive one during the study.
• People with a known history of severe allergic reactions to other monoclonal antibody treatments.
• People with a known mental illness or substance use disorder that could prevent them from meeting trial requirements.
• People with a known allergy or sensitivity to any of the drugs or their components used in this trial.
• People who are pregnant or breastfeeding.
• People where the treating doctor believes participation could pose a risk to their safety or affect the reliability of the study results.

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