Gastric cancer
Conditions
Interventions
Perioperative Gastric Cancer Patient:CAPEOX+Tislelizumab
Healthy Volunteer:No Intervention
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 75 years, regardless of gender; 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma, classified as cT3–4aN1–3M0 according to the 8th edition of the AJCC staging system, and assessed as surgically resectable based on imaging evaluation; 3. No prior antitumor therapy; 4. Willingness to provide tissue samples for examination (for PD-L1 expression testing, single-cell transcriptome sequencing, etc.); 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =6 months; 7. Adequate hepatic, renal, and bone marrow function, meeting the following laboratory criteria: (1) Total bilirubin =60 mL/min; (4) Serum albumin >=30 g/L (3.0 g/dL); (5) Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) =75,000/mm^3; hemoglobin >=9 g/dL; absolute neutrophil count >=1,500/mm^3; 8. For female participants: must be surgically sterile, postmenopausal, or agree to use a medically approved contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study treatment period and for 6 months after its completion. A negative serum pregnancy test within 7 days prior to study drug administration is required, and participants must not be breastfeeding; 9. Voluntarily agree to participate and sign a written informed consent form, with willingness and ability to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1. Previous systemic therapy for gastric cancer; 2. Patients with microsatellite instability–high (MSI-H) gastric cancer; 3. Stage IV (metastatic) or unresectable gastric cancer as determined by the investigator, or the presence of another active malignancy within the past 1.5 years or concurrently; patients with cured localized malignancies such as basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast may be enrolled; 4. Patients who are scheduled for or have previously undergone organ or bone marrow transplantation; 5. Myocardial infarction or uncontrolled arrhythmia (including QTc interval >=450 ms for males or >=470 ms for females, calculated by Fridericia’s formula) within 6 months prior to enrollment; 6. New York Heart Association (NYHA) class III–IV heart failure or left ventricular ejection fraction (LVEF) 10 mg/day prednisone-equivalent dose) or other immunosuppressive therapy within 14 days prior to enrollment or during the study period; however, patients may be enrolled if they are receiving topical or inhaled corticosteroids, or adrenal replacement therapy at =140 mmHg and/or diastolic blood pressure >=90 mmHg despite optimized medical therapy, or unstable conditions resulting from acute complications of hypertension (such as hypertensive crisis or hypertensive encephalopathy); 19. Tumor lesions with a tendency to bleed (e.g., active ulcerative tumor lesions with positive fecal occult blood test, history of hematemesis within 2 months prior to signing the informed consent, or presence of a high risk of gastrointestinal bleeding as determined by the investigator), or receipt of a blood transfusion within 2 weeks prior to study drug administrati
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major pathological response rate;R0 resection rate;Safety;Tolerability; | — |
Countries
China
Contacts
Public ContactHu Jiankun
West China Hospital, Sichuan University
Outcome results
None listed