Gastric or gastro-esophageal junction adenocarcinoma
Conditions
Interventions
Perioperative SOX/CapOX Combined with Serplulimab Treatment (Group A):Participants will first receive 4 cycles of neoadjuvant SOX/CapOX combined with serplulimab, administered once every 3 weeks (Q3W)
Perioperative SOX/CapOX Treatment (Group B):Participants will first receive 4 cycles of neoadjuvant SOX/CapOX, administered once every 3 weeks (Q3W). Imaging evaluations will be performed after the 2n
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients eligible for this study must meet all of the following criteria: 1. Fully understand and voluntarily sign the informed consent form (ICF). 2. Histologically confirmed gastric or gastroesophageal junction adenocarcinoma of Lauren classification intestinal type or mixed type, with clinical staging of II/III based on enhanced CT/MRI, classified as cT1-2N+M0 or cT3-4aNanyM0. 3. Agree to provide previously stored tumor tissue samples or undergo a biopsy to collect tumor lesion tissue for PD-L1, EBV, and MSI immunohistochemistry (IHC) testing at the central laboratory. 4. Gender unrestricted, aged between 18-75 years. 5. Good general condition, with an ECOG performance status of 0-1 and no surgical contraindications. 6. Physical status and organ function adequate to undergo major abdominal surgery. 7. Expected survival of = 3 months. 8. Laboratory test values within the following ranges within 7 days prior to enrollment: a. WBC > 4.0×10^9/L and 1.5×10^9/L, Hb = 80g/L, PLT = 100×10^9/L; b. Serum bilirubin = 1.5×upper limit of normal (ULN), AST, ALT = 2.5×ULN; c. Creatinine = 1.5×ULN or creatinine clearance rate > 60ml/min, calculated using the Cockcroft-Gault formula: (140 - age) × (weight in kg) × (0.85 if female) / 72 × (serum creatinine in mg/dL) or (140 - age) × (weight in kg) × (0.85 if female) / 0.818 × (serum creatinine in µmol/L) d. INR and aPTT = 1.5 × ULN for patients not on anticoagulation therapy; patients on anticoagulation therapy should be on a stable dose. 9. Good compliance and ability to cooperate with the study protocol's laboratory tests, auxiliary examinations, and specimen collection requirements. 10. Women of childbearing potential (including those who have become menopausal due to chemical or other medical reasons) must agree to use contraception from signing the informed consent form until at least 5 months after the last dose of study treatment or accompanying chemotherapy (whichever is later). Women must also agree not to breastfeed from signing the informed consent form until at least 5 months after the last dose of study treatment or accompanying chemotherapy (whichever is later). Men must agree to use contraception from the start of study drug administration until at least 7 months after the last dose of study treatment or accompanying chemotherapy (whichever is later).
Exclusion criteria
Exclusion criteria: Patients who meet any of the following conditions will not be eligible: 1. Known allergy to monohydrate citrate, disodium citrate, mannitol, or polysorbate (components of the investigational drug). 2. Concurrent or previous malignancies, except for completely resected basal cell carcinoma, Stage I squamous cell carcinoma, carcinoma in situ, mucosal carcinoma, superficial bladder cancer, or any other cancer that has been in complete remission for at least 5 years. 3. Uncontrolled pericardial effusion, pleural effusion, ascites, gastrointestinal bleeding, or high risk of bleeding within 2 weeks before enrollment. 4. Weight loss of more than 20% within 2 weeks before enrollment. 5. Inability to take oral medication. 6. History of chemotherapy, radiotherapy, immunotherapy, or surgery for gastric cancer. 7. Previous use of anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4 antibodies (or any other antibodies targeting T cell co-stimulatory or checkpoint pathways). 8. Receipt of tyrosine kinase inhibitor therapy within 2 weeks before enrollment. 9. Comorbidities requiring long-term immunosuppressive therapy or systemic or local corticosteroids at immunosuppressive doses (dose > 10 mg/day of prednisone or equivalent). 10. Receipt of any anti-infective vaccines (e.g., influenza vaccine, varicella vaccine) within 4 weeks before enrollment. 11. Uncontrolled systemic diseases such as diabetes or hypertension. 12. Current or required anticoagulant therapy (except for low-dose aspirin for antiplatelet therapy). 13. Any active autoimmune disease or history of autoimmune disease (including but not limited to: interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo or childhood asthma that has completely resolved and requires no intervention in adulthood may be included; patients with asthma requiring medical intervention with bronchodilators cannot be included). 14. Active tuberculosis (TB) or receiving anti-TB treatment, or having received anti-TB treatment within 1 year before screening. 15. History of any lung disease diagnosed by imaging (preferably CT) or clinical results, including interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, or acute lung disease. 16. Contraindications to the use of oxaliplatin, tegafur, or capecitabine. 17. Pregnant or breastfeeding women, or women who may become pregnant. 18. No active hepatitis. 19. Positive test results for any of the following: HIV-1 antibodies, HIV-2 antibodies, HTLV-1 antibodies, HCV antibodies. 20. Any other clinically significant disease or condition that, in the investigator's opinion, may affect protocol compliance, impact the patient’s ability to provide informed consent, or render the patient unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Pathological Response, pCR;Event-Free Survival, EFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor Regression Grade 0/1, TRG 0/1;R0 Resection Rate;Overall Survival, OS;Complete Pathological Response, pCR;Overall Survival in populations with CPS = 5 and CPS = 10;Event-free survival in patients with CPS = 5 and CPS = 10;Safety;Quality of Life; | — |
Countries
China
Contacts
Public ContactYuanfang Li; Shuming Yuan; Yongming Chen
Sun Yat-Sen University Cancer Center
Outcome results
None listed