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Recruiting Phase 2 NCT06496789

Neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer

Trial Parameters

Condition Gastric Adenocarcinoma
Sponsor Tianjin Medical University Cancer Institute and Hospital
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-05-27
Completion 2024-12-30
Interventions
Serplulimab+SOX

Brief Summary

evaluate efficacy and safety of neoadjuvant Serplulimab in Combination With Chemotherapy in Locally Advanced Gastric or Gastro-esophageal Junction Cancer

Eligibility Criteria

Inclusion Criteria: * histologically documented adenocarcinoma of Gastric or Gastroesophageal Junction. 2. clinically diagnosed stage T3-4aN+M0 according to ultrasound endoscopy or enhanced CT/MRI scan. 3. Male or female. Age ≥ 18 years and ≤75 years. 4. surgeons participating in this study consider the lesion a resectable one. 5. ECOG 0\~1 6. Physical condition and adequate organ function to ensure the success of abdominal surgery. 7. Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥90g/L. 8. Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN . ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L. 9. Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 60 ml/min. 10. Adequate coagulation function: INR/PT≤ 1.5 x ULN, aPTT≤ 1.5 x ULN. 11. No serious concomitant disease that will threaten the survival of patients to less than 5 years. 12. W

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