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Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer

Recruiting
18-75 years
All
Phase 2

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Overview

The aim of this study is to test the efficacy and safety of immunotherapy plus chemotherapy on people with a relatively rare type of gastric cancer. Participants will take the anti-PD-1 inhibitor (Tislelizumab) and platinum-based chemotherapy (oxaliplatin + capecitabine or oxaliplatin + S-1) in a 3-week cycle, followed by a radical operation after 6 cycles.

Eligibility

Inclusion Criteria:

  • Histologically confirmed gastric adenocarcinoma,cT1-2N+M0 or cT3-4NanyM0;
  • Males or females, aged 18-70 years;
  • Gastroscopy and abdominal computed tomography (CT) scan-confirmed typical scirrhous gastric cancer (borrmann type 4) or large type 3 (over 8 cm);
  • No peritoneal metastasis confirmed by laparoscopic exploration and with cytological examination of peritoneal washing of the Douglas pouch;
  • ECOG performance status 0 or 1;
  • Sufficient organ function:
    • white blood cell count \> 4\10\^9/L, neutrophil cell count \> 1.5\10\^9/L, hemoglobin \> 90 g/L, platelet count \> 100\*10\^9 /L
    • Serum bilirubin ≤ 1.5×upper limit of normal (ULN), AST, ALT ≤ 2.5×ULN
    • Creatinine ≤ 1.5 ×ULN or serum clearance \> 60 ml/min
    • INR and aPTT ≤ 1.5 × ULN, only for subjects not receiving anticoagulant therapy;Subjects undergoing coagulation therapy should use a stable dose
  • No prior anti-tumor therapy;
  • Have signed informed consent before the beginning of treatment.

Exclusion Criteria:

  • History of another malignancy within the last five years;
  • Previous cytotoxic chemotherapy, radiotherapy or immunotherapy
  • Unable to take drugs orally
  • Allergic to to any drug of the study regimen;
  • Women who are pregnant or breastfeeding or may be pregnant

Study details
    Stomach Neoplasms
    Gastric Cancer
    Linitis Plastica of Stomach

NCT06451211

Sun Yat-sen University

14 May 2026

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