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

RecruitingPhase 2Ages 18 Years - 75 YearsAllSun Yat-sen University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Tislelizumab
  • Oxaliplatin
  • S-1
  • Capecitabine
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Where

1 site
Sun Yat-sen University Cancer Center
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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