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

Summary

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

Conditions4

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