Stomach NeoplasmsGastric CancerLinitis Plastica of Stomach
Investigational drug(s) / intervention(s)
TislelizumabOxaliplatinS-1Capecitabine
Tislelizumab: Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants
Oxaliplatin: Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants
S-1: S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
Capecitabine: Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants
Study 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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
MPR — up to 2 years Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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