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Clinical Trials in China / NCT06451211
Recruiting Phase 2

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

NCT06451211 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2023-05-17
Last updated
2024-06-11

Condition(s) studied

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)

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting

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Official registry record

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.

View NCT06451211 on ClinicalTrials.gov ↗ ← All trials in China