Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
Sun Yat-sen University
53 participants
May 17, 2023
INTERVENTIONAL
Conditions
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 Criteria12
- 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 Criteria5
- 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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Interventions
Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants
Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants
S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06451211