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Trial Title:
Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
NCT ID:
NCT06451211
Condition:
Stomach Neoplasms
Gastric Cancer
Linitis Plastica of Stomach
Conditions: Official terms:
Stomach Neoplasms
Linitis Plastica
Capecitabine
Oxaliplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all
participants
Arm group label:
Tislelizumab + SOX/XELOX
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all
participants
Arm group label:
Tislelizumab + SOX/XELOX
Intervention type:
Drug
Intervention name:
S-1
Description:
S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
Arm group label:
Tislelizumab + SOX/XELOX
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all
participants
Arm group label:
Tislelizumab + SOX/XELOX
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510010
Country:
China
Status:
Recruiting
Contact:
Last name:
Haibo Qiu
Phone:
020-87343910
Email:
qiuhb@sysucc.org.cn
Start date:
May 17, 2023
Completion date:
November 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06451211
