Actively Recruiting
Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
Led by Sun Yat-sen University · Updated on 2024-06-11
53
Participants Needed
1
Research Sites
232 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed gastric adenocarcinoma, cT1-2N+M0 or cT3-4NanyM0
- Male or female aged 18 to 70 years
- Gastroscopy and abdominal 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 cytological exam of peritoneal washing
- ECOG performance status 0 or 1
- Adequate organ function including white blood cell count > 4x10^9/L, neutrophil count > 1.5x10^9/L, hemoglobin > 90 g/L, platelet count > 100x10^9/L
- Serum bilirubin ≤ 1.5x upper limit of normal, AST and ALT ≤ 2.5x upper limit of normal
- Creatinine ≤ 1.5x upper limit of normal or serum clearance > 60 ml/min
- INR and aPTT ≤ 1.5x upper limit of normal for subjects not on anticoagulant therapy; stable dose required if on anticoagulant therapy
- No prior anti-tumor therapy
- Signed informed consent before treatment
You will not qualify if you...
- History of another malignancy within the last five years
- Previous cytotoxic chemotherapy, radiotherapy, or immunotherapy
- Unable to take drugs orally
- Allergic to any drug in the study regimen
- Women who are pregnant, breastfeeding, or may be pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510010
Actively Recruiting
Research Team
H
Haibo Qiu, MD, Ph.D
CONTACT
C
Chao Ding, MD, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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