Gastric Cancer, Linitis Plastica of Stomach, Stomach Neoplasms
Conditions
Brief 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.
Interventions
DRUGTislelizumab
Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants
DRUGOxaliplatin
Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants
DRUGS-1
S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
DRUGCapecitabine
Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MPR | up to 2 years | Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | up to 2 years | — |
| Incidence of surgical complications | up to 2 years | — |
| Rate of R0 resection | up to 2 years | — |
| OS | up to 5 years | 3-year overal survival |
| DFS | up to 5 years | 3-year disease-free survival |
Countries
China
Contacts
Primary ContactHaibo Qiu, MD, Ph.D
Backup ContactChao Ding, MD, Ph.D
Outcome results
None listed