Clinical trial
Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
Name
2022-FXY-203
Description
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.
Trial arms
Trial start
2023-05-17
Estimated PCD
2024-11-01
Trial end
2027-11-01
Status
Recruiting
Phase
Early phase I
Treatment
Tislelizumab
Tislelizumab 200 mg will be administered systemically on day 1 of each cycle in all participants
Arms:
Tislelizumab + SOX/XELOX
Oxaliplatin
Oxaliplatin 150 mg will be administered systemically on day 1 of each cycle in all participants
Arms:
Tislelizumab + SOX/XELOX
S-1
S-1 40 mg will be administered orally on day 1-14 of each cycle in all participants
Arms:
Tislelizumab + SOX/XELOX
Capecitabine
Capecitabine 2500 mg will be administered orally on day 1-14 of each cycle in all participants
Arms:
Tislelizumab + SOX/XELOX
Size
53
Primary endpoint
MPR
up to 2 years
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 53, 'type': 'ESTIMATED'}}
Updated at
2024-06-11
1 organization
1 product
3 drugs
3 indications
Organization
Sun Yat-sen UniversityProduct
TislelizumabIndication
Stomach NeoplasmsIndication
Stomach CancerIndication
Linitis Plastica of StomachDrug
mFOLFOX6Drug
S-1Drug
AN0025