Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
Overview
- Phase
- Phase 2
- Intervention
- Tislelizumab
- Conditions
- Stomach Neoplasms
- Sponsor
- Sun Yat-sen University
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- MPR
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Haibo Qiu
MD
Sun Yat-sen University
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
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
Arms & Interventions
Tislelizumab + SOX/XELOX
Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1).
Intervention: Tislelizumab
Tislelizumab + SOX/XELOX
Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1).
Intervention: Oxaliplatin
Tislelizumab + SOX/XELOX
Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1).
Intervention: S-1
Tislelizumab + SOX/XELOX
Patients with borrmann type 4 or large type 3 (over 8 cm) gastric cancer, who are deemed to be surgically resectable, are treated with neoadjuvant Tislelizumab (200 mg) and oxaliplatin (150 mg) intravenously on day 1 plus capecitabine (2500 mg) or S-1 (40 mg) orally on day 1-14 in each 21-day cycle. Radical gastrectomy will be performed after 6 cycles, followed by adjuvant chemotherapy (capecitabine or S-1).
Intervention: Capecitabine
Outcomes
Primary Outcomes
MPR
Time Frame: up to 2 years
Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy
Secondary Outcomes
- Incidence of surgical complications(up to 2 years)
- Adverse Events(up to 2 years)
- DFS(up to 5 years)
- Rate of R0 resection(up to 2 years)
- OS(up to 5 years)