Phase II Study of Neoadjuvant Immunotherapy Plus Chemotherapy in Borrmann Type 4 and Large Type 3 Gastric Cancer (Neo-ICEBOAT Study)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- MPR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Tislelizumab (Drug)
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).
干预措施: Oxaliplatin (Drug)
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).
干预措施: S-1 (Drug)
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).
干预措施: Capecitabine (Drug)
结局指标
主要结局
MPR
时间窗: up to 2 years
Major pathologic response, defined as less than 10% residual tumor following neoadjuvant therapy
次要结局
- 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)
研究者
Haibo Qiu
MD
Sun Yat-sen University