Phase II Single-arm Trial of Nab-Paclitaxel and S-1 as Neoadjuvant Treatment of Patients With Resectable Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
There were limited data for nab-paclitaxel and S-1 in pancreatic cancer. To explore the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with resectable pancreatic cancer (stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions ), we designed this study. This study was a single-arm single center prospective phase II clinical study. A total of 72 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1 prior to pancreatectomy. Response was reported according to the Response Evaluation Criteria in Solid Tumors guidelines (RECIST, version 1.1) .The primary endpoint is objective response rate. The secondary endpoints include R0/R1 resection rate, disease free survival, overall survival and safety.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed-consent form;
- •Treatment-naive PDAC with histological or cytological diagnosis;
- •Resectable pancreatic cancer stage II and partial stage III defined according to the National Comprehensive Cancer Network definitions;
- •Age≥18 years old and ≤70 years old;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •BMI≥18.5 and NRS2002score<3;
- •Expected survival over 3 months;
- •Spared organ function satisfying the following laboratory data:leucocyte≥3.0x109/L,neutrophils≥1.5x109/L, hemoglobin≥ 9g/dL, platelets ≥100x109/L, total bilirubin ≤ 1.5 ULN; AST and ALT≤ 2.5 ULN; serum creatinine≤1.5ULN; PT and INR≤ 2.5 ULN;
排除标准
- •Severe Impaired organ functions;
- •Patients who had surgeries, chemotherapy or other treatments before inclusion;
- •Pregnant women or lactating women;
- •Ineligible by the discretion of the investigator.
研究组 & 干预措施
nab-paclitaxel and S-1
neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 2-4 cycles
干预措施: Nab paclitaxel and S-1 (Drug)
结局指标
主要结局
Objective response rate
时间窗: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 24 months
Percentage of patients who achieve partial response (PR) or complete response(CR) based on Response Evaluation Criteria In Solid Tumors (RECIST1.1)
次要结局
- Overall survival(From date of randomization until the date of death from any cause or censored at the last day that the patient is documented to be alive, whichever came first, assessed up to 24 months)
- R0/R1 resection rate(2 years)
- Disease free survival(From date of randomization until the date of first documented progression or metastasis, assessed up to 12 months)