Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer: A Pilot Single Arm Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Objective response rate（ORR）
研究概览
简要总结
Pancreatic cancer is a common malignancy of digestive system with gradually increasing incidence, is the fourth and seventh leading cause of cancer-related mortality in the world (1) and China (2) according to the statistics in 2014. The vast majority of patients were confirmed as locally advanced or distantly metastatic disease at diagnosis with an estimated five-year survival rate of 4% (3) due to occlusive development and rapid progress. Advanced pancreatic cancer is characterized by poor prognosis.
详细描述
Gemcitabine has been approved as the standard chemotherapy for advanced pancreatic cancer since 1996, but the efficacy is extremely limited by a response rate of 6-8%, and median survival of 5.5-7 months. However, Gemcitabine-based combination treatments fail to transcend GEM monotherapy on overall survival, including GEM + 5-Fu [10], GEM + Oxaliplatin[11], and GEM + Irinotecan [12] and GEM + Cisplatin [13] (7-8) . Until 2011, Conroy et al.[15] reported that FOLFIRINOX solutions significantly improved ORR (31.6% vs 9%, P=0.0008), PFS (6.4 vs. 3.3 months, P<0.0001) and OS (11.1 vs. 6.8 months, P<0.001) than GEM single-agent, but the significant increase of grade 3/4 adverse reactions, to some extent, limited its wide application. Therefore, it is necessary to continue to explore effective and safe chemotherapy of advanced pancreatic cancer.
Nab-Paclitaxel was approved by FDA for advanced pancreatic cancer in September 2013. S-1 has demonstrated potential value in the treatment of advanced pancreatic cancer as a new compound oral 5-FU(4-5) and has been approved for pancreatic cancer treatment in Japan.
We conducted a single arm, prospective, phase II study in our center on the first-line treatment of advanced pancreatic cancer with nab-Paclitaxel and S-1 to investigate the efficacy and safety of the combination regimen.
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
- •Age, years: 18-75
- •Histologically and cytologically confirmed advanced pancreatic cancer , inresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
- •Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
- •Laboratory examination within 14 days before entering the study should meet following requirements: ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
- •Both male and female subjects of potential fertility have to agree effective birth control during the entire study
- •Informed consent
排除标准
- •Concurrent other effective treatment (including radiotherapy)
- •Resectable patients
- •Allergy history to other drugs in the same class patients with pregnancy or lactation
- •Known severe internal medical diseases
- •Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
- •Immunocompromised patients, such as HIV positive
- •Uncontrollable mental illness
- •Other conditions the researchers considered ineligible for the study
研究组 & 干预措施
Nab-paclitaxel Plus S-1
Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)
干预措施: Nab-paclitaxel and S-1 (Drug)
结局指标
主要结局
Objective response rate（ORR）
时间窗: 6 month
CR+PR was defined as objective response rate (ORR)
次要结局
- OS(1 year)
- DCR(6 month)
- PFS(6 month)
- Safety profile: Adverse events of nab-Paclitaxel plus S-1 for advanced pancreatic cancer(1 year)
研究者
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences