Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) plus S-1 as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma (PDA).
详细描述
Advanced PDA is a lethal disease with a approximately 6 months of median survival. Gemcitabine is always the only approved single agent. The recent results of the phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and overall survival (OS) for the combination of nab-paclitaxel plus gemcitabine compared to gemcitabine alone. Thus, the combination of nab-paclitaxel with gemcitabine became one of a standard treatment in metastatic PDA. S-1 is an oral fluoropyrimidine, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer, and also demonstrated non-inferior, and even superior to gemcitabine as adjuvant chemotherapy. This single-arm study is to explore the efficacy and safety of nab-paclitaxel plus S-1 as first-line treatment in Chinese patients with local advanced or metastatic pancreatic ductal adenocarcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed-consent form.
- •Age no less than 18 years.
- •Histologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma, with RECIST measurable lesions.
- •Eastern Cooperative Oncology Group (ECOG) 0-1 with life expectation of no less than 12 weeks.
- •Patients must have received no previous chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatment with 5-fluorouracil or gemcitabine administered as a radiation sensitizer in the adjuvant setting is allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
- •Adequate liver/bone marrow function.
- •Human Chorionic Gonadotropin (HCG) test negative for female with contraception measure until 3 months after study end.
- •Compliant, and can be followed up regularly.
排除标准
- •Pregnant or breast-feeding female, or not willing to take contraception measures during study.
- •Serious infection requiring antibiotics intervention during recruitment.
- •Allergic to study drug.
- •More than grade 1 neuropathy.
- •Uncontrolled brain metastasis or mental illness.
- •Congestive heart failure, uncontrolled cardiac arrhythmia, etc.
- •Other malignancy within 5 years.
- •Can't be followed up or obey protocol.
- •Ineligible by the discretion of the investigator.
研究组 & 干预措施
nanoparticle albumin-bound paclitaxel, S-1
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycle: 6 cycles.
干预措施: nanoparticle albumin-bound paclitaxel (Drug)
nanoparticle albumin-bound paclitaxel, S-1
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycle: 6 cycles.
干预措施: S-1 (Drug)
结局指标
主要结局
Objective response rate
时间窗: Measure at every 6 weeks (every 2 cycles)
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
次要结局
- Overall survival(up to 2 years)
- Disease control rate(Measure every 6 weeks (every 2 cycles))
- Progression-free survival(up to 15 months)
- Safety and tolerability(up to 18 month)
研究者
Dai, Guanghai
Professor and chief physician
Chinese PLA General Hospital