Phase II Trial Comparing Nab-paclitaxel Plus S-1 Versus Nab-paclitaxel Plus Gemcitabine 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
- 40
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a randomized phase II trial comparing the first-line treatment with nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.
详细描述
Advanced pancreatic ductal adenocarcinoma (PDAC) is an aggressive and chemo-resistant disease with extremely low 5-year survival rate. Gemcitabine has been the cornerstone of metastatic PDAC treatment for more than a decade , although survival benefit was very poor. Nab-paclitaxel added to gemcitabine has showed improving survival and overall response rate vs gemcitabine alone in metastatic PDAC first-line treatment in the MPACT phaseIII study, which represents one of the standards of care in advanced PDAC therapy. S-1 is an oral 5-fluorouracil (5-FU) prodrug, and shown to be non-inferior to gemcitabine on OS for unresectable pancreatic cancer. Meanwhile, adjuvant chemotherapy with S-1 monotherapy was found to significant prolong survival of pancreatic cancer patients when compared with gemcitabine. This study is to explore the efficacy and safety of nab-paclitaxel plus S-1(AS) and nab-paclitaxel plus gemcitabine(AG) as first-line treatment in advanced pancreatic ductal adenocarcinoma (PDA) with primary tumor nonexcision in Chinese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 locally advanced or metastatic disease.
- •At least 4 weeks since completion of the last operation except for diagnostic biopsy.
- •At least 4 weeks since completion of radiotherapy to lesions.
- •Not suitable for local treatment.
- •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
- •Received chemotherapy or investigational therapy for the treatment of locally advanced or metastatic disease.
- •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
AS：Nanoparticle albumin-bound paclitaxel，S-1
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle.
S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
干预措施: nanoparticle albumin-bound paclitaxel (Drug)
AS：Nanoparticle albumin-bound paclitaxel，S-1
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle.
S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
干预措施: S1 (Drug)
AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
干预措施: nanoparticle albumin-bound paclitaxel (Drug)
AG：Nanoparticle albumin-bound paclitaxel，Gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21 day cycle.
干预措施: Gemcitabine (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 (RECIST)(every 3 cycles in AS or every 2 cycles in AG).
次要结局
- Overall survival(up to 2 years)
- Objective response rate of primary tumor(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)
- Disease control rate(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)
- Progression-free survival(up to 15 months)
- The incidence of treatment related emergent adverse events（Safety and Tolerance）(Until 28 days after the deadline of enrollment)
研究者
Shen Lin
Professor
Peking University