Phase II Trial of Nab-paclitaxel Plus Gemcitabine in First-line Treatment of Chinese Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Overall 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 gemcitabine as first-line treatment in Chinese patients with advanced pancreatic ductal adenocarcinoma.
详细描述
Advanced pancreatic ductal adenocarcinoma is a fatal disease with about 6 months of median overall survival (OS). Gemcitabine is the only approved single agent. Gemcitabine-based chemotherapy did not show benefit in OS during the past decade. The recent phase III trial MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) demonstrated an improvement in overall response rate (ORR), progression free survival (PFS) and OS, with nab-paclitaxel (125 mg/m2 on day 1, 8 and 15 every 28 days) plus gemcitabine (1000 mg/m2 on day 1, 8 and 15 every 28 days) compared to gemcitabine alone. Accordingly the combination of nab-paclitaxel with gemcitabine became one of standard treatments in metastatic pancreatic cancer. A Chinese phase II trial showed the modified dosage of nab-paclitaxel (120 mg/m2 on day 1 and 8 every 21 days) plus gemcitabine (1000 mg/m2 on day 1 and 8 every 21 days) is more suitable for Chinese patients. This study aims to explore the efficacy and safety of the tentative dosage of nab-paclitaxel (125 mg/m2 on day 1 and 8, every 21 days) and gemcitabine (1000 mg/m2 on day 1 and 8, every 21 days) for Chinese patients.
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, gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, each 21-day cycle. Number of cycle: 6 cycles.
干预措施: nanoparticle albumin-bound paclitaxel (Drug)
nanoparticle albumin-bound paclitaxel, gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 and 8, in combination with gemcitabine which is given at 1000 mg/m2, on day 1 and 8, each 21-day cycle. Number of cycle: 6 cycles.
干预措施: gemcitabine (Drug)
结局指标
主要结局
Overall response rate
时间窗: Measure at every 6 weeks (every 2 cycles) up to 18 weeks
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
- Progression-free survival(up to 15 months)
- Overall survival(up to 2 years)
- Disease control rate(Measure every 6 weeks (every 2 cycles) up to 18 weeks)
- Safety and tolerability(up to 18 month)
研究者
Liu, Rong
Professor and chief physician
Chinese PLA General Hospital