Prospective Phase II Single-arm Study of Nab-paclitaxel and S-1 in Patients With Locally Advanced Pancreatic Cancer.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 6-month progression-free survival (PFS)
研究概览
简要总结
This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.
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
- •Patients have good compliance, can understand the research process of this study, and sign a written informed consent
- •Patients with pathologically confirmed pancreatic adenocarcinoma.
- •Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
- •Patients with locally advanced pancreatic cancer ( NCCN Version 1，2019 criteria).
- •ECOG PS 0-1;
- •Tumor size is measurable according to RECIST1.1 criteria
- •Expected survival over 3 months;
- •Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
- •Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
- •No contraindications to the use of S-1 and nab-paclitaxel.
排除标准
- •≥ Grade 2 existing peripheral neuropathy;
- •Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- •Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
- •Not able to take medicine orally.
- •Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
- •Participation in other clinical trial within 30 days before the first dose of the drug;
研究组 & 干预措施
nab-paclitaxel and S-1
chemotherapy of Nab-Paclitaxel and S-1, repeat 21 days for up to 8 cycles. The following treatment including pancreatectomy, continuing same chemotherapy, S-1 maintenance therapy, or radiotherapy will be decided after discussion between physicians and patients.
干预措施: Nab-paclitaxel and S-1 (Drug)
结局指标
主要结局
6-month progression-free survival (PFS)
时间窗: 6 months
The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.
次要结局
- Objective Response Rate (ORR)(From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.)