Phase II Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the Pancreas
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
详细描述
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.
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
- Single (Outcomes Assessor)
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
- •Histological or cytological confirmation of pancreatic adenocarcinoma
- •Distant metastatic or unresctable locally advanced diseases
- •CTScan (or MRI if scanner contraindicated) completed within 3 weeks of the start of treatment
- •At least one lesion measurable by RECIST v1.1 criteria
- •Life expectancy> 3 months
- •No previous chemotherapy (adjuvant chemotherapy with gemcitabine authorised if administered more than 6 months prior to inclusion)
- •No previous radiotherapy (unless at least one measurable target lesion outside the irradiation zone)
- •Pain must be monitored before inclusion
- •18 years < age < 70
- •Performance status: 0-1
- •ANC ≥ 1500/mm3, platelets ≥ 100 000/mm3, haemoglobin ≥ 9 g/dL
- •ASAT (SGOT), ALAT (SGPT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases found
- •Bilirubin ≤ 1.5 x ULN (patients drained by retrograde technique are includable),
- •creatinine < 120 μmol/L, or MDRD creatinine clearance > 60 mL/min
- •Patient information and signature of 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
S/nab
Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
干预措施: S1 or Gemcitabine (Drug)
Gem/nab
Nab-paclitaxel 125 mg/m² (D1, D8, q3w) and Gemcitabine 1000 mg/m² (D1, D8, q3w)
干预措施: S1 or Gemcitabine (Drug)
结局指标
主要结局
PFS
时间窗: 6 month
progression-free survival
次要结局
- OS(1 year)
- ORR(6 month)
- Safety profile :Adverse events of nab-Paclitaxel plus S-1(1 year)
- DCR(6 month)
研究者
Tao Zhang
Chief of Gastrointestinal Oncology
Wuhan Union Hospital, China