Phase 2 Trial of Gemcitabine vs S-1 vs Gemcitabine Plus Nab-paclitaxel as Adjuvant Chemotherapy of Post-operative Pancreatic Cancer Patients
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Disease free survival(DFS)
研究概览
简要总结
Pancreatic cancer is one of the deadliest tumor types, there is no effective treatment method clinically. Recently radical surgical resection is recommended for this cancer, How to improve the survival rate of patients is the doctors' goals . Postoperative chemotherapy can partly raise post-operative survival rate. the purpose of this study is to three chemotherapy regimens(gemcitabine monotherapy, S-1 monotherapy and combining nab-paclitaxel with gemcitabine),which is best regimens for raising patients' survival rate, and will provide a chemotherapy choice for clinic therapy of pancreatic cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed-consent form.
- •Man or woman aged 18 years to 80 years.
- •Histologically confirmed pancreatic carcinoma, and the histological type is ductal adenocarcinoma.
- •Mild (Child-Pugh A), moderate (Child-Pugh B) and some preferable severe (Child-Pugh C, <=10) hepatic dysfunction according to the Child-Pugh Scoring system criteria.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-3, with life expectation of no less than 12 weeks.
- •Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) ≥1.5 x 109/L; platelets ≥ 70 x 109/L; hemoglobin ≥ 8.0 g/dL.
- •Albumin ≥ 30 g/L.
- •Adequate hepatic function as evidenced by Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5 x upper limit of normal (ULN); Serum total bilirubin ≤ 1.5 x ULN; Serum creatinine ≤ 1.5 x ULN.
- •Females of childbearing potential must have a negative serum pregnancy test and must not breast-feed before the first dose. Male also need contraception.
- •Willing and able to comply with study procedures for the duration of the study.
排除标准
- •Hypertension, and unable to drop to normal level (systolic pressure >140 mmHg, diastolic pressure >90 mmHg) after treatment.
- •Patients have active cardiac disease including any of the following:
- •In resting state, average correction QTc > 470 msec on mean value of 3 times screening ECGs.
- •Any clinically significant abnormal ECG form, for example, complete left bundle branch block, 3-degree atrioventricular block, 2-degree atrioventricular block, or PR interval > 250 msec.
- •Any factors may increase the risk of QTc prolongation or arrhythmic event.
- •Left ventricular ejection fraction (LVEF) < 50%.
- •Patient weight still in losing period.
- •History of gastrointestinal bleeding or a gastrointestinal bleeding tendency, such as esophageal varices with high risk of bleeding, local active ulcerative lesions, fecal occult blood test>= (+ +) within the past 6 months, shall not enter the trial. If fecal occult blood test (+), the patient is requested for gastroscopy.
- •Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess within the past 28 days, should not enter the trial.
- •Patients with coagulant function abnormality (INR > 1.5 or prothrombin time (PT) > ULN + 4 sec), with bleeding tendency or are treated with thrombolytic or anticoagulant therapy.
- •Patients with unstable or serious concurrent medical conditions are excluded. The researcher evaluates that the patient who is not suitable for participation in the study. Patients with active infection, for example, HBV, HCV, or HIV.
- •Uncontrollable nausea, vomit, chronic gastrointestinal disorders leading to unable to swallow drugs, which may affect the fully absorption of S-
- •Patients with mental illness, or with psychiatric history of drug abuse.
研究组 & 干预措施
Nab-paclitaxel plus Gemcitabine
Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
干预措施: Nab-paclitaxel plus Gemcitabine (Drug)
Gemcitabine monotherapy
Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
干预措施: Gemcitabine monotherapy (Drug)
S-1 monotherapy
S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
干预措施: S-1 monotherapy (Drug)
结局指标
主要结局
Disease free survival(DFS)
时间窗: 3 years
To determine the DFS of post-operative patients with pancreatic cancer
overall survival time (OS)
时间窗: 5 years
To determine the OS post-operative patients with pancreatic cancer
median overall survival time (mOS)
时间窗: 5 years
To determine the mOS post-operative patients with pancreatic cancer
次要结局
- Objective Response Rate(ORR)(3 years)
- Quality of Life Assessment(3 years)
- safety profile(3 years)
- Disease control rate(DCR)(3 years)
研究者
Dabin Xu
Associate Chief Doctor
Chinese PLA General Hospital