A Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With Untreated Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 主要终点
- PFS
研究概览
简要总结
This is a Phase II , Open-label , Investigator-initiated Trail of Sequential GEMOX/NS Chemotherapy in Patients With untreated Pancreatic cancer.
This study aims to evaluate the safety and efficacy of Sequential GEMOX/NS Chemotherapy as a first-line treatment of untreated Pancreatic cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the trial and sign the informed consent form
- •18 years old <age <75 years old
- •Histopathological or cytologically confirmed (inoperable) locally advanced or recurrent metastatic pancreatic ductal adenocarcinoma with lesions measurable according to RECIST criteria
- •ECOG score 0-1
- •Life expectancy > 3 months
- •There must be a CT or MRI examination within a week
- •at least one lesion that can be measured by the RECIST v1.1 standard
- •No chemotherapy has been performed (the interval between postoperative adjuvant chemotherapy must be more than 6 months)
- •without radiation therapy (unless there is at least one measurable target lesion in the non-irradiated area)
排除标准
- •pregnant or lactating women; or those who have fertility but refuse to take contraceptive measures;
- •Severe active infections requiring intravenous antibiotic treatment during enrollment;
- •those who are allergic to the test drug;
- •There is ≥2 neuropathy (CTCAE 4.0);
- •uncontrolled, symptomatic brain metastases or those with a history of uncontrollable psychiatric disorders; severe intellectual or cognitive dysfunction;
- •Congestive heart failure, uncontrollable arrhythmia, myocardial infarction within 6 months, unstable angina, stroke or transient ischemic attack;
- •Have other malignant tumors within 5 years, except for fully treated cervical carcinoma in situ or squamous cell carcinoma of the skin, or basal cell carcinoma of the skin that has been basically controlled;
- •Patients who are unable to follow the protocol or who are unable to follow up;
研究组 & 干预措施
Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
干预措施: Albumin-bound paclitaxel (Drug)
Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
干预措施: S-1 (Drug)
Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
干预措施: Oxaliplatin (Drug)
Chemotherapy
Albumin-binding paclitaxel+S1 / gecitabine+oxaliplatin Interchanged every 2 cycles
干预措施: Gemcitabine (Drug)
结局指标
主要结局
PFS
时间窗: from the first drug administration up to 6 months
progression-free survival
OS
时间窗: from the first drug administration up to 1 year
overall survival
次要结局
未报告次要终点
研究者
Yanqiao Zhang
Director of the hospital
Harbin Medical University