Active Anti-diabetic Treatment Plus Chemotherapy for Metastatic Pancreatic Cancer Related Diabetes Mellitus (Type 3c)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Overall Survival (OS):
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of anti-diabetic treatment on improving the overall survival for metastatic pancreatic cancer patients complicated by diabetes receiving gemcitabine and nab-paclitaxel chemotherapy.
详细描述
About 80% of patients with pancreatic adenocarcinoma have aberrant fasting blood glucose at the time of diagnosis. The consistent association between pancreatic cancer and diabetes mellitus has long been recognized and even been termed as "chicken and egg". Many reports have found that pancreatic cancer can result in diabetes, which is called type 3c diabetes. New-onset diabetes is commonly observed in pancreatic cancer patients and has been considered as a potential screening sign. Moreover, diabetes has been found as a predictor of poor outcome in pancreatic cancer.
Pancreatic cancer cells have a strong dependence on glucose and they are well-known for their sweet teeth. High glucose is associated with impaired immunologic reaction, intolerability to chemotherapy, radiotherapy and other major treatments, an increased risk of pancreatic surgery. Given the linkage between pancreatic cancer and diabetes or high blood glucose, a clinical trial is needed to validate the effect of anti-diabetic treatment in type 3c diabetes.
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
- •Ability to understand and the willingness to sign a written informed consent document.
- •Age ≥ 18 years and ≤ 80 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Histologically or cytologically confirmed metastatic pancreas adenocarcinoma.
- •History of diabetes mellitus, or newly diagnosed diabetes meeting the diagnostic criteria of the American Diabetes Association.
- •The expected survival ≥ 3 months.
- •Able to comply with study visit schedules and other protocol requirements.
排除标准
- •• History of other malignancies requiring anti-cancer therapy within 2 years prior to enrollment (except treated Stage I prostate cancer, in situ cervical cancer, in situ breast cancer, etc.);
- •Non-primary pancreatic cancer patients;
- •Digestive tract inflammation, including biliary tract infection, gastrointestinal infection, pancreatitis, etc.;
- •Pregnant or lactating women.
研究组 & 干预措施
Active anti-diabetic treatment
干预措施: Nab-paclitaxel (Drug)
Active anti-diabetic treatment
干预措施: Gemcitabine (1000 mg/m2) (Drug)
Active anti-diabetic treatment
干预措施: Anti-Diabetics (Other)
Active anti-diabetic treatment
干预措施: Active treatment and monitoring (Other)
Regular anti-diabetic treatment
干预措施: Nab-paclitaxel (Drug)
Regular anti-diabetic treatment
干预措施: Gemcitabine (1000 mg/m2) (Drug)
Regular anti-diabetic treatment
干预措施: Anti-Diabetics (Other)
结局指标
主要结局
Overall Survival (OS):
时间窗: 2 months
Time from randomization to death from any cause
次要结局
- Progression-Free Survival (PFS)(2 months)
- Blood Glucose Control(One month)
- Rate of HbA1c Control(One month)