Artery Divestment Technique in Artery-Involved Pancreatic Cancer: A Single-Institution, Open-Labeled Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Overall mortality at one year after randomization;
研究概览
简要总结
Pancreatic cancer is the most lethal malignancy of human being. Surgery is the only potential cure of pancreatic cancer. The invasion of major abdominal arteries is one of the most important factor restricting surgical intervention. For artery-involved pancreatic cancer (ai-PC) patients, pre-operative adjuvant therapies, especially the neoadjuvant chemotherapy, has brought exciting postoperative survival. Yet due to the potential screening effect of this treatment strategy, nearly half of ai-PC patients failed to benefit from surgery because of disease progression, adverse reactions of adjuvant treatment and other reasons. Artery divestment for the treatment of ai-PC firstly reported by our center, can significantly increase resection rate and produce overall survival benefit in some patients. This study is to explore whether up-front surgery with artery divestment combined curative pancreatectomy or the chemotherapy-first strategy would be more beneficial for ai-PC patients' survival.
Subjects will be randomized to treatment group either receiving up-front artery divestment combined pancreatectomy (Surgery Group) or adjuvant chemotherapies (Chemo Group). In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status. In Chemo Group, adjuvant chemotherapy of gemcitabine or gemcitabine + cisplatin will be utilized according to performance status. After 2 circles of adjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
Overall mortality at one year after randomization will be the primary endpoint. Other parameters as overall survival after 2 and 3 years, median survival, disease-free survival, margin status of subjects receiving curative surgery, etc. will also be observed.
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
- •Diagnosed with pancreatic cancer staged at cT4NxM0(AJCC Cancer Staging Manual, 8th Edition) based on contrast enhanced CT&MRI scan and tumor markers;
- •Age > 18 year and <80 year;
- •Agree to participate in the study with signed informed consent.
排除标准
- •Evidence of metastasis based on physical examination, enhanced CT or enhanced MRI;
- •Poor performance status and/or co-morbidity precluding pancreatectomy and chemotherapy;
- •Focal vessel narrowing or contour irregularity revealed by radiology examinations;
- •Economic situations cannot afford designed treatment.
研究组 & 干预措施
Surgery Group
In Surgery Group, an artery divestment combined pancreatectomy will be performed if no pre-operative contra-indication or intra-operative metastasis were revealed. Post-operative adjuvant chemotherapies were prescribed according to performance status.
干预措施: Artery Divestment Technique (Procedure)
NeoChemo Group
In NeoChemo (Neoadjuvant Chemotherapy) Group, neoadjuvant chemotherapy will be utilized. After 2 circles of neoadjuvant chemotherapies, patients will be reevaluated and curative operation would be attempted if without disease progression.
干预措施: Nab-paclitaxel (Drug)
结局指标
主要结局
Overall mortality at one year after randomization;
时间窗: 1 year
次要结局
- Performance status at 2 years after randomization(2 years)
- Performance status at 3 years after randomization(3 years)
- Incidence of post-operative hemorrhage(1 years)
- Quality of life at 1 year after randomization(1 year)
- Incidence of surgical site infection(1 years)
- Margin status of subjects receiving curative surgery(1 years)
- Intra-operative blood transfusion(1 years)
- Quality of life at 2 years after randomization(2 years)
- Incidence of other surgical complications(1 years)
- Quality of life at 3 years after randomization(3 years)
- Overall survival rate after 2 years from randomization;(2 years)
- Overall survival rate after 3 years from randomization;(3 years)
- Median survival(3 years)
- Disease-free survival(3 years)
- Intra-operative blood loss(1 years)
- Overall surgical complication rate(1 years)
- Incidence of post-operative pancreatic fistula(1 years)
- Incidence of delayed gastric emptying(1 years)
- Performance status at 0.5 year after randomization(0.5 year)
- Severe adverse events rate(3 years)
- Quality of life at 0.5 year after randomization(0.5 year)
- Performance status at 1 year after randomization(1 year)
研究者
Yi Miao
Director of Pancreas Center
The First Affiliated Hospital with Nanjing Medical University