A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection
研究概览
简要总结
The objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed and histologically-confirmed PDAC by biopsy
- •Permanent street address
- •Consent to study participation
- •Axial CT scan consistent with PDAC
- •No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
排除标准
- •Male or female patients < 18 years of age
- •No permanent street address or telephone number
- •Pregnant patients
- •Inmates or prisoners
- •Unable to provide informed consent
研究组 & 干预措施
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
干预措施: Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) (Device)
Neoadjuvant chemotherapy (NAC) plus endoscopic ultrasound (EUS) radiofrequency ablation (RFA)
干预措施: Neoadjuvant Chemotherapy (NAC) (Drug)
结局指标
主要结局
Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection
时间窗: From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)
次要结局
- Disease-free survival time(from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first))
- Number of participants with post-operative complications(from the time of surgical tumor resection to 90 days following surgical tumor resection)
- Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria(4 months after the initiation of chemotherapy)
- Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria(2 months after the initiation of chemotherapy)
研究者
Nirav C Thosani
Associate Professor
The University of Texas Health Science Center, Houston