Selective Transvenous Chemoembolization of Primary Pancreatic Tumors
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
研究概览
简要总结
Catheter directed retrograde venous infusion of gemcitabine/lipiodol into pancreatic tumors.
详细描述
Overall, subjects with resectable, borderline-resectable and/or locally-advanced pancreatic cancer are eligible to be entered into the study. Each enrolled study subject will receive a single neoadjuvant pancreatic retrograde venous infusion (PRVI) administration of the gemcitabine/Lipiodol® emulsion.
Complete enrollment in 12 months from date of enrollment of first study subject.
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
- •Age ≥ 18 years
- •Pathologically and radiologically-confirmed pancreatic adenocarcinoma confined to the pancreas with initial diagnosis within 8 weeks of consent
- •Resectable, borderline-resectable or locally-advanced primary pancreatic adenocarcinoma per NCCN guidelines
- •The patient is deemed a candidate for the study by the Johns Hopkins Multidisciplinary Pancreatic Tumor Board
- •Preserved liver function (Child-Pugh A-B class) without significant liver decompensation
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at study entry
- •Measurable or evaluable disease that will be directly treated with intra-pancreatic therapy (as defined by Response Evaluation Criteria in Solid Tumors [RECIST 1.1]
- •Suitable for PRVI, based on blood parameters such as platelet count, LFTs including bilirubin and coagulation status including international normalized ratio (see "Exclusion Criteria" below)
- •The patient is able to give informed consent
- •The patient, if a woman of childbearing potential, has a negative pregnancy test
- •The patient is willing and able to comply with study procedures, scheduled visits, and treatment plans
- •Life expectancy of at least 3 months
排除标准
- •Serum total bilirubin > 3.0 mg/dL
- •Creatinine > 2.0 mg/dL
- •Platelets < 75,000/μL
- •Hgb < 8.0 g/dl
- •ANC ≤ 1,000/μL
- •INR > 2.0
- •Complete portal vein thrombosis or significant cavernous transformation of the portal vein
- •Ascites (trace ascites on imaging is OK)
- •The patient is pregnant or breast-feeding
- •The patient is allergic to contrast media that cannot be readily managed or prevented with premedication
- •Patients with peripheral neuropathy [> grade 1, according to the National Cancer Institute Common Toxicity Criteria v5.0 (CTAE v5.0)]
研究组 & 干预措施
Pancreatic adenocarcinoma
Participants with resectable, borderline-resectable or locally-advanced pancreatic adenocarcinoma will receive pancreatic retrograde venous infusion of gemcitabine/lipiodol
干预措施: Retrograde venous infusion of gemcitabine/lipiodol (Drug)
结局指标
主要结局
Feasibility as determined by technical success of Pancreatic Retrograde Venous Infusion (PRVI) with gemcitabine and Lipiodol®
时间窗: 30 days
Technical success is measured as number of participants who did not experience technical failure, which is defined as the inability to administer the gemcitabine/ Lipiodol® to the targeted pancreatic tumor.
Safety as measured by number of participants with Grade 3, 4, and 5 toxicities
时间窗: 30 days
Number of participants with Grade 3, 4, and 5 toxicities as defined by the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE; Version 5.0) that occur during and within 30 days after PRVI
次要结局
- Efficacy as assessed by Objective tumor response(30 days)
- Efficacy as assessed by change in levels of gemcitabine and dFdu in peripheral blood samples(Change from baseline to 30 days)
- Efficacy as assessed by change in serum CA19-9(Change from baseline to 30 days)