NCT03483038进行中（未招募）2 期
A Phase II, Open-label Pilot Study Evaluating the Safety and Activity of Liposomal Irinotecan in Combination With 5-FU and Oxaliplatin in Preoperative Treatment of Pancreatic Adenocarcinoma (NEO-Nal- IRI Study)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery
研究概览
简要总结
This is a phase II, single arm, non-randomized, open label study of liposomal irinotecan with FOLFOX in the neoadjuvant setting in patients with resectable or borderline resectable, previously untreated pancreatic adenocarcinoma. The primary objective of this study is to investigate the safety and feasibility of this treatment regimen in this patient population.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be at least 18 years of age.
- •A new clinical diagnosis of resectable or borderline resectable, previously untreated pancreatic adenocarcinoma confirmed by pathologic specimen evaluation
- •No clinical evidence of metastatic disease
- •Potentially resectable local disease, as confirmed by CT or MRI of the abdomen
- •ECOG performance status of 0 or 1
- •Any biliary obstruction must have been treated.
- •Subjects with known or suspected Gilbert's disease must be formally tested for UGT1A1*28 with results available to study team prior to treatment initiation
- •Adequate organ function; as defined by:
- •i. Hematologic-
- •ANC > 1,500 cells/μl without the use of hematopoietic growth factors; and
- •Platelet count > 100,000 cells/μl; and
- •Hemoglobin > 9 g/dL (blood transfusions are permitted for patients with hemoglobin levels below 9 g/dL)
- •ii. Hepatic-
- •Serum total bilirubin within 1.5 x upper limit of normal (ULN) for the institution, with a trend downwards (biliary drainage is allowed for biliary obstruction),
- •AST and ALT less than or equal to 2.5 x ULN
- •iii. Renal- Serum creatinine less than or equal to 1.5 x ULN
- •iv. Cardiac- Normal ECG or ECG without any clinically significant findings as defined by the treating physician
- •Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for at least 7 months after the last dose of study drug to minimize the risk of pregnancy
- •Males with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 4 months following the last dose of study drug.
排除标准
- •A medical history of prior anti-cancer treatment for pancreatic cancer.
- •Locally advanced unresectable disease or evidence of metastatic disease.
- •Any other invasive malignancy within the past three years.
- •Presence of any known contraindications to or hypersensitivities to the investigational products.
- •Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to study entry.
- •A non-surgical candidate.
- •Subject is unable to understand, provide consent or comply with study requirements, treatments or instructions in the opinion of the treating physician.
- •Uncontrolled diarrhea, active infection, known interstitial lung disease or other medical condition that precludes safe administration of this combination therapy consistent with manufacturer recommendations.
- •Unwilling/unable to comply with birth control requirements while on study.
- •Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 7 months for females and 4 months for males after the last dose of study drug.
- •Females who are pregnant or breastfeeding.
- •History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
- •Prisoners or subjects who are involuntarily incarcerated.
- •Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
- •Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
- •Known dihydrypyrimidine (DPD) deficiency
研究组 & 干预措施
Liposomal irinotecan with FOLFOX
Experimental
Subjects will receive 8 cycles and each cycle is 14 days.
干预措施: Liposomal Irinotecan (Drug)
Liposomal irinotecan with FOLFOX
Experimental
Subjects will receive 8 cycles and each cycle is 14 days.
干预措施: FOLFOX regimen (Drug)
结局指标
主要结局
Percentage of Subjects Who Had Post-operative Complications 30 Days Post-surgery
时间窗: 30 days
To determine the percentage of subjects who had post-operative complications 30 days post-surgery. Post-operative complications considered for this outcome measure included hospital readmission, death, second surgery or interventional procedure, or major complications extending hospital stay.
次要结局
- Percentage of Subjects Who Completed All Intended Cycles of Treatment(4 months)
- Percentage of Subjects Who Achieved a Complete Surgical Resection (R0)(7 months)
- Percentage of Patients Achieving a Best Overall Response of Partial or Complete Response (Objective Response Rate)(5 months)
- Difference Between Baseline and Maximal Nadir of Serum CA19-9 Level(9 months)
- Subject Physical, Social, Emotional, and Functional Well-being During Treatment(Cycles 1, 5, and 8 and at pre-surgical evaluation and post-surgical follow-up visits)
研究者
研究点 (4)
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