Prospective Single-Arm Feasibility Study to Determine the Capacity of the Onco-Seraph 100 Microbind® Affinity Blood Filter (Onco-Seraph 100) to Remove Circulating Tumor Cells From the Blood of Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0
研究概览
简要总结
This study is a Prospective Single Arm Open Label Feasibility trial to evaluate the initial safety and signal of efficacy of a novel extracorporeal blood purification (EBP) procedure in metastatic PDAC refractory to systemic therapy. Site selection will be dependent upon the site's familiarity with extracorporeal blood purification platforms as well as the diagnosis and management of PDAC. Adults (18 years old and older, ECOG PS of equal or less than 2) with a diagnosis of PDAC as defined histologically (microscopically) as a "pancreatobiliary type" adenocarcinoma with at least 5 U/mL CTCs in peripheral blood and/or portal vein.
详细描述
Study Intervention: All study patients will be assigned to receive treatment with the investigational device (Onco-Seraph 100).
Study Duration: Our target enrollment is 30 patients with PDAC. The study will last for up two years. Interim analyses will determine early stopping for safety. This is detailed in Section 23: Data Safety Monitoring Board (DSMB). Furthermore, as the safety and effectiveness of the experimental use of the ONCO Seraph 100 Microbind Affinity Blood Filter for treatment of patients with PDAC is unknown, patients will be followed for up to 5 years to inform oncological outcomes.
Procedure Setting: Extracorporeal blood purification utilizing Seraph can be performed either on an outpatient or an in-patient basis as HD/CRRT procedure is performed routinely in both settings. Whether the procedure will be performed in a setting of an outpatient or in-patient setting would mainly depend on the personalized approach that the Site Investigator choses related to individual patient enrolled in the study. Location of the Seraph treatment will be recorded, and data analysis will include consideration of the setting as it relates to study endpoints. If the Study Procedure is implemented in an outpatient setting subject will be monitored for additional 4 hours.
Procedure Duration for Onco-Seraph 100: A sufficient blood flow rate and exposure of patient's blood to the Onco-Seraph 100 adsorption media was initially established based on the experience in implementing procedure in patients with blood stream infections. However, target procedure duration is further optimized based on data collected in EU oncology patients as listed below:
The average procedure duration and blood flow rates targeted in patients with blood stream infections or oncology are as follows:
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
盲法说明
Unblinded
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
- •Patients ≥ 18 years of age with metastatic pancreatic ductal carcinoma who experienced disease progression or not tolerating fluoropyrimidine-, oxaliplatin- and irinotecan- based regimens or prior treatment with gemcitabine and nab-paclitaxel.
- •Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) scores of 2 or less.
- •Patient or legally authorized representative is willing and able to understand and provide a signed informed consent that fulfills the relevant IRB or Independent Ethics Committee (IEC) guidelines.
- •Patients with a CTC concentration of at least 5 cells/mL
- •Must be willing to provide blood samples for prospective tumor molecular profiling and exploratory analyses.
- •Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
- •Female patients must be of non-childbearing potential or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.
- •Female patients must have a negative serum pregnancy test at Screening, and negative urine pregnancy test at baseline prior to dosing.
- •Male patients must be surgically sterile or using a medically acceptable contraceptive regimen. Effective contraception includes surgical sterilization (e.g., vasectomy, tubal ligation), two forms of barrier methods (e.g., condom, diaphragm) used with spermicide, IUDs.
排除标准
- •Pregnant or breast feeding
- •Patients who cannot tolerate the placement of a dual lumen vascular access to enable extracorporeal treatment.
- •Patients with a history of heparin induced thrombocytopenia (HIT).
- •Patients with known allergy to heparin sodium.
- •High risk of bleeding (platelet count <50mm3 or International Normalized Ratio (INR) >1.5)
- •Hemodynamic instability and inability to tolerate extracorporeal procedure (defined as MAP<65 despite fluids and vasopressors and or sustained hypotension at enrollment as defined by two readings with systolic blood pressure (SBP) measurements below 100 mmHg or diastolic blood pressure (DBP) measurements below 50 mmHg. The measurements must be performed thirty minutes from one another, and the Subject must be resting for at least 5 minutes prior to obtaining each measurement. (If the first reading includes a SBP greater than 100 mmHg and a DBP greater than 50 mmHg, the second reading does not need to be taken.
- •Uncontrolled hypertension despite optimal management (systolic blood pressure >150 mmHg or diastolic pressure > 90mmHg).
- •Ongoing uncontrolled, serious infection.
- •Renal failure requiring dialysis.
- •Patients with a life expectancy of less than 30 days.
- •Pregnant and nursing women.
- •Participation in an investigational drug study or history of receiving any investigational treatment within 14 days prior to initiation of treatment on this study.
- •Concurrent participation in any interventional clinical trial or has been previously entered in this trial.
- •The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
- •Unable to obtain informed consent from either patient or legally authorized representative (LAR)
- •Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
结局指标
主要结局
Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0
时间窗: [Time Frame 30 days]
Incidence of treatment-emergent adverse events (AEs), graded using the NCI CTCAE Version 5.0.
Change in CTC Concentration
时间窗: [Time Frame 30 days]
The change in CTC concentration from baseline to the end of the induction series of Extracorporeal Procedure (ECPs) with Onco-Seraph 100.
Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells
时间窗: [Time Frame 60 days]
Capacity for the Onco-Seraph 100 filter to remove circulating tumor cells (CTCs) when compared to baseline.
Survival Follow-Up
时间窗: [Time Frame 60 days]
Survival Follow-Up (vital status)
Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0
时间窗: [Time Frame 30 days]
Incidence of treatment-emergent serious adverse events (SAEs), graded using the NCI CTCAE Version 5.0.
次要结局
- Incidence of Procedure-Emergent Serious Adverse Events Assessed by NCI CTCAE v5.0([Time Frame 60 days])
- Incidence of Procedure-Emergent Adverse Events Assessed by NCI CTCAE v5.0([Time Frame 60 days])
- Capacity for the Onco-Seraph 100 Filter to Remove Circulating Tumor Cells([Time Frame 30 days])