Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji in Unresectable Pancreatic Ductal Adenocarcinoma Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Technical success for device feasibility
研究概览
简要总结
This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.
详细描述
Study Title An Open-label, Non-randomized, Single-center Study Investigating the Feasibility, Safety, Tolerability and Efficacy of Suizenji, an Ultrasound-guided HIFU Therapy System, in Patients with Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II) Objectives Primary objectives
- To evaluate the safety and tolerability of Suizenji. Secondary objectives
- To evaluate the overall performance of Suizenji.
- To explore technical success and preliminary clinical efficacy of Suizenji. Trial Stages Feasibility study Investigational site Stanford Cancer Institute Study Design This is an open-label, non-randomized, single-center study.
The study will consist of:
- A screening period
- HIFU treatment procedure(s) and post-HIFU assessments
- Initiation of 1st line chemotherapy
- Follow-up visits at Month 1 and Month 3
- Long-term follow-up visits until death or up to 5 years Subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments.
All eligible subjects will be enrolled in the study and will receive HIFU treatment on Day 1. An additional session will be required prior to the initiation of chemotherapy if one of the following; (1) ablation is not completed as planned, or (2) insufficiently ablated per PI's discretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Signed an Institutional Review Board (IRB) approved informed consent document.
- •Men and women ≥ 18 years of age.
- •Histologically or cytologically diagnosed PDAC.
- •Newly diagnosed unresectable*, locally advanced or metastatic disease. (* defined as not "Resectable" and not "borderline resectable" based on "Criteria Defining Resectability at Diagnosis" in NCCN Guideline 2024)
- •Primary tumor accessible to HIFU treatment and visualized on transabdominal ultrasonography.
- •Primary tumor site must be a measurable lesion according to RECIST version 1.1 at baseline.
- •ECOG Performance Status (ECOG-PS) of 0 -
- •Life expectancy ≥ 3 months.
- •Adequate organ function defined by:
- •Neutrophil count: ≥ 1,500/mm3
- •Platelet count: ≥ 50,000/mm3
- •Hemoglobin: ≥ 8.0 g/dl
- •Cr: ≤ 1.7 mg/dl
- •AST, ALT: ≤ 3 x upper limit of normal
- •T-Bil: ≤ 2 x upper limit of normal
排除标准
- •Subjects with any cancers other than PDAC who are on active treatment.
- •Subjects who had any prior chemotherapy or interventions for PDAC.
- •Obstructive jaundice (except for subjects who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
- •Tumor embolization in the veins surrounding the pancreas.
- •Cysts outside of primary pancreatic tumor which may obstruct the HIFU sonication pathway. However, if the cyst is completely surrounded by pancreatic tumor, the subject can be included.
- •Subjects with > 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI scan.
- •Allergy to contrast agents (except when manageable by prophylactic steroid).
- •Subjects having a cardiac pacemaker.
- •Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months.
- •Subjects with peritoneal dissemination.
- •Active infections requiring systemic treatment.
- •Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding.
- •Received unapproved or investigational drug or device within 30 days of the subject's study start date.
- •The judgment of the investigator would make the subject inappropriate for entry into the study.
研究组 & 干预措施
Suizenji (an ultrasound-guided HIFU therapy system)
Suizenji (an ultrasound-guided HIFU therapy system)
干预措施: Suizenji (an ultrasound-guided HIFU therapy system) (Device)
Suizenji (an ultrasound-guided HIFU therapy system)
Suizenji (an ultrasound-guided HIFU therapy system)
干预措施: Nal-IRI/FL (Drug)
Suizenji (an ultrasound-guided HIFU therapy system)
Suizenji (an ultrasound-guided HIFU therapy system)
干预措施: mFOLFIRINOX adjuvant chemotherapy (Drug)
Suizenji (an ultrasound-guided HIFU therapy system)
Suizenji (an ultrasound-guided HIFU therapy system)
干预措施: Gem/nab-PTX (Drug)
结局指标
主要结局
Technical success for device feasibility
时间窗: 3 Months
Technical success of the HIFU ablation defined as \> 50% of treated volume assessed by MRI and/or contrast-enhanced CT after the last HIFU. Change from Baseline.
次要结局
- Disease Control Rate(3 months)
- Tumor Marker(3 months)
- FDG-PET(3 months)
- Tumor volume(3 Months)
- Clinical Efficacy(3 Months)
- Immune responses(3 months)
- Numerical Rating Scale (NRS)(3 months)