Phase I/II Study Evaluating the Safety and Efficacy of the HIFU Technique in Patients With Unresectable Pancreatic Tumor
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Tolerance profile of HIFU intervention
研究概览
简要总结
This is a phase I/II, multicenter trial for patients with locally advanced and unresectable pancreatic tumours :
- A Phase I evaluating the tolerance of intraoperative High Intensity Focused Ultrasound (HIFU) intervention on the pancreatic lesion.
- A non-randomized Phase II evaluating the preliminary efficacy of the HIFU intervention on the pancreatic lesion.
Patients included in Phase I will be monitored and included in the Phase II evaluation.
详细描述
The PULS study is designed for patients with a locally advanced tumour of the pancreas (known as pancreatic adenocarcinoma) that has previously been treated with several cycles of chemotherapy and cannot be removed by surgery.
Pancreatic adenocarcinomas are often diagnosed at an advanced stage and only 15% to 20% of patients are candidates for surgery to remove the tumour. In the remaining cases, around a third of patients have metastatic disease at the time of diagnosis. The remaining third have locally advanced pancreatic cancer. In these cases, chemotherapy with or without radiotherapy is the standard treatment. The low proportion of patients who can benefit from surgery and the poor response to chemotherapy make the development of new treatments vital and urgent.
For locally advanced cancers, we want to develop and evaluate a new form of treatment based on a medical device using high intensity focused ultrasound (HIFU), after chemotherapy.
HIFU is a recent technology that uses therapeutic ultrasound. All HIFU procedures currently performed are carried out using an extracorporeal approach.
The aim of this research is therefore to assess the safety and efficacy of HIFU ablation of locally advanced pancreatic tumours.
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 at the day of consenting to the study
- •Patient with histologically confirmed locally advanced (unresectable) pancreatic adenocarcinoma according to the National Comprehensive Cancer Network (NCCN) 2020 classification
- •Unifocal pancreatic lesion with a maximum diameter of 4 cm
- •Non-progressive disease after 4 months of first-line chemotherapy or after 2 months of chemotherapy in case of limiting toxicity contraindicating continuation of chemotherapy;
- •Preoperative imaging including CT-scan, MRI of the liver and Positron Emission Computed Tomography scan (PET-CT scan) (except for absolute medical contraindications), within 4 weeks prior to HIFU treatment
- •Eastern Cooperative Oncology Group performance status ≤ 2
- •Adequate hematologic parameters defined by platelets ≥ 100 Giga/l and hemoglobin ≥ 8 g/dl
- •Ability to understand and willingness for follow-up visits
- •Patient affiliated to a health insurance scheme (or beneficiary of such a scheme)
- •Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment
排除标准
- •Local recurrence of previously operated pancreatic cancer
- •Metastatic pancreatic carcinoma
- •History of major pancreatic resection
- •Chemotherapy completed less than 2 weeks ago
- •History of radiotherapy to the pancreas
- •Pregnant women
- •Possibility of R0 resection with venous reconstruction
- •Inability to undergo study follow-up for geographical, social or psychological reasons
- •Patient requiring tutorship or curatorship or patient deprived of liberty
- •Patient under psychiatric care against his wishes
研究组 & 干预措施
HIFU intervention
HIFU intervention
干预措施: HIFU intervention (Procedure)
结局指标
主要结局
Tolerance profile of HIFU intervention
时间窗: Up to 30 days after HIFU intervention
The tolerance of HIFU intervention will be assessed by the number of patients presenting at least one serious complication during the first 30 days after HIFU intervention. A serious complication corresponds either to any grade 3 or more complication according Clavien-Dindo classification or any vascular complication treated by interventional radiology
Survival rate at 12 months after HIFU intervention
时间窗: Up to 12 months after HIFU intervention
The efficacy of treatment will be assessed by the proportion of patients alive 12 months after HIFU treatment
次要结局
- Intra-operative and post-operative complications linked to the HIFU intervention(Up to 3 months after HIFU intervention)
- Feasibility of HIFU intervention(Up to 28 days after inclusion)
- Tumor ablation rate by HIFU(Up to 28 days after inclusion)
- Rate of secondary resectability(From date of HIFU intervention to the date of last patient's last visit, assessed up to 60 months)
- Clinical benefice rate regarding weight(From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.)
- Clinical benefice rate regarding performance status(From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.)
- Progression-Free Survival (PFS)(From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first or until the date of the last update for patients without progression, assessed up to 60 months after inclusion)
- Local Progression-Free Survival (local PFS)(From date of inclusion to the date of first disease progression or death or last update, assessed up to 60 months)
- Rehospitalization rate during the first 30 days after HIFU intervention.(From the date of HIFU intervention to 30 days after HIFU intervention)
- Incidence and severity of adverse events(From the date of intervention to the date of last patient's last visit, assessed up to 60 months.)
- Quality of Life (QoL)(From the date of inclusion to 6 months after HIFU intervention)
- Overall Survival (OS)(From date of inclusion to the date of death or date of last update, assessed up to 60 months)
- Length of hospitalization(From date of HIFU intervention to the date of discharge from hospitalization, assessed up to 3 months)
- Clinical benefice rate regarding pain(From the date of inclusion to the date of last patient's last visit, assessed up to 60 months.)