An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Treatment effect by radiology
研究概览
简要总结
Thermotherapy is a technology aiming at destroying tissue, for example tumor tissue. Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response. In laboratory animals the imILT method has also been shown to induce a so called abscopal effect. This means that when one tumor is treated with imILT other, untreated, tumors also decrease in size.
The purpose of this trial is to evaluate efficiency when it comes to local tumor destruction of the imILT treatment method performed pecutaneously in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety of the method.
This trial is an open-label, double-arm study. Twenty patients diagnosed with pancreatic cancer will be treated in this trial, ten recieving imILT treatment and ten recieving standard chemotherapy. The study is estimated to be carried out during a time period of 21 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of non-resectable pancreatic adenocarcinoma by form of either locally advanced disease (stage II-III) or of stage IV disease with hepatic metastasis (staging according to UICC 2009)
- •Locally advanced disease shall have a lesion diameter less than 4cm
- •If stage IV disease, the patient shall have only liver metastasis, with less than 5 in number, each one less than 4 cm in diameter
- •The patient is a candidate for standard chemotherapy (as described at point 5.1)
- •Age between 18 and 80 years, males and females
- •Anticipated compliance with treatment and follow-up
- •Have given informed verbal and written consent to participation in the trial
- •Have stable and adequate haematologic, renal and hepatic functions:
- •Hemoglobin ≥9 g/dL
- •Platelet count ≥75 x 109/L
- •International normalized ratio (INR) ≤1.7
- •WBC count ≥2 x 109/L
- •Absolute neutrophil count (ANC) ≥1 x 109/L
- •Albumin ≥2.8 g/dL, total bilirubin ≤3.0 mg/dL (51.3 μmol/L); ALT, AST ≤5 times upper limit of normal (ULN)
- •Serum chemistries sodium, potassium, and calcium within normal limits (WNL)
- •Serum creatinine <2.0 mg/dL or creatinine clearance >60 mL/min according to Cockroft-Gault formula
- •At least a part of the tumour can be treated with imILT without damage to adjacentvital structures
- •Have an ECOG performance status <2 (Karnofsky> 60%)
排除标准
- •HIV 1 or 2 positive
- •Active autoimmune disease which is judged to reduce an anti-tumour immune response
- •Pregnancy or breast feeding
- •Have known bleeding disorder that cannot be managed accordingly with the protocol rules, such severe acute or chronic liver failure, other genetic blood diseases not properly managed prior to treatment or other any disease treated with anticoagulant or anti-platelet medication that cannot be interrupted prior to treatment
研究组 & 干预措施
imILT treatment
Immunostimulating Interstitial Laser Thermotherapy (imILT)
干预措施: imILT (Device)
Standard chemotherapy treatment
This study arm recieves chemotherapy treatment as standard care at the clinical study site.
干预措施: Standard chemotherapy treatment (Drug)
结局指标
主要结局
Treatment effect by radiology
时间窗: 12 months
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
次要结局
- Safety assessed by the incidence the of adverse events(12 months)
- Usability (user evaluation of instrument)(12 months)