Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer

Neoplasms Pancreatic Clinical Trial

Official title:

An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03187587
• Other study ID #: CTP-2015-006
• Status: Terminated
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: March 1, 2020

Study information

• Verified date: July 2021
• Source: Clinical Laserthermia Systems AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 1, 2020
• Est. primary completion date: November 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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:

1. Hemoglobin =9 g/dL

2. Platelet count =75 x 109/L

3. International normalized ratio (INR) =1.7

4. WBC count =2 x 109/L

5. Absolute neutrophil count (ANC) =1 x 109/L

6. Albumin =2.8 g/dL, total bilirubin =3.0 mg/dL (51.3 µmol/L); ALT, AST =5 times upper limit of normal (ULN)

7. Serum chemistries sodium, potassium, and calcium within normal limits (WNL)

8. 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%)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neoplasms Pancreatic

Intervention

Device:
• imILT
The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.

Drug:
• Standard chemotherapy treatment
The standard chemotherapy treamtment arm recieves only chemotherapy.

Locations

Country	Name	City	State
Portugal	Portuguese Oncology Institute of Porto	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Laserthermia Systems AB

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment effect by radiology	Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)	12 months
Secondary	Safety assessed by the incidence the of adverse events	Evaluation of adverse events and laboratory analyses.	12 months
Secondary	Usability (user evaluation of instrument)	Analysis of instrument and user questionnaires relating to the ease of use.	12 months