Neoplasms PancreaticNCT03187587
Percutaneous Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer
A study testing imILT and Standard chemotherapy treatment in people with Neoplasms Pancreatic, run by Clinical Laserthermia Systems AB at 1 site in Portugal.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neoplasms Pancreatic
- What is being tested?
- imILT and Standard chemotherapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 sitePortugal
- Study dates
- 17 May 2017to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 18Show fewer
- 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%)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma
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.
- Conditions
- Neoplasms Pancreatic
- Being tested
- imILT, Standard chemotherapy treatment
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Medical subject headings
- Pancreatic Neoplasms, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imILTDevice
Also called TRANBERG Thermal Therapy System
The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.
Standard chemotherapy treatmentDrug
The standard chemotherapy treamtment arm recieves only chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| imILT treatment | Experimental | Immunostimulating Interstitial Laser Thermotherapy (imILT) Receives: Device: imILT |
| Standard chemotherapy treatment | Active comparator | This study arm recieves chemotherapy treatment as standard care at the clinical study site. Receives: Drug: Standard chemotherapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect by radiology
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
Measured: 12 months
Secondary outcomes (2)
Safety assessed by the incidence the of adverse events
Evaluation of adverse events and laboratory analyses.
Measured: 12 months
Usability (user evaluation of instrument)
Analysis of instrument and user questionnaires relating to the ease of use.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start17 May 2017
- Primary completion25 Nov 2019
- Study completion1 Mar 2020
Why it stopped: Study was stopped in agreement with investigator due to slow recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms PancreaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Laserthermia Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Belarmino Goncalves, MD, Principal investigator, Portuguese Oncology Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03187587
- Sponsor's protocol ID
- CTP-2015-006
- Status last verified
- Jul 2021
- First submitted
- 13 Jun 2017
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Comparative Trial to Evaluate the Effect of imILT in Patients With Advanced Disease or Stage IV Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT03187587
- Acronym / sponsor ID
- CTP-2015-006
- Conditions
- Neoplasms Pancreatic
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped in agreement with investigator due to slow recruitment.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Clinical Laserthermia Systems ABIndustry (pharma, biotech, devices)
- Study start
- 17 May 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| imILT treatment | Experimental | Device: imILTImmunostimulating Interstitial Laser Thermotherapy (imILT) |
| Standard chemotherapy treatment | Active comparator | Drug: Standard chemotherapy treatmentThis study arm recieves chemotherapy treatment as standard care at the clinical study site. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imILTAlso: TRANBERG Thermal Therapy SystemThe imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy. | Device | imILT treatment |
| Standard chemotherapy treatmentThe standard chemotherapy treamtment arm recieves only chemotherapy. | Drug | Standard chemotherapy treatment |
Primary outcome
Treatment effect by radiology
Time frame: 12 months
Evaluation by Response Evaluation Criteria in Solid Tumours (RECIST)
2 secondary outcomes
Safety assessed by the incidence the of adverse events
Time frame: 12 months
Usability (user evaluation of instrument)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study was stopped in agreement with investigator due to slow recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belarmino Goncalves, MD principal investigator
Portuguese Oncology Institute of Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imILT and Standard chemotherapy treatment in people with Neoplasms Pancreatic, run by Clinical Laserthermia Systems AB at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was stopped in agreement with investigator due to slow recruitment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effect by radiology (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.