Neoplasms PancreaticNCT02973217
Immunostimulating Interstitial Laser Thermotherapy in Pancreatic Cancer
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Neoplasms Pancreatic, run by Clinical Laserthermia Systems AB at 1 site in France.
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?
- Immunostimulating Interstitial Laser Thermotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to 22 Jul 2019
- 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
- Cytohistological diagnosis of ductal pancreatic adenocarcinoma .
- Stage III disease (see above).
- The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due to lack of demonstrable efficiency or to the side effects of the drugs.
- Age between 18 and 80 years.
- Anticipated compliance with treatment and follow-up.
- Double informed consent for both imILT and possible surgery with radical intent (in the event of pre-operative overstaging).
- At least a part of the tumor can be treated with imILT without damage to surrounding vital structures.
- Have an ECOG performance status < 1 (l'Eastern Cooperative Oncology Group)
Who cannot join
- Not a candidate for laparotomy.
- Becoming resectable after neoadjuvant chemotherapy.
- Other simultaneous treatments for the same neoplasm.
- Simultaneous other malignancies except for basal cell carcinoma.
- HIV positive.
- Active autoimmune disease.
- Systemic corticosteroid medication.
- Pregnancy or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III 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 in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.
This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.
- Conditions
- Neoplasms Pancreatic
- Being tested
- Immunostimulating Interstitial Laser Thermotherapy
- 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.
Immunostimulating Interstitial Laser ThermotherapyDevice
| Study group | Role | What they receive |
|---|---|---|
| imILT | Experimental | Immunostimulating Interstitial Laser Thermotherapy (imILT) Receives: Device: Immunostimulating Interstitial Laser Thermotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events)
Evaluation of adverse events.
Measured: 36 months
Secondary outcomes (4)
Inflammatory response in circulation measured by quantification of inflammatory cell populations
Quantification of cellular infiltrate and activation markers by flow cytometry.
Measured: 36 months
Disease progression
Analysis of the percentage of patients with no new oncological events.
Measured: 36 months
Evaluation of Quality of Life (using questionnaires)
Evaluation of Quality of Life is evaluated using standardized questionnaires.
Measured: 36 months
Usability of the device as evaluated by treatment logs
Evaluation of the laser system by analysis of treatment logs of the device.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion29 Apr 2019
- Study completion22 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Laserthermia Systems AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973217
- Sponsor's protocol ID
- CTP-2015-008
- Status last verified
- Dec 2020
- First submitted
- 22 Nov 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2.
PubMed 33278792
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open, Non Comparative Trial to Evaluate Safety and Feasibility of Immunostimulating Interstitial Laser Thermotherapy (imILT) in Stage III Pancreatic Carcinoma
- ClinicalTrials.gov ID
- NCT02973217
- Acronym / sponsor ID
- CTP-2015-008
- Conditions
- Neoplasms Pancreatic
- Keywords
- Hyperthermia, Induced, Laser Coagulation, Laser Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Clinical Laserthermia Systems ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- 29 Apr 2019 (actual)
- Study completion
- 22 Jul 2019 (actual)
- First posted
- 25 Nov 2016 (estimated)
- 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 in patients diagnosed with pancreatic cancer. The purpose is also to investigate the functionality and safety as well as understanding of the subsequent immunological effects.
This trial is prospective, open and non-randomized. Five patients diagnosed with pancreatic cancer will be treated in this trial, which is estimated to be carried out during a time period of 36 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| imILT | Experimental | Device: Immunostimulating Interstitial Laser ThermotherapyImmunostimulating Interstitial Laser Thermotherapy (imILT) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cytohistological diagnosis of ductal pancreatic adenocarcinoma .
- Stage III disease (see above).
- The patient is not a candidate for continued chemotherapy or (chemo)radiotherapy due to lack of demonstrable efficiency or to the side effects of the drugs.
- Age between 18 and 80 years.
- Anticipated compliance with treatment and follow-up.
Key exclusion criteria (8 listed)
- Not a candidate for laparotomy.
- Becoming resectable after neoadjuvant chemotherapy.
- Other simultaneous treatments for the same neoplasm.
- Simultaneous other malignancies except for basal cell carcinoma.
- HIV positive.
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 |
|---|---|---|
| Immunostimulating Interstitial Laser Thermotherapy | Device | imILT |
Primary outcome
Safety (adverse events)
Time frame: 36 months
Evaluation of adverse events.
4 secondary outcomes
Inflammatory response in circulation measured by quantification of inflammatory cell populations
Time frame: 36 months
Disease progression
Time frame: 36 months
Evaluation of Quality of Life (using questionnaires)
Time frame: 36 months
Usability of the device as evaluated by treatment logs
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 33278792Paiella S, Casetti L, Ewald J, Marchese U, D'Onofrio M, Garnier J, Landoni L, Gilabert M, Manzini G, Esposito A, Secchettin E, Malleo G, Lionetto G, De Pastena M, Bassi C, Delpero JR, Salvia R, Turrini O. Laser Treatment of Pancreatic Cancer with Immunostimulating Interstitial Laser Thermotherapy Protocol: Safety and Feasibility Results From Two Phase 2a Studies. J Surg Res. 2021 Mar;259:1-7. doi: 10.1016/j.jss.2020.10.027. Epub 2020 Dec 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immunostimulating Interstitial Laser Thermotherapy in people with Neoplasms Pancreatic, run by Clinical Laserthermia Systems AB at 1 site in France.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 17 Dec 2020. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety (adverse events) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02973217, which also lists 1 linked publication.
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 17 Dec 2020.