NCT02973217

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2019

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

2.6 years

First QC Date

November 22, 2016

Last Update Submit

December 16, 2020

Conditions

Neoplasms Pancreatic

Keywords

Hyperthermia, InducedLaser CoagulationLaser Therapy

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events)

    Evaluation of adverse events.

    36 months

Secondary Outcomes (4)

  • Inflammatory response in circulation measured by quantification of inflammatory cell populations

    36 months

  • Disease progression

    36 months

  • Evaluation of Quality of Life (using questionnaires)

    36 months

  • Usability of the device as evaluated by treatment logs

    36 months

Study Arms (1)

imILT

EXPERIMENTAL

Immunostimulating Interstitial Laser Thermotherapy (imILT)

Device: Immunostimulating Interstitial Laser Thermotherapy

Interventions

Immunostimulating Interstitial Laser ThermotherapyDEVICE
imILT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut J. Paoli et L. Calmettes (IPC)

Marseille, 13009, France

Location

Related Publications (1)

  • 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.

    PMID: 33278792DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsHyperthermia

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

October 1, 2016

Primary Completion

April 29, 2019

Study Completion

July 22, 2019

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)