Immunological Response After Ablative Therapy in the Liver | NCT03040453

Studies
Immunological Response After Ablative Therapy in the Liver

NCT03040453

Sponsor

Karolinska Institutet

Status

Withdrawn

Last Update Posted

Nov 30, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Hepatocellular Carcinoma
Immune Response

Interventions

Microwave ablation
Irreversible electroporation

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

poor recruitment

Expanded Access Info

Start Date

Jan 1, 2017Actual

Primary Completion Date

Jun 30, 2018Estimated

Completion Date

Sep 30, 2018Estimated

First Submitted Date

Jan 20, 2017

First Submission Date that Met QC Criteria

Feb 1, 2017

First Posted Date

Feb 2, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2020

Last Update Posted Date

Nov 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Local ablative treatment of Hepatocellular Carcinoma is performed primary on patients not eligible for liver transplant or liver resection. At our Hospital two different methods are used: Microwave ablation, where the tumor cells are heated up and killed, and Irreversible electroporation, where the tumor cells are exposed to an electrical field and nano-pores are formed in the cell membranes and the cells go into apoptosis (programed cell death).

Previous studies have shown effects on the immune system after ablative therapies.

The purpose of this study is to compare the immunological response after the wo different methods of killing the tumor cells.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Microwave ablation	Other	20 patients will be treated with microwave ablation	Device: Microwave ablation
Irreversible electroporation	Other	20 patients will be treated with irreversible electroporation	Device: Irreversible electroporation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Microwave ablation	Device		Microwave ablation
Irreversible electroporation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunological response	Change in immunological response	Change from baseline (morning of the procedure) measured at post operative day 1,7, 28 and 90

Secondary Outcomes

Measure	Description	Time Frame
Number of participants with complete radiological response at follow up 3, 6, 9 and 12 months.	Compare the effect of the two different ablative methods	Follow-up every three months for one year with CT scan.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hepatocellular carcinoma, maximum 3 lesions, maximum 30 mm in any cross section diameter
Physically fit to undergo general anaesthesia
Fully understand swedish instructions regarding the study

Exclusion Criteria:

Atrial fibrillation (for irreversible electroporation)
Pacemaker (for irreversible electroporation)
>3 lesions
> 30 mm in any cross section diameter

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacob Freedman, MD, PhD	Karolinska Instituet	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Surgery and Urology, Danderyd Hospital		Stockholm		18288	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D018274	Electroporation

Ancestor Terms

ID	Term
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D008919	Investigative Techniques
D055664	Electrochemical Techniques

Browse Leaves

Not provided

Browse Branches

Not provided