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Calcium Electroporation for Early Colorectal Cancer

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Calcium electroporation
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • Patients must be mentally capable of understanding the information given.

    • Patients must give written informed consent.
    • Histologically verified adenocarcinoma of the rectum or sigmoid colon.
    • Tumor described as passable at index endoscopy.
    • Men or women aged at least 18 years.
    • Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection.
    • ASA class I-II (Classification of the American Society of Anesthesiology)

Exclusion Criteria:

  • • Uncorrectable coagulation disorder.

    • Highly inflamed gastrointestinal tissue which is ulcerated and bleeding
    • Patients with ICD or pacemaker units.
    • Ongoing immunosuppressive treatment.
    • Patients with concomitant use of phenytoin.
    • Concurrent treatment with an investigational medicinal product.
    • Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments.
    • Advanced tumor stages, clinical UICC stage IV.
    • Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery
    • Acute surgical resection.
    • Pregnancy

Sites / Locations

  • Department of Surgery, Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Calcium Electroporation treatment

Arm Description

Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used

Secondary Outcome Measures

Histopathological characterization of the tumor
ypTNM staging and tumor regression grade according to current standards
Immunologic infiltration of the tumor tissue after calcium electroporation
Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
Immunoscore classification
Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.
Systemic immune response according to cytokine analysis
Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed
Systemic immune response according to flow cytometri
Blood samples will be collected prior to calcium electroporation and again at follow-up. Flow cytometri will be performed to evaluate immunological changes to the treatment.
Metastatic ability after potentially curable surgery
Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.
Cell proliferation as a marker for metastatic ability
Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability

Full Information

First Posted
September 25, 2018
Last Updated
July 3, 2019
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03694080
Brief Title
Calcium Electroporation for Early Colorectal Cancer
Official Title
Calcium Electroporation for Early Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery.
Detailed Description
This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer. In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment. Patients will be followed for one month after the elective surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Calcium Electroporation treatment
Arm Type
Experimental
Arm Description
Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.
Intervention Type
Combination Product
Intervention Name(s)
Calcium electroporation
Intervention Description
Patients with potentially curable colorectal rectal cancer will be treated preoperatively
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Description
Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Histopathological characterization of the tumor
Description
ypTNM staging and tumor regression grade according to current standards
Time Frame
14 days
Title
Immunologic infiltration of the tumor tissue after calcium electroporation
Description
Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
Time Frame
14 days
Title
Immunoscore classification
Description
Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.
Time Frame
14 days
Title
Systemic immune response according to cytokine analysis
Description
Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed
Time Frame
42 days
Title
Systemic immune response according to flow cytometri
Description
Blood samples will be collected prior to calcium electroporation and again at follow-up. Flow cytometri will be performed to evaluate immunological changes to the treatment.
Time Frame
42 days
Title
Metastatic ability after potentially curable surgery
Description
Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.
Time Frame
42 days
Title
Cell proliferation as a marker for metastatic ability
Description
Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability
Time Frame
42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Patients must be mentally capable of understanding the information given. Patients must give written informed consent. Histologically verified adenocarcinoma of the rectum or sigmoid colon. Tumor described as passable at index endoscopy. Men or women aged at least 18 years. Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection. ASA class I-II (Classification of the American Society of Anesthesiology) Exclusion Criteria: • Uncorrectable coagulation disorder. Highly inflamed gastrointestinal tissue which is ulcerated and bleeding Patients with ICD or pacemaker units. Ongoing immunosuppressive treatment. Patients with concomitant use of phenytoin. Concurrent treatment with an investigational medicinal product. Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. Advanced tumor stages, clinical UICC stage IV. Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery Acute surgical resection. Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Malene Broholm Andersen, MD
Phone
+45 41272742
Email
malea@regionsjaelland.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Ismail Gögenur, DMSc
Email
igo@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismail Gögenur, DMSc
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Malene Broholm, MD
Phone
+45 41272742
Email
malea@regionsjaelland.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Calcium Electroporation for Early Colorectal Cancer

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