Calcium Electroporation for the Treatment of Colorectal Cancer

February 24, 2021 updated by: Zealand University Hospital
In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

Study Overview

Status

Completed

Detailed Description

A total of 6 evaluable patients with inoperable colorectal cancer are expected to be included in the study and the time for inclusion of patients is estimated to be 1-2 years. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.

All patients will be treated once, but in case of residual tumor tissue at follow-up, and if the investigator considers it safe, they will be offered re-treatment. A maximum of 3 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 12 months, starting from first treatment day.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Roskilde, Denmark, 4000
        • Zealand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically verified colorectal tumor
  • Conferred by multidisciplinary team (radiologists, surgeons and oncologists) discussing options possible for the patient, resulting in agreement that an endoscopic treatment with calcium electroporation should be offered to the patient.
  • Treatment free interval of minimum 2 weeks.
  • Thrombocytes ≥ 50 billions/l, INR >1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K.
  • Performance status ECOG/WHO ≤2
  • Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.)
  • Trial subject ≥ 18 years.
  • Trial subject must be able to understand the participants' information.
  • Signed informed consent. The patients are considered participants in the study after signing of the informed consent.

Exclusion criteria:

  • Coagulative disturbance that cannot be corrected
  • Pregnancy or lactation (Pregnancy is ruled out in fertile women by an HCG test in a blood sample)
  • Concurrent participation in other clinical trials that involve experimental drugs or participation in a clinical trial involving experimental drugs within 4 weeks prior to administration of the drug in this study.
  • Treatment with bevacizumab within the last 4 weeks.
  • Heavily inflamed colorectal mucus membrane with bleeding or ulcerations.
  • Implanted colon stent
  • Other clinical disease or previous treatments that make the investigator deem the patient unfit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium electroporation treatment
Experimental treatment with calcium electroporation for inoperabel colorectal cancer
Patients with inoperable colorectal cancer will be treated with calcium electroporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used)
Time Frame: 12 months
Safety will be assessed through registration of adverse events related to the treatment. Furthermore, CT scans and follow-up endoscopies are performed as a safety marker to exclude any perforations, bleeding or infections. CTCAE v4 will be used.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local response
Time Frame: 18 months
Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)
18 months
Systemic respons to calcium electroporation in colorectal cancer.
Time Frame: 12 months
Blood samples will be collected. Multiplex cytokine analyses and transcriptional analyses will be performed. Furthermore cell adhesion assay will be performed. Additionally circulating tumor DNA will be measured as a marker for the tumor burden
12 months
Tumorregression
Time Frame: 12 months
CT/MR scans are performed and analyzed according to RECIST-criteria
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Julie Gehl, DMSc, Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

May 31, 2018

Study Record Updates

Last Update Posted (Actual)

February 25, 2021

Last Update Submitted That Met QC Criteria

February 24, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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