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Calcium Electroporation for the Treatment of Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03542214
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : February 25, 2021
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:
In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Stage IV Combination Product: Calcium electroporation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Calcium Electroporation for the Treatment of Colorectal Cancer
Actual Study Start Date : April 24, 2018
Actual Primary Completion Date : October 1, 2020
Actual Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Experimental: Calcium electroporation treatment
Experimental treatment with calcium electroporation for inoperabel colorectal cancer
Combination Product: Calcium electroporation
Patients with inoperable colorectal cancer will be treated with calcium electroporation

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Local response [ Time Frame: 18 months ]
    Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)

  2. 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

  3. Tumorregression [ Time Frame: 12 months ]
    CT/MR scans are performed and analyzed according to RECIST-criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03542214

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Zealand University Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Zealand University Hospital
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Principal Investigator: Julie Gehl, DMSc Zealand University Hospital
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Responsible Party: Zealand University Hospital Identifier: NCT03542214    
Other Study ID Numbers: HGH-2017-026
First Posted: May 31, 2018    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs