Back to resultsCalcium Electroporation for the Treatment of Colorectal Cancer
Primary Purpose
Colorectal Cancer Stage IV
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Calcium electroporation
Sponsored by
About this trial
This is an interventional device feasibility trial for Colorectal Cancer Stage IV
Eligibility Criteria
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.
Sites / Locations
- Zealand University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Calcium electroporation treatment
Arm Description
Experimental treatment with calcium electroporation for inoperabel colorectal cancer
Outcomes
Primary Outcome Measures
Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used)
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
Local response
Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)
Systemic respons to calcium electroporation in colorectal cancer.
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
Tumorregression
CT/MR scans are performed and analyzed according to RECIST-criteria
Full Information
NCT ID
NCT03542214
First Posted
January 29, 2018
Last Updated
February 24, 2021
Sponsor
Zealand University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03542214
Brief Title
Calcium Electroporation for the Treatment of Colorectal Cancer
Official Title
Calcium Electroporation for the Treatment of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
April 24, 2018 (Actual)
Primary Completion Date
October 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
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
In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Stage IV
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium electroporation treatment
Arm Type
Experimental
Arm Description
Experimental treatment with calcium electroporation for inoperabel colorectal cancer
Intervention Type
Combination Product
Intervention Name(s)
Calcium electroporation
Intervention Description
Patients with inoperable colorectal cancer will be treated with calcium electroporation
Primary Outcome Measure Information:
Title
Safety of the calcium electroporation procedure in colorectal cancer (registration of adverse events; CTCAE v4 will be used)
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Local response
Description
Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)
Time Frame
18 months
Title
Systemic respons to calcium electroporation in colorectal cancer.
Description
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
Time Frame
12 months
Title
Tumorregression
Description
CT/MR scans are performed and analyzed according to RECIST-criteria
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Gehl, DMSc
Organizational Affiliation
Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Calcium Electroporation for the Treatment of Colorectal Cancer
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