- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03542214
Calcium Electroporation for the Treatment of Colorectal Cancer
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Roskilde, Denmark, 4000
- Zealand University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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Patients with inoperable colorectal cancer will be treated with calcium electroporation
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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
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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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local response
Time Frame: 18 months
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Tumor biopsies will be analyzed regarding standard histology and immunologic infiltration (CD8/CD3 and PD-L1/PD1)
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18 months
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Systemic respons to calcium electroporation in colorectal cancer.
Time Frame: 12 months
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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
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12 months
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Tumorregression
Time Frame: 12 months
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CT/MR scans are performed and analyzed according to RECIST-criteria
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12 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julie Gehl, DMSc, Zealand University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Physiological Effects of Drugs
- Calcium-Regulating Hormones and Agents
- Calcium
Other Study ID Numbers
- HGH-2017-026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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