Calcium Electroporation for Early Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT03694080|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Combination Product: Calcium electroporation||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Calcium Electroporation for Early Colorectal Cancer|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||September 1, 2020|
Experimental: Calcium Electroporation treatment
Calcium electroporation for colorectal cancer as a preoperative treatment before elective surgery.
Combination Product: Calcium electroporation
Patients with potentially curable colorectal rectal cancer will be treated preoperatively
- Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 42 days ]Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used
- Histopathological characterization of the tumor [ Time Frame: 14 days ]ypTNM staging and tumor regression grade according to current standards
- Immunologic infiltration of the tumor tissue after calcium electroporation [ Time Frame: 14 days ]Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
- Immunoscore classification [ Time Frame: 14 days ]Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.
- Systemic immune response according to cytokine analysis [ Time Frame: 42 days ]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 [ Time Frame: 42 days ]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 [ Time Frame: 42 days ]Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.
- Cell proliferation as a marker for metastatic ability [ Time Frame: 42 days ]Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability
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 ClinicalTrials.gov identifier (NCT number): NCT03694080
|Contact: Malene Broholm Andersen, MD||+45 firstname.lastname@example.org|
|Contact: Ismail Gögenur, DMScemail@example.com|
|Department of Surgery, Zealand University Hospital||Recruiting|
|Køge, Denmark, 4600|
|Contact: Malene Broholm, MD +45 41272742 firstname.lastname@example.org|
|Principal Investigator:||Ismail Gögenur, DMSc||Zealand University Hospital|