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 prior to intended curative surgery.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Patients with potentially curable colorectal rectal cancer will be treated preoperatively
Department of Surgery, Zealand University Hospital
Køge, Denmark
RECRUITINGIncidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used
Time frame: 42 days
Histopathological characterization of the tumor
ypTNM staging and tumor regression grade according to current standards
Time frame: 14 days
Immunologic infiltration of the tumor tissue after calcium electroporation
Specific immunohistochemical staining for PD-1/PD-L1, CD3 and CD8 will be performed on biopsies and the final surgical specimen.
Time frame: 14 days
Immunoscore classification
Tumor infiltration on T-cells and subtypes will be characterized according to the immunoscore classification system.
Time frame: 14 days
Systemic immune response according to cytokine analysis
Blood samples will be collected prior to calcium electroporation and again at follow-up. Multiplex cytokine analysis will be performed
Time frame: 42 days
Systemic immune response according to flow cytometri
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.
Time frame: 42 days
Metastatic ability after potentially curable surgery
Cell adhesion assay will be performed on blood samples to evalutate the metastatic ability.
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Time frame: 42 days
Cell proliferation as a marker for metastatic ability
Cell proliferation analyses will be performed on blood samples to evaluate metastatic ability
Time frame: 42 days