This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer
This is a phase 2 randomized controlled trial. The study is blinded. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with electrochemotherapy, compared with electroporation alone, 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 are treated with electrochemotherapy (bleomycin) and 12 patients with electroporation alone (placebo) 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
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin
Electroporation in the control group is performed endoscopically with saline
Tumor stage
Preoperative tumor stage will be compared with pathological assessment of the surgical specimen and comared between the two study arms using TNM stage
Time frame: 6 months
Gene expressional changes in the tumor microenvironment
Biopises are collected before the intervention and compared with the surgical specimen using NanoString technology. The PanCancer IO 360 gene panel will be used, a predefined panel of 770 genes.
Time frame: 6 months
Composition of fusobacterium
To characterize the spatial distribution and organization of bacteria in situ, some of the samples will be assessed microscopically. Confocal laser scanning microscopy will be performed on formalin-fixed, paraffin-embedded tissue of both diseased and normal tissue. This will allow us to investigate treatment affects the bacterial composition of fusobacterium.
Time frame: 6 months
PD-1/PD-L1
Immunohistochemical staining for PD-1/PD-L1
Time frame: 6 months
CD3
Immunohistochemical staining for CD3
Time frame: 6 months
CD8
Immunohistochemical staining for CD8
Time frame: 6 months
CD28
Immunohistochemical staining for CD28
Time frame: 6 months
VAR2
Immunohistochemical staining for VAR2
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Time frame: 6 months