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.
This is a randomized controlled trial investigating efficacy of electrochemotherapy for early colorectal cancer