NCT04816045

Neoadjuvant Electrochemotherapy for Colorectal Cancer - a Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Electrochemotheraoy	Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin
PROCEDURE	Electroporation with saline (placebo)	Electroporation in the control group is performed endoscopically with saline

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-07-01
• Completion: 2023-12-01
• First posted: 2021-03-25
• Last updated: 2021-03-25