NCT03694080

Calcium Electroporation for Early Colorectal Cancer

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

Summary

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.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Calcium electroporation	Patients with potentially curable colorectal rectal cancer will be treated preoperatively

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-05-01
• Completion: 2020-09-01
• First posted: 2018-10-03
• Last updated: 2019-07-05

Locations

1 site across 1 country: Denmark