NCT03542214

Calcium Electroporation for the Treatment of Colorectal Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

Detailed description

A total of 6 evaluable patients with inoperable colorectal cancer are expected to be included in the study and the time for inclusion of patients is estimated to be 1-2 years. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment. All patients will be treated once, but in case of residual tumor tissue at follow-up, and if the investigator considers it safe, they will be offered re-treatment. A maximum of 3 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 12 months, starting from first treatment day.

Conditions

• Colorectal Cancer Stage IV

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Calcium electroporation	Patients with inoperable colorectal cancer will be treated with calcium electroporation

Timeline

• Start date: 2018-04-24
• Primary completion: 2020-10-01
• Completion: 2021-01-01
• First posted: 2018-05-31
• Last updated: 2021-02-25

Locations

1 site across 1 country: Denmark