NCT04958044

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Michael Patrick Achiam · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

In this pilot study, patients with non-curable esophageal cancer will be treated with endoscopic assisted calcium electroporation (CaEP). CaEP is a novel cancer treatment where intratumoral injection with calcium is combined with locally applied electrical pulses, in order to increase calcium influx which leads to tumor necrosis. It is hypothesized that: * Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer * CaEP debulks the tumor, facilitating the patient's ability to eat and drink In this single-arm pilot study, eight patients will be treated.

Detailed description

Electroporation facilitates the transport of molecules across the cell membrane and into the cell by means of electrical pulses. An electric field applied to the cell destabilizes the cell membrane forming cracks, which reseals after a few minutes. During this time slot, molecules which normally are impermeable to the cell membrane are able to cross into the cytosol of the cell. Within the last ten years, studies have shown that the combination of intratumoral injection of calcium and electroporation (Calcium electroporation/CaEP) is an effective method in killing cancer cells. CaEP has been evaluated in clinical studies in colorectal cancer, carcinomas in the head and neck area, and in cutaneous metastases with promising results. In this single-arm pilot study, eight patients with non-curable esophageal cancer will be included. It is hypothesized that: * Endoscopic assisted CaEP is a safe and feasible procedure in patients with non-curable esophageal cancer * CaEP debulks the tumor, facilitating the patient's ability to eat and drink * CaEP induces a systemic immunological response The primary objective is to evaluate the safety of CaEP for esophageal cancer. Adverse Events (AE) and Serious Adverse Events (SAE) will be evaluated. Secondary outcomes include: * dysphagia (Mellow Pinkas dysphagia score) * pain (Numeric Rating Scale, NRS) * quality of life (QoL) (EORTC QLQ-C30) * tumor response evaluated from computed tomography (CT) and upper endoscopy * immunologic response Tertiary outcomes include: ✓ 90-days survival Participants are initially treated once according to protocol. If well-tolerated, the treatment can be repeated.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Calcium Gluconate	Calcium electroporation

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-06-13
• Completion: 2022-06-13
• First posted: 2021-07-12
• Last updated: 2022-10-26

Locations

1 site across 1 country: Denmark