Calcium electroporation – a possible new treatment for esophageal cancer

Phase 1

• Conditions: Esophageal cancer; MedDRA version: 21.0Level: LLTClassification code 10015362Term: Esophageal cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-005787-58-DK
• Lead Sponsor: Michael Patrick

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-10
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1.Male or female =18 years old.
2.Histological verified malignant tumor in the esophagus, including the GEJ.
3.Subjects must have been evaluated by an MDT and been considered unsuitable for potential curative treatment.
4.Locally progressive disease, and other standard oncological treatment have been considered.
5.Performance status ECOG/WHO < 2.
6.Expected survival > 3 months.
7.Platelets = 50 billion/l, International Normalized Ratio (INR) < 1,5 (medical correction is allowed, e.g. correction of a high INR using vitamin K).
8.Subjects must be willing and able to comply with the procedure such as agreed follow-up visits.
9.Women of childbearing potential (WOCBP) and male partners to WOCBP should use adequate contraception during the trial (pill, spiral, injection of prolonged progestin, sub dermal implantation, hormone-containing vaginal devices, transdermal patches, condom).
10.Subjects must give written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1.Coagulation disorder that cannot be corrected.
2.Subjects with a clinically significant cardiac arrhythmia.
3.Pregnancy or lactation.
4.Concurrent treatment with another investigational medicinal product.
5.Stenosis that prevents passage of the endoscope with the device attached.
6.Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 Objective: Evaluate treatment response. <br>;Primary end point(s): Safety of CaEP for esophageal cancer, measured by registering Adverse Events (AE) and Serious Adverse Events (SAE). ;Timepoint(s) of evaluation of this end point: At follow up visits within 14 days after the given treatment.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At follow up visits within 2 months after the given treatment. ;Secondary end point(s): Secondary outcomes include: <br>- dysphagia (Mellow Pinkas dysphagia score) <br>- pain (Numeric Rating Scale, NRS)<br>- quality of life (QoL) (EORTC QLQ-C30)<br>- tumor response evaluated from computed tomography (CT) and upper endoscopy <br>- immunologic response