Endoscopic Assisted Calcium Electroporation in Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958044
• Other study ID #: eCaEP2021
• Status: Completed
• Phase: Phase 1
• Start date: May 25, 2021
• Est. completion date: June 13, 2022

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

1. Male or female =18 years old.

2. Histological verified malignant tumor in the esophagus.

3. Subjects must have been considered unsuitable for potential curative treatment.

4. Locally progressive disease, and other standard oncological treatment have been administrated and/or considered first.

5. Performance status ECOG/WHO < 2.

6. Expected survival > 3 months.

7. Platelets = 50 billion/l, International Normalized Ratio (INR) < 1,5.

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.

10. Subjects must give written informed consent.

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• Calcium Gluconate
Calcium electroporation

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Michael Patrick Achiam

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Registration of all AE/SAE´s within the first 14 days after treatment. The events will be assessed by CTCAE v4.0.	14 days after treatment
Secondary	Dysphagia	According to Mellow Pinkas dysphgia scale	After 7 days, 2-4 weeks and after 6-8 weeks.
Secondary	Pain	Assesed by Numerical Rating Scale	After 7 days, 2-4 weeks and after 6-8 weeks.
Secondary	Qualitiy of life	Assesed by "EORTC QLQ-C30"	After 7 days, 2-4 weeks and after 6-8 weeks.
Secondary	90 days survival		90 days