Endoscopic Assisted Calcium Electroporation in Esophageal Cancer

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Patrick Achiam
• Treatments: Calcium

Criteria

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.