Clinical trial · Interventional
Endoscopic Assisted Calcium Electroporation in Esophageal Cancer
Endoscopic Assisted Calcium Electroporation in Esophageal Cancer - a Safety Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium Gluconate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcium electroporation
- description
- Calcium gluconate 0.23 mmol/ml Maxium dosage 20 ml Intra tumoral injection
- interventionNames
- Drug: Calcium Gluconate
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 14 days after treatment
- description
- Registration of all AE/SAE´s within the first 14 days after treatment. The events will be assessed by CTCAE v4.0.
Secondary outcomes (4)
- measure
- Dysphagia
- timeFrame
- After 7 days, 2-4 weeks and after 6-8 weeks.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDEgeland C, Baeksgaard L, Gehl J, Gogenur I, Achiam MP. Palliative Treatment of Esophageal Cancer Using Calcium Electroporation. Cancers (Basel). 2022 Oct 27;14(21):5283. doi: 10.3390/cancers14215283. PMID 36358702