Clinical trial · Interventional
Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours
NCT04225767CI-TRIAL-00062665CaEP-RunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Phase II Investigation of Calcium Electroporation as a Treatment for Cutaneous and Subcutaneous Malignant Tumours.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Calcium electroporation | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Calcium electroporation treatment
- description
- Experimental treatment with calcium electroporation for malignant cutaneous and subcutaneous tumours
- interventionNames
- Combination Product: Calcium electroporation
Primary outcomes (1)
- measure
- Tumour response (size)
- timeFrame
- 2 months
- description
- Response rate will be defined as number of responding lesions (partial or complete response) relative to treated lesions evaluated by changes in size (mm) by clinical examination with caliper measurement. Tumor response will be further documented using clinical photography.
Secondary outcomes (11)
- measure
- Treatment response up to 12 months (size)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Trial subject ≥ 18 years. * Trial subject must be able to understand the participant information. * Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. * The patient must have been offered other relevant standard treatment for their cancer disease. * The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.) if progressive or stable disease is present after a treatment period of two months or more. * The patient can undergo radiation therapy, provided that the treatment field does not involve treated area. * Performance status ECOG/WHO ≤2. * At least one cutaneous or subcutaneous tumour measuring up to 3 cm. * Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch). * Signed informed consent. Exclusion Criteria: • Pregnancy or lactation
References
Publications (1)
- DERIVEDVissing M, Ploen J, Pervan M, Vestergaard K, Schnefeldt M, Frandsen SK, Rafaelsen SR, Lindhardt CL, Jensen LH, Rody A, Gehl J. Study protocol designed to investigate tumour response to calcium electroporation in cancers affecting the skin: a non-randomised phase II clinical trial. BMJ Open. 2021 Jun 16;11(6):e046779. doi: 10.1136/bmjopen-2020-046779. PMID 34135049