Clinical trial · Interventional
Histopathologic Effect of Calcium Electroporation on Cancer in the Skin
Phase II Investigation of the Histopathologic Effect of Calcium Electroporation on Cancer in the Skin (CAEP-B)
NCT04259658CI-TRIAL-00070158CAEP-BcompletedPhase 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)
In this phase II study we investigate the effect of calcium electroporation on cancer in the skin investigated by histopathology.
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 cutaneous metastases.
- interventionNames
- Combination Product: Calcium electroporation
Primary outcomes (1)
- measure
- The effect of calcium electroporation on tumor infiltrating lymphocyte (TIL) population.
- timeFrame
- 2 days
- description
- The primary endpoint of this study is to evaluate differences in TIL population in tissue samples from treated cancer tumours two days after calcium electroporation treatment compared to before treatment (biopsy taken on the day of treatment before the calcium electroporation procedure). TIL content in biopsies will be evaluated by pathological examination and expressed as percent of cells.
Secondary outcomes (23)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Trial subject must be able to understand the participant information. * Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology. * The patient can undergo any simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy etc.). * The patient can undergo radiation therapy during the study period, provided that the treatment field does not involve the treated area. * Performance status ECOG/WHO ≤2 * At least one cutaneous or subcutaneous tumour measuring at least 5 mm. * 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 * Allergy to local anaesthesia
References
Publications (0)
Data not yet available
No reference posted for this study.