Electrochemotherapy for Effective Keratinocyte Cancer Cure (ELE-Cure)

Intervention Name: Electrochemotherapy (ECT) Intervention Description: Electrochemotherapy (ECT) is a minimally invasive treatment combining low-dose bleomycin chemotherapy with localised electric pulses to enhance drug uptake into tumour cells via electroporation. The intervention is delivered under local anaesthesia in an outpatient setting using the ePORE generator and CUTIS electrodes (Mirai Medical). Drug Details: International Non-proprietary Name (INN): Bleomycin Dose: 15,000 IU per treatment Duration: Single dose per treatment cycle; up to two cycles per lesion if partial response is observed at 8 weeks Mode of Administration: Intravenous or intratumoral injection, determined by lesion size and number, following ESOPE guidelines Device Details: Name: ePORE generator with CUTIS electrodes Manufacturer: Mirai Medical Ltd Mode of Administration: Subcutaneous probe delivering electric pulses to the lesion and a surrounding 5mm margin Treatment procedure: Participants enrolled in the trial's intervention arm will attend one treatment visit with their treating surgeon. Participants may have multiple lesions treated in a single treatment session. Your surgeon will perform the ECT in accordance with the updated European Standard Operating Procedures on Electrochemotherapy (ESOPE). Each treatment session is expected to last 60-120 minutes, depending on the number of lesions being treated. Each lesion treated will receive two pulses per electrode position, covering 100% of the visible lesion and a surrounding margin of 4-5mm (as marked pre-operatively). Coverage will be provided with overlapping fields in accordance with ESOPE guidelines, ensuring that the depth of electrode insertion is likely to be at least the depth of the tumour base. The route of bleomycin administration, intravenous (IV) vs intratumoral, is personalised based on lesion size and number, per ESOPE criteria. For the intratumoural route, electropration is delivered within 15 minutes of bleomycin and local anaesthetic injection. For the IV route, electroporation is delivered between 8 and 40 minutes after completion of the infusion. Each electroporation procedure requires no more than 5 minutes. You may receive multiple electroporation applications to treat a single lesion, depending on the lesion size. Lesions with partial response at 8 weeks may receive a second ECT cycle. Adherence and Fidelity: Adherence will be assessed by the treating surgeon and study nurse using a standardised procedure checklist. Fidelity will be maintained through training, use of ESOPE protocols, and documentation of treatment parameters in the case report form (CRF).