Calcium Electroporation for Non‑muscle‑invasive Bladder Cancer: First‑in‑Human Feasibility, Safety, and Early Efficacy Trial (CALCIFER)

Primary objective: evaluate the feasibility and safety of calcium electroporation for treatment of bladder cancer, establishing whether the procedure can be performed reliably and without unacceptable adverse events in this patient population.

Secondary objective: assess early tumor response after the intervention, providing preliminary data on antitumor activity that may guide further therapeutic development.

The trial enrolled patients diagnosed with bladder cancer or related urothelial malignancies, including both male and female individuals. The sponsor did not provide the total number of participants. Age eligibility was indicated by codes “3” and “4,” although specific age limits were not disclosed. All enrolled subjects were classified as patients, and no additional information regarding lifestyle factors, such as diet or physical activity, or detailed inclusion and exclusion criteria was supplied.

The CALCIFER trial is a Phase 3, randomized, double‑blind, controlled study evaluating the feasibility, safety, and early response of Calcium electroporation in patients with bladder cancer. Recruitment is planned from 31 May 2026 to 30 April 2029, with each participant involved for approximately 12 months, encompassing a screening visit, baseline assessment, treatment administration, scheduled follow‑up visits at weeks 4, 12, 24, and 48, and a final end‑of‑study visit at month 12. The screening visit confirms eligibility criteria and obtains baseline data; subsequent visits monitor adverse events, tumor response, and laboratory parameters. Early termination may occur if a participant experiences a serious adverse event related to the investigational procedure, exhibits disease progression requiring alternative therapy, withdraws consent, or fails to comply with protocol‑required assessments.