Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial

Официальное название

Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial

Обзор

This phase I study evaluates intravesical calcium electroporation (CaEP) with a new transurethral electrode. The study is primarily designed to assess the safety of CaEP and secondarily, to preliminary explore the efficacy in patients with limited alternative therapies. The anticipated benefits and structured safety precautions justify the ethical conduct of the investigation.

Вмешательства

• Процедура Calcium electroporation
  Calcium electroporation involves injection of calcium gluconate into the urinary bladder tumor followed by short, electric pulses (electroporation) with the transurethral electrode
• Препарат Intratumoral calcium injection
  Intratumoral injection of calcium gluconate in the urinary bladder
• Устройство Transurethral electroporation
  After injection of calcium into tumor, electroporation is applied using the transurethral electrode

Первичные конечные точки

• Safety within 3 months post-treatment assessed by adverse and serious adverse events. [Срок оценки: From treatment to follow-up after 3 months]

Вторичные конечные точки (12)

• Safety within 12 months post-treatment assessed by adverse and serious adverse events. [Срок оценки: From treatment to 12 months follow-up]
• Response rate of tumor [Срок оценки: From treatment to 12 months follow-up]
• Local control of tumor [Срок оценки: From treatment to 12 months follow-up]
• Tumor response to CaEP [Срок оценки: From treatment to 12 months follow-up]
• Dissemination of tumor to other sites of the bladder [Срок оценки: From treatment to 12 months follow-up]
• Metastasis of tumor to other sites in the body will be evaluated by CT scan [Срок оценки: From treatment to 12 months follow-up]
• Time to progression evaluated by the revised RECIST criteria on CT scan [Срок оценки: From treatment to 12 months follow-up]
• Progression-free survival rate evaluated by cystoscopy, biopsy and CT scan [Срок оценки: From treatment to 12 months follow-up]
• Evaluation of quality of life using EORTC-QLQ-C30 before treatment and at follow-up [Срок оценки: From treatment to 12 months follow-up]
• Evaluation of urinary symptoms registered in the ICIQ-FLUTS/ICIQ-MLUTS [Срок оценки: From treatment to 12 months follow-up]
• Evaluation of sexual matters registered in the ICIQ-FLUTSsex/ICIQ-MLUTSsex [Срок оценки: From treatment to 12 months follow-up]
• All-cause mortality and cancer related mortality within 12 months [Срок оценки: From treatment to 12 months follow-up]

Критерии участия

Критерии включения

• Age ≥ 18 years and able to understand participant information and give informed consent
• Histologically verified urothelial bladder tumor
• Unfit for cystectomy and/or radiotherapy
• Patients with recurrence after radiotherapy unfit for salvage cystectomy
• Disease where other treatments are considered unsuitable or have been declined by the patient
• The patient may receive simultaneous systemic treatment
• Selected high-burden non-muscle-invasive bladder tumors after MDT assessment
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2
• Life expectancy of ≥ 3 months
• Patients must be deemed able to tolerate general anesthesia
• Sexually active participants in the reproductive age must use contraception. Accepted contraception includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization
• Patients must stop treatment with anticoagulants before surgery in accordance with national guidelines
• Plasma ionized Ca2+ must be within the normal upper limit. Correction is allowed
• Hematology

• Thrombocytes ≥ 50 billion/L
• International normalized ratio (INR) ≤ 1.5. Correction is allowed

Критерии исключения

• Pregnancy (confirmed by a blood sample) or lactation
• Allergy to calcium gluconate or any of its excipients
• Any clinical condition or previous treatment, that in the investigators' opinion made the patient ineligible
• Contraindications to treatment with calcium gluconate as described:

• Hypersensitivity to calcium gluconate or any of its excipients
• Hypercalcemia (e.g. due to hyperparathyroidism, hypervitaminosis D, decalcifying malignancies, renal insufficiency, immobilization osteoporosis, sarcoidosis, milk-alkali syndrome)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07555769 · 2026-526388-39-00 · 2026-526388-39-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗