NCT07555769尚未招募1 期
Calcium Electroporation for Urinary Bladder Tumors: A First-in-human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial
Juan Luis Vásquez0 个研究点目标入组 20 人开始时间: 2026年6月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Safety within 3 months post-treatment assessed by adverse and serious adverse events.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Correction is allowed
排除标准
- •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)
研究组 & 干预措施
Intervention arm with participants treated with calcium electroporation
Experimental
Intervention arm with participants treated with calcium electroporation
干预措施: Calcium electroporation (Procedure)
Intervention arm with participants treated with calcium electroporation
Experimental
Intervention arm with participants treated with calcium electroporation
干预措施: Intratumoral calcium injection (Drug)
Intervention arm with participants treated with calcium electroporation
Experimental
Intervention arm with participants treated with calcium electroporation
干预措施: Transurethral electroporation (Device)
结局指标
主要结局
Safety within 3 months post-treatment assessed by adverse and serious adverse events.
时间窗: From treatment to follow-up after 3 months
Safety within 3 months post-treatment assessed by adverse and serious adverse events (CTCAE ver. 6.0).
次要结局
- Safety within 12 months post-treatment assessed by adverse and serious adverse events.(From treatment to 12 months follow-up)
- Response rate of tumor(From treatment to 12 months follow-up)
- Local control of tumor(From treatment to 12 months follow-up)
- Tumor response to CaEP(From treatment to 12 months follow-up)
- Dissemination of tumor to other sites of the bladder(From treatment to 12 months follow-up)
- Metastasis of tumor to other sites in the body will be evaluated by CT scan(From treatment to 12 months follow-up)
- Time to progression evaluated by the revised RECIST criteria on CT scan(From treatment to 12 months follow-up)
- Progression-free survival rate evaluated by cystoscopy, biopsy and CT scan(From treatment to 12 months follow-up)
- Evaluation of quality of life using EORTC-QLQ-C30 before treatment and at follow-up(From treatment to 12 months follow-up)
- Evaluation of urinary symptoms registered in the ICIQ-FLUTS/ICIQ-MLUTS(From treatment to 12 months follow-up)
- Evaluation of sexual matters registered in the ICIQ-FLUTSsex/ICIQ-MLUTSsex(From treatment to 12 months follow-up)
- All-cause mortality and cancer related mortality within 12 months(From treatment to 12 months follow-up)
- Experiences and opinions of up to ten of the patients that participate in the qualitative interviews(From treatment to 3 months follow-up)
- Concentration of calcium in a blood sample before injection of calcium gluconate 30 minutes and 2 hours after injection(Before treatment (Baseline), 30 minutes after injection of calcium gluconate, and 2 hours after injection of calcium gluconate)
研究者
Juan Luis Vásquez
Assoc. Prof, Chief Consultant, MD, PhD
Zealand University Hospital
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