HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer

Официальное название

A Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intravesical Chemotherapy After Transurethral Resection of Bladder Tumors in Patients With Non-Muscle-Invasive Bladder Cancer

Обзор

The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).

Подробное описание

In this study, patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) and planed to undergo Transurethral Resection of Bladder Tumors (TURBT) are randomized into HIVEC group and control group. In HIVEC group, HIVEC is performed with Gemcitabine Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes within 4 weeks, once a week (±5 days) for 6 to 8 times, once a month to 1 year. For the patients in the control group, Intravesical Chemotherapy is administered after TURBT. The primary endpoint is 2-year recurrence rate. Secondary end points include 1-year recurrence rate, recurrence-free survival (RFS) rate, disease free survival (DFS) rate, time to treatment failure (TTF), Success rate of therapeutic operation, Instrument performance evaluation, quality of international prostate symptom score, quality of Urinary Symptoms Distress Score. All efficacy analyses are conducted in the intention-to-treat population. Safety analysis include only patients who receive their randomly assigned treatment.

Вмешательства

• Процедура TURBT
  Transurethral Resection of Bladder Tumors
• Процедура HIVEC
  Hyperthermic Intravesical Chemotherapy with Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes. Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.
• Процедура Intravesical Chemotherapy
  Intravesical Chemotherapy with Gemcitabine (3g/150ml NS). Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.
• Препарат Gemcitabine
  Gemcitabine (3g/150ml NS).

Первичные конечные точки

• Recurrence rate [Срок оценки: 2-year]

Вторичные конечные точки (6)

• 1-year recurrence rate [Срок оценки: 1-year]
• Recurrence-free survival (RFS) rate [Срок оценки: 2-year]
• Time to treatment failure [Срок оценки: 2-year]
• Success rate of therapeutic operation [Срок оценки: 2-year]
• Quality of international prostate symptom score [Срок оценки: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.]
• Quality of bother of score [Срок оценки: Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment]

Критерии участия

Критерии включения

• Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time).
• Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors).
• KPS score ≥80, expected survival > 30 months.
• Pathological suggested non-myoinvasive urothelial carcinoma of the bladder.
• Age between 18 and 70 years, all genders.
• Volunteer to participate in this clinical trial and written informed consent.

Критерии исключения

• Patients with bladder cancer in situ.
• Combined with proven upper urinary tract or urethral tumors.
• The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4.
• Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy.
• Patients who had undergone partial cystectomy or abnormal bladder structure were judged by the investigator to be unsuitable for perfusion therapy.
• Patients with severe coagulation dysfunction.
• A history of allergy to injected drugs (gemcitabine).
• History of pelvic radiation, systemic chemotherapy, or immunotherapy.
• Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and other serious diseases.
• Patients with mental illness, substance abuse, alcoholism, and inability to cooperate.
• Breastfeeding, pregnant, or planning to have a baby in the near future.
• Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy.
• Participated in other clinical trials 1 month before the trial.
• Vesicoureteral regurgitation.
• The investigator considered it inappropriate to participate in this clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06327932 · HIVEC(PRG)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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