A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC

Официальное название

A Multicenter, Randomized, Open-label Phase III Clinical Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Investigator-selected Chemotherapy In Patients With BCG-unresponsive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC) (NiBladder 1)

Обзор

This is a multicenter, randomized, open-label phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus investigator-selected chemotherapy in patients with BCG-unresponsive papillary-only non-muscle-invasive bladder cancer (NMIBC).

Вмешательства

• Препарат SHR-1501 for Injection
  SHR-1501 for injection.
• Препарат BCG for Injection
  Bacillus calmette guerin (BCG) for injection.
• Препарат Epirubicin Hydrochloride for Injection
  Epirubicin hydrochloride for injection.
• Препарат Pirarubicin Hydrochloride for Injection
  Pirarubicin hydrochloride for injection.
• Препарат Gemcitabine Hydrochloride for Injection
  Gemcitabine hydrochloride for injection.
• Препарат Hydroxycamptothecin for Injection
  Hydroxycamptothecin for injection.
• Препарат Mitomycin for Injection
  Mitomycin for injection.

Первичные конечные точки

• Disease-Free Survival (DFS) assessed by Blinded Independent Central Review (BICR) [Срок оценки: Up to approximately 5 years.]

Вторичные конечные точки (4)

• Disease-Free Survival (DFS) assessed by investigator [Срок оценки: Up to approximately 5 years.]
• Overall Survival (OS) [Срок оценки: Up to approximately 5 years.]
• Number of adverse events (AEs) as assessed by CTCAE v6.0. [Срок оценки: Up to approximately 5 years.]
• Number of serious adverse events (SAEs) as assessed by CTCAE v6.0. [Срок оценки: Up to approximately 5 years.]

Критерии участия

Критерии включения

• Aged at least 18 years, gender is not limited;
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;
• Histologic confirmation of high-risk non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ); BCG-unresponsive;
• Cystoscopy within 6 weeks before the randomization shows that the lesion has been completely removed; for T1 stage lesions, pathological results must show the presence of bladder muscle tissue;
• Not suitable for or unwilling to undergo radical cystectomy;
• Sufficient hematology and organ function.

Критерии исключения

• Previous histopathological diagnosis was muscle-invasive, locally advanced or metastatic urothelial carcinoma (T2 or T3 or T4 or N+ or M+);
• Received surgery such as TURBT or radiotherapy for bladder lesions within 2 weeks before the randomization; Major surgery was performed within 28 days before randomization;
• Those who have previously received the following treatments and have not experienced disease recurrence or progression before enrolment: a) Intravesical infusion of cytotoxic chemotherapy or other drugs (such as oncolytic viruses), etc; b) Immune checkpoint inhibitors; c) Other investigatory drugs for the treatment of NMIBC;
• Those who have previously received immunostimulant therapy;
• Upper urinary tract tumor detected by CTU or MRU during screening period, urethral prostate tumor detected by cystoscopy, or other concomitant malignant tumors within 5 years before the first administration;
• Previous medical history or examination suggests active tuberculosis within 1 year prior to the randomization.

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

Лечение

Центры проведения

Китай · 2 центра

• Peking University First Hospital — Пекин
• Renji Hospital Affiliated to Shanghai Jiao Tong University School — Шанхай

Идентификаторы

NCT: NCT07424287 · SHR-1501-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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