A Study of SHR-1501 Combination With BCG Versus Placebo Combined With BCG in Subjects With Papillary-Only NMIBC

Официальное название

A Multicenter, Randomized, Double-blind Phase III Study of Intravesical SHR-1501 Combined With Bacillus Calmette Guerin (BCG) Versus Placebo Combined With BCG In Patients With High-risk BCG-naive Papillary-Only Non-muscle-invasive Bladder Cancer (NMIBC)

Обзор

This is a multicenter, randomized, Double-blind phase III study to determine the efficacy and safety of intravesical SHR-1501 combined with Bacillus Calmette Guerin (BCG) versus Placebo Combined with BCG in patients with high-risk BCG-naive Papillary-Only non-muscle-invasive bladder cancer (NMIBC)

Вмешательства

• Препарат SHR-1501+BCG
  SHR-1501+BCG
• Препарат Placebo +BCG
  Placebo +BCG

Первичные конечные точки

• Disease-Free Survival (DFS) assessed by BICR: Disease-free survival is defined as the time from randomization to date of DFS event assessed by BICR. [Срок оценки: Up to approximately 5 years]

Вторичные конечные точки (4)

• Disease-Free Survival (DFS) assessed by investigator: Disease-free survival is defined as the time from randomization to date of DFS event assessed by investigator. [Срок оценки: Up to approximately 5 years]
• Overall Survival (OS): Overall Survival defined as the time from randomization to the date of death from any cause. [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-riskpapillary-only non-muscle invasive bladder cancer (high-grade Ta and/or any T1, no carcinoma in situ);
• No previous BCG therapy;
• 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;
• 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 immunostimulant therapy or immune checkpoint inhibitors;
• Those who have previously received intravesical instillation of cytotoxic chemotherapy and have not experienced disease recurrence or progression before enrolment as assessed by investigator;
• Those who plan to undergo radical (partial) cystectomy during the study;
• 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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• The First Medical Center of the Chinese People's Liberation Army General Hospital — Пекин
• Sun Yat-sen University Cancer Center — Гуанчжоу

Идентификаторы

NCT: NCT07726992 · SHR-1501-302

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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