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Идёт набор NCT07283835

Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

Фаза II С лечением Non Muscle Invasive Bladder Cancer High-grade Ta/ T1 Papillary Disease Bladder Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cretostimogene Grenadenorepvec, n-dodecyl-B-D-maltoside.
Кому может быть актуально
Состояния в реестре: Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

A Single-arm, Open-label, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Cretostimogene Grenadenorepvec in Patients With BCG-unresponsive High-risk Non-Muscle Invasive Bladder Cancer

Обзор

This study aims to evaluate the efficacy and safety of Cretostimogene in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without Ta/T1 papillary tumors.

Подробное описание

An open-label trial designed to evaluate Cretostimogene + DDM in patients with NMIBC who have failed prior BCG therapy. Single treatment arm that enrolled patients with carcinoma in situ with or without concomitant high-grade Ta or T1 papillary disease.

Вмешательства

  • Биопрепарат Cretostimogene Grenadenorepvec
    Engineered Oncolytic Adenovirus
  • Другое n-dodecyl-B-D-maltoside
    Transduction-enhancing agent

Первичные конечные точки

  • Complete response rate at any time in BCG-unresponsive high-risk NMIBC with or without Ta/T1 papillary tumors including CIS [Срок оценки: 36 months]
Вторичные конечные точки (6)
  • Duration of response (DOR) [Срок оценки: 36 months]
  • Assess high-grade reoccurrence free survival (RFS) [Срок оценки: 36 months]
  • Assess progression free survival (PFS) [Срок оценки: 36 months]
  • Complete response rate at 12, 24, and 36 months [Срок оценки: Assessed at 12, 24, and 36 months]
  • Overall survival rate at 36 months [Срок оценки: 36 months]
  • Safety: incidence and severity of adverse events (AE) and serious adverse events (SAE) [Срок оценки: 36 months]

Критерии участия

Критерии включения

In order to be eligible for participation in this trial, the patient must:

  • Be ≥18 years of age on day of signing informed consent.

\- Patients must have pathologically confirmed BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without concomitant Ta/T1 papillary disease.

  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  • Have all Ta and/or T1 disease resected and all CIS resected or fulgurated, as feasible, prior to study treatment.
  • Demonstrate adequate organ function.
  • Patients must be willing to comply with study mandated cystoscopies, urine cytology, urograms, biopsies, and other procedures (including TURBT or other resection for all Ta/T1 disease) for the duration of the study. Patients who withdraw consent for these procedures will be withdrawn from the trial.
  • Ineligible to receive radical cystectomy or refusal of radical cystectomy according to Investigator assessment.

Критерии исключения

  • Has current or past history of muscle invasive (T2 or higher stage) or locally advanced (T3/T4, any N) or metastatic bladder cancer.
  • History of urothelial carcinoma in the upper genitourinary tract (kidney, renal collecting system, ureter) or in the prostatic urethra, including urethral CIS, within 24 months prior to enrollment.
  • Has received systemic anti-cancer therapy, including investigational agents.
  • Has had prior systemic treatment (with the exception of checkpoint inhibitor therapy), radiation therapy, or surgery for bladder cancer other than TURBT or bladder biopsies.
  • Has any of the following within the 6 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, cerebrovascular accident, pulmonary embolus, uncontrolled hypertension, or uncontrolled congestive heart failure.
  • Cannot tolerate study-related biopsies, IVE administration, or 1-hour bladder hold of Cretostimogene.

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
Лечение

Центры проведения

Китай · 14 центров
  • Peking University First Hospital (First Clinical Medical School of Peking University) — Пекин
  • Chongqing University Cancer Hospital — Чунцин
  • Fujian Cancer Hospital — Фучжоу
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
  • Hunan Cancer Hospital — Чанша
  • The Affiliated Drum Tower Hospital of Nanjing University Medical School — Нанкин
  • The First Hospital of China Medical University — Шэньян
  • Qilu Hospital of Shandong University — Цзинань
  • … и ещё 6 центров

Идентификаторы

NCT: NCT07283835 · CG0070-II-CIS-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗