Anlotinib + Benmelstobart vs Surgery for Patients With Localized Renal Cell Carcinoma Scheduled to Undergo Partial Nephrectomy

Официальное название

A Multicenter, Randomized Controlled Phase II Study of Neoadjuvant Anlotinib Hydrochloride Capsules Combined With Benmelstobart Injection Versus Surgery Alone for Localized Renal Cell Carcinoma Planned for Partial Nephrectomy

Обзор

Evaluation of long-term renal function improvement, surgical safety, as well as efficacy and safety of preoperative anlotinib hydrochloride capsules combined with benmelstobart injection versus surgery in patients with localized renal cell carcinoma undergoing partial nephrectomy

Вмешательства

• Препарат Anlotinib hydrochloride + Benmelstobart + Partial nephrectomy
  Patients receive neoadjuvant therapy with oral anlotinib hydrochloride capsules and intravenous benmelstobart injection, followed by partial nephrectomy for localized renal cell carcinoma.
• Процедура Partial nephrectomy
  Patients receive upfront partial nephrectomy without neoadjuvant therapy, as the standard treatment for localized renal cell carcinoma.

Первичные конечные точки

• Pentafecta Achievement [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (4)

• Primary tumor partial response (PR) rate in the experimental arm [Срок оценки: Through study completion, an average of 1 year]
• Safety [Срок оценки: Through study completion, an average of 2 years]
• 2-year DFS Rate [Срок оценки: 2-years]
• R.E.N.A.L. score changes in the experimental group [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• Aged between 18 and 75 years, inclusive.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Subjects with newly diagnosed cT1bN0M0 renal cell carcinoma (RCC) scheduled to undergo partial nephrectomy.
• Have at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• No prior systemic therapy for renal cell carcinoma, including but not limited to targeted therapy, immunotherapy, investigational therapy, or hormone therapy.

Критерии исключения

• Subjects with a solitary kidney tumor.
• Subjects with bilateral renal tumors or unilateral multiple renal tumors (n ≥ 2).
• Subjects with hereditary or familial renal tumors (e.g., von Hippel-Lindau \[VHL\] disease).
• Subjects with a prior history of renal transplantation.

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 · 14 центров

• Peking University Third Hospital — Пекин
• Jilin Provincial Cancer Hospital — Changchun
• Hunan Provincial Cancer Hospital — Чанша
• The First Affiliated Hospital, Zhejiang University School of Medicine — Ханчжоу
• Yunnan Provincial Cancer Hospital — Куньмин
• Nanjing Drum Tower Hospital — Нанкин
• The First Affiliated Hospital of Guangxi Medical University — Nanning
• The Affiliated Hospital of Qingdao University — Qingdao
• … и ещё 6 центров

Идентификаторы

NCT: NCT07627464 · ALTER-UC-011 · ALTER-UC-011

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗