Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery

Официальное название

The Efficacy of Vebreltinib Combined With Temozolomide for Glioblastoma (GBM) After Surgery: a Study Protocol for a Prospective, Open-label ,Multi-center, Randomized, Controlled Trial in China

Обзор

The purpose of this study is to explore the effects of Vebreltinib in primary glioblastoma patients receiving a combination therapy of chemotherapy (temozolomidel) and MET-TKI.

Вмешательства

• Препарат Vebreltinib + Temozolomide
  Vebreltinib is a capsule in the form of 25 mg and 100mg, twice daily. Participants received Vebreltinib (300 mg Bid) in combination with Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).
• Препарат Temozolomide
  Participants received Temozolomide (150 mg/ m2) treatment, every 4 weeks for up to 6 cycles (Induction).

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]

Вторичные конечные точки (4)

• Overall survival (OS) [Срок оценки: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
• The Karnof sky Performance status scale (KPS) [Срок оценки: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
• Objective response rate (ORR) [Срок оценки: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]
• Incidence of adverse events (AEs) [Срок оценки: Every 4 weeks (±14 days) from enrollment until the last enrolled participant completes a 12-month follow-up or is lost to follow-up.]

Критерии участия

Критерии включения

• Aged 18-65 years, female or male
• Newly diagnosed GBM (WHO grade 4) patients with maximal surgical resection
• c-MET overexpression diagnosed by IHC
• KPS ≥60
• Adequate hematological, renal, and hepatic function.

All patients should meet the following criteria:

• absolute neutrophil count (ANC) ≥1.5 × 109/L and platelet count≥100 × 109/L
• serum creatinine clearance ≥80 mL/min
• total bilirubin level ≤ 1.5 × ULN (except patients with Gilbert syndrome)
• aspartate aminotransferase (AST) ≤ 3.0 × ULN, alanine aminotransferase (ALT) ≤ 3.0 × ULN, and AST/ALT < 2.5 × ULN
• The patient and his/her family members were informed and provided signed and informed consent

Критерии исключения

• Any previous postoperative treatment except for concurrent chemoradiotherapy;
• Individuals unable to undergo cranial MRI examination;
• Active hemorrhage detected by cranial CT or MRI scan before enrollment;
• Uncontrolled hypertension;
• Decompensated heart failure, unstable angina pectoris, acute myocardial infarction, or persistent and clinically significant arrhythmias within 3 months before enrollment;
• Anti-HIV (+), or both anti-HCV and HCV-RNA (+), or HBsAg positive with HBV-DNA >1000IU/ml;
• Individuals requiring long-term continuous use of hematopoietic growth factors or platelet transfusions;
• Pregnant or lactating women;
• Individuals who have received other clinical trial drugs within 30 days before the first dose of the study drug;
• Individuals deemed unsuitable for participation in this clinical trial by the investigator.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06780592 · KY2024-754

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗