Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST

Официальное название

Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced Gastrointestinal Stromal Tumors: a Randomized, Open, Controlled, Single-center Clinical Study

Обзор

The goal of this Mesylate apatinib versus standard second-line TKI in the treatment of advanced gastrointestinal stromal tumors: a randomized, open, controlled, single-center clinical study is to explore the efficacy and safety of Apatinib compared with second-line treatment in advanced GIST patients with first-line TKI failure. The main questions it aims to answer are: * To explore the efficacy and safety of Apatinib compared with standard second-line treatment for GIST with advanced first-line TKI failure. * To explore the expression level and MVD value of VEGFR2 in GIST, and to explore the relationship between the expression level and the location, size, mitotic image and recurrence risk grading of GIST. Patients with advanced GIST were randomly included in the trial group and the control group at a ratio of 1:1.

Подробное описание

The objectives of this study were as follows:

1. To explore the efficacy and safety of Apatinib compared with standard second-line treatment of advanced GIST with first-line TKI failure, and to provide high-level clinical evidence for the treatment of late-stage plasmatoma; 2. Explore the expression level and MVD value of VEGFR2 in GIST, and explore the relationship between the expression level and the location, size, mitotic image and recurrence risk grading of GIST.

Вмешательства

• Препарат Apatinib Mesylate
  Apatinib Mesylate (Etan) is a new type of small molecule anti-angiogenic agent, which is a small molecule TKI against VEGFR2 independently developed in China and has the effect of anti-C-Kit and PDGFR.
• Препарат Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
  Second-line TKI drugs

Первичные конечные точки

• Progression-Free survival (PFS) [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Overall Survival (OS) [Срок оценки: 24 months]
• Objective Response Rate (ORR) [Срок оценки: 24 months]
• Disease Control Rate (DCR) [Срок оценки: 24 months]

Критерии участия

Критерии включения

• Patients were enrolled voluntarily and signed a written informed consent with good compliance and follow-up;
• Age ≥18 years (calculated on the date of signing the informed consent) for both men and women;
• Previous first-line TKI (Imatinib/Avatinib) therapy and eventual treatment failure (disease progression or toxicity intolerance during treatment);
• Subjects who provide pre-C-Kit /PDGFRA test reporting can provide 10ml blood sample and fresh or archived tumor tissue for genetic testing.
• ECOG score: 0 \~ 1;
• Predicted survival ≥12 weeks.

Критерии исключения

• Previous molecular targeted therapy other than imatinib/Avatinib for the treatment of gastrointestinal stromal tumor;
• Toxicity of previous imatinib/Avatinib treatment or other treatments has not recovered or reached NCICTCAE5.0≤ level 1;
• Patients with clinical symptoms of ascites or pleural effusion who need puncture drainage or who have received thoracic and ascites drainage within 1 month before signing informed consent, except those who only show a small amount of ascites or pleural effusion without clinical symptoms;
• A second primary malignancy within the last 5 years, except for basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix that has been adequately treated;
• Gastrointestinal stromal tumor with central nervous system metastasis;
• Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption.

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 · 1 центр

• Xiangya Hospital, Central South University — Чанша

Идентификаторы

NCT: NCT05751733 · XYGIST202202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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