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

Study Overview
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Brief Summary
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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.

Detailed Description
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The objectives of this study were as follows: 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; 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.

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

Conditions
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Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Drug: Apatinib Mesylate
* Drug: Sunitinib, Imatinib dosage, Dasatinib, Reveratinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Subjects received Apatinib mesylate | Drug: Apatinib Mesylate<br>* 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.<br>|
| Active Comparator: Control group<br>Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib. | Drug: Sunitinib, Imatinib dosage, Dasatinib, Reveratinib<br>* Second-line TKI drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free survival (PFS) | Progression-free survival is the time from treatment to observed disease progression or death from any cause. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | Overall Survival is the time from randomization to death from any cause.For subjects who had been lost to follow-up prior to death, the last follow-up time was usually calculated as the time of death. | 24 months | 
| Objective Response Rate (ORR) | Objective response rate refers to the proportion of patients whose tumor volume has decreased to a predetermined value and can maintain the minimum time limit, including complete response (CR) and partial response (PR) cases. | 24 months | 
| Disease Control Rate (DCR) | Disease control rate (DCR) refers to the proportion of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable disease (SD) cases. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Stromal Tumors, Apatinib mesylate, tyrosine kinase inhibitors