Actively Recruiting
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
Led by Xiangya Hospital of Central South University · Updated on 2023-03-02
258
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
Sponsors
X
Xiangya Hospital of Central South University
Lead Sponsor
S
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients voluntarily enrolled and signed informed consent with good compliance and follow-up
- Age 18 years or older at the time of signing informed consent
- Previous first-line TKI therapy (Imatinib or Avatinib) with treatment failure due to disease progression or toxicity intolerance
- Willingness to provide 10ml blood sample and fresh or archived tumor tissue for genetic testing if pre-C-Kit/PDGFRA test report is available
- ECOG performance status score of 0 to 1
- Predicted survival of at least 12 weeks
You will not qualify if you...
- Previous molecular targeted therapy other than Imatinib or Avatinib for GIST
- Unrecovered toxicity from prior Imatinib or Avatinib treatment or other therapies with severity above NCICTCAE5.0 level 1
- Presence of ascites or pleural effusion requiring drainage within 1 month before consent, except small asymptomatic amounts
- Diagnosis of a second primary cancer within the last 5 years except treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ
- Presence of central nervous system metastasis from GIST
- Inability to swallow or presence of chronic diarrhea or intestinal obstruction affecting drug administration or absorption
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410013
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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