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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ 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.

Locations
Other Locations
China
Xiangya Hospital, Central South University
RECRUITING
Changsha
Time Frame
Start Date: 2023-02-01
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 258
Treatments
Experimental: Experimental group
Subjects received Apatinib mesylate
Active_comparator: Control group
Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib.
Related Therapeutic Areas
Sponsors
Leads: Xiangya Hospital of Central South University
Collaborators: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

This content was sourced from clinicaltrials.gov