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

Recruiting now · Not applicable

Conditions studied: Gastrointestinal Stromal Tumors

In brief

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.

Key facts

Study ID

NCT05751733

Run by

Xiangya Hospital of Central South University

People needed

258

Starts

2023-02-01

Expected to finish

2027-01-01

Last updated by the study team

2023-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Xiangya Hospital, Central South University — Changsha, Hunan, China (enrolling)

Full record on ClinicalTrials.gov

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