Comparing Apatinib Mesylate to Standard Treatments for Advanced GIST

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of Apatinib Mesylate compared to standard second-line tyrosine kinase inhibitors (TKIs) in patients with advanced gastrointestinal stromal tumors (GIST) who have experienced treatment failure with first-line TKIs. The study involves a randomized, open-label design where participants are assigned to either the Apatinib group or the control group receiving standard treatment. Additionally, the trial will investigate the expression levels of VEGFR2 in GIST and their correlation with tumor characteristics and recurrence risk. The goal is to provide high-level clinical evidence for treating late-stage GIST.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Previous molecular targeted therapy other than imatinib/Avatinib for the treatment of gastrointestinal stromal tumor;
2. Toxicity of previous imatinib/Avatinib treatment or other treatments has not recovered or reached NCICTCAE5.0≤ level 1;
3. 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;
4. 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;
5. Gastrointestinal stromal tumor with central nervous system metastasis;
6. Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption.

Where it's running

• Xiangya Hospital, Central South University
  Changsha, Hunan, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.