Comparing Apatinib Mesylate to Standard Treatments for Advanced GIST

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

This study is testing if a new drug called Apatinib Mesylate can work better than standard treatments for patients with advanced gastrointestinal stromal tumors who haven't had success with their first treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xiangya Hospital of Central South University (Academic / other)
• Drugs / interventions: Imatinib, Avatinib, apatinib
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05751733 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with advanced GIST who have failed first-line TKI therapy.

Not a fit: Patients who have previously received molecular targeted therapy other than imatinib or avatinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective treatment option for patients with advanced GIST who have not responded to first-line therapies.

How similar studies have performed: While the specific use of Apatinib in this context may be novel, other studies have shown promising results with similar approaches in treating advanced GIST.

Eligibility criteria

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 this trial is running

Changsha, Hunan

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

Conditions Gastrointestinal Stromal Tumors; Apatinib mesylate; tyrosine kinase inhibitors