NCT05751733 Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
| NCT ID | NCT05751733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xiangya Hospital of Central South University |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 258 participants |
| Start Date | 2023-02-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 258 participants in total. It began in 2023-02-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT05751733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05751733 currently recruiting?
Yes, NCT05751733 is actively recruiting participants. Visit ClinicalTrials.gov or contact Xiangya Hospital of Central South University to inquire about joining.
Where is the NCT05751733 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05751733 clinical trial?
NCT05751733 is sponsored by Xiangya Hospital of Central South University. The trial plans to enroll 258 participants.