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Compares treatment options for Gastrointestinal Stromal Tumors
Official title Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
ClinicalTrials.gov ID: NCT05751733
What this study is testing
What is Apatinib Mesylate?
Apatinib Mesylate is an investigational medicine, being studied as a potential treatment for gastrointestinal stromal tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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);
- people 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;
You likely can't join 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...
- 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...
- Gastrointestinal stromal tumor with central nervous system metastasis;
- Inability to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting drug administration and absorption.
See the full eligibility criteria
- 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);
- people 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.