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Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST | Clinical Trials | Clareo Health

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

NCT05751733•Xiangya Hospital of Central South University

View on ClinicalTrials.gov

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.

Detailed Description

The objectives of this study were as follows: 1. To explore the efficacy and safety of Apatinib compared with standard second-line treatment of advanced GIST with first-line TKI failure, and to provide high-level clinical evidence for the treatment of late-stage plasmatoma; 2. Explore the expression level and MVD value of VEGFR2 in GIST, and explore the relationship between the expression level and the location, size, mitotic image and recurrence risk grading of GIST.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Xiangya Hospital, Central South University

Changsha, Hunan, China

Key Dates

Start Date

February 1, 2023

Primary Completion Date

January 1, 2026

Completion Date

January 1, 2027

Last Updated

March 2, 2023

Enrollment

258

ESTIMATED participants

Conditions

Gastrointestinal Stromal Tumors

Interventions

Apatinib Mesylate

DRUG

Sunitinib, Imatinib dosage, Dasatinib, Reveratinib

DRUG

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

NCT06431451

Gastrointestinal Stromal Tumors

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RECRUITING

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

NCT05440357

Gastrointestinal Stromal Tumors

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RECRUITING

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

The Correlation Between Ripretinib Exposure and the Efficacy and Safety in Patients with Advanced GISTs

Second-line Pharmacotherapy Patterns and Outcomes of Advanced Gastrointestinal Stromal Tumor: A Real-world Study

A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

Clinical Research of Drug Holiday Based on MRD Detection in GIST Patients at High Risk of Recurrence

SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST

Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics