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Recruiting NCT05751733

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

No phase Interventional Gastrointestinal Stromal Tumors

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Apatinib Mesylate, Sunitinib, Imatinib dosage, Dasatinib, Reveratinib.
Who it may be relevant to
Registry conditions: Gastrointestinal Stromal Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Apatinib Mesylate
    Apatinib Mesylate (Etan) is a new type of small molecule anti-angiogenic agent, which is a small molecule TKI against VEGFR2 independently developed in China and has the effect of anti-C-Kit and PDGFR.
  • Drug Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
    Second-line TKI drugs

Primary outcome measures

  • Progression-Free survival (PFS) [Time frame: 12 months]
Secondary outcome measures (3)
  • Overall Survival (OS) [Time frame: 24 months]
  • Objective Response Rate (ORR) [Time frame: 24 months]
  • Disease Control Rate (DCR) [Time frame: 24 months]

Eligibility criteria

Inclusion 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);
  • Subjects 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.

Exclusion criteria

  • 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 small amount of ascites or pleural effusion without clinical symptoms;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Xiangya Hospital, Central South University — Changsha

Identifiers

NCT: NCT05751733 · XYGIST202202

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗