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

Sponsor
Xiangya Hospital of Central South University
Study ID
NCT05751733
Status
Recruiting
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Conditions

  • Gastrointestinal Stromal Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib Mesylate — DRUG
    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.
  • Sunitinib, Imatinib dosage, Dasatinib, Reveratinib — DRUG
    Second-line TKI drugs

Study Details

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.

Key Dates

Start date
Feb 1, 2023
Status verified
Feb 2023
Primary completion
Jan 1, 2026
Completion
Jan 1, 2027

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Subjects received Apatinib mesylate
  • Active Comparator: Control group
    Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib.

Primary Outcome Measure

Progression-Free survival (PFS) [ Time Frame: 12 months ]

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