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

NCT05751733 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2023-03-02

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    collaborator INDUSTRY

  • Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2026-01-01
Completion
2027-01-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05751733 on ClinicalTrials.gov