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

Not Applicable

Recruiting

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Apatinib Mesylate; Drug: Sunitinib, Imatinib dosage, Dasatinib, Reveratinib

• Registration Number: NCT05751733
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

Study Timeline

• Status Verified: 2023-02
• Study Start: 2023-02-01
• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-03-01
• Last Update Submitted: 2023-03-01
• Study First Posted: 2023-03-02
• Last Update Posted: 2023-03-02
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 258

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Apatinib Mesylate	Subjects received Apatinib mesylate
Control group	Sunitinib, Imatinib dosage, Dasatinib, Reveratinib	Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib.

Primary Outcome Measures

Name	Time	Method
Progression-Free survival (PFS)	12 months	Progression-free survival is the time from treatment to observed disease progression or death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	24 months	Overall Survival is the time from randomization to death from any cause.For subjects who had been lost to follow-up prior to death, the last follow-up time was usually calculated as the time of death.
Objective Response Rate (ORR)	24 months	Objective response rate refers to the proportion of patients whose tumor volume has decreased to a predetermined value and can maintain the minimum time limit, including complete response (CR) and partial response (PR) cases.
Disease Control Rate (DCR)	24 months	Disease control rate (DCR) refers to the proportion of patients whose tumors shrink or stabilize for a certain period of time, including complete response (CR), partial response (PR), and stable disease (SD) cases.

Trial Locations

Locations (1)

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China