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

NCT05751733 | Recruiting

• 1 other identifier: XYGIST202202
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Stromal Tumors

Keywords

Gastrointestinal Stromal Tumors; Apatinib mesylate; tyrosine kinase inhibitors

Outcome Measures

Primary Outcomes (1)

• Progression-Free survival (PFS)

  Progression-free survival is the time from treatment to observed disease progression or death from any cause.

  12 months

Secondary Outcomes (3)

• Overall Survival (OS)

  24 months

• Objective Response Rate (ORR)

  24 months

• Disease Control Rate (DCR)

  24 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects received Apatinib mesylate

Drug: Apatinib Mesylate

Control group

ACTIVE COMPARATOR

Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib.

Drug: Sunitinib, Imatinib dosage, Dasatinib, Reveratinib

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.

Experimental group

Sunitinib, Imatinib dosage, Dasatinib, Reveratinib DRUG

Second-line TKI drugs

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead
• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

apatinib; Sunitinib; Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiazoles; Sulfur Compounds; Organic Chemicals; Pyrimidines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 2, 2023
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 2, 2023

Record last verified: 2023-02

Locations

CN (1)