search
Back to results

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

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Apatinib Mesylate
Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors focused on measuring Gastrointestinal Stromal Tumors, Apatinib mesylate, tyrosine kinase inhibitors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya Hospital, Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Subjects received Apatinib mesylate

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)
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)
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)
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.

Full Information

First Posted
February 8, 2023
Last Updated
March 1, 2023
Sponsor
Xiangya Hospital of Central South University
Collaborators
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05751733
Brief Title
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
Collaborators
Suzhou Suncadia Biopharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors
Keywords
Gastrointestinal Stromal Tumors, Apatinib mesylate, tyrosine kinase inhibitors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Subjects received Apatinib mesylate
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib.
Intervention Type
Drug
Intervention Name(s)
Apatinib Mesylate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
Intervention Description
Second-line TKI drugs
Primary Outcome Measure Information:
Title
Progression-Free survival (PFS)
Description
Progression-free survival is the time from treatment to observed disease progression or death from any cause.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
24 months
Title
Objective Response Rate (ORR)
Description
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.
Time Frame
24 months
Title
Disease Control Rate (DCR)
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Cheng, Ph.D
Phone
15111489917
Email
gangcheng0307@163.com
First Name & Middle Initial & Last Name & Degree
Heli Liu, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs