Gastrointestinal Stromal TumorsNCT05751733
Apatinib Mesylate Versus Standard Second-line TKI in the Treatment of Advanced GIST
A study testing Apatinib Mesylate and Sunitinib, Imatinib dosage, Dasatinib, Reveratinib in people with Gastrointestinal Stromal Tumors, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Apatinib Mesylate and Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital, Central South University
Changsha, Hunan, 410013
Gang Cheng, Ph.D, 15111489917, gangcheng0307@163.com
Heli Liu, Ph.D
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Apatinib Mesylate, Sunitinib, Imatinib dosage, Dasatinib, Reveratinib
- Keywords
- Gastrointestinal Stromal Tumors, Apatinib mesylate, tyrosine kinase inhibitors
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
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, ReveratinibDrug
Second-line TKI drugs
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Subjects received Apatinib mesylate Receives: Drug: Apatinib Mesylate |
| Control group | Active comparator | Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib. Receives: Drug: Sunitinib, Imatinib dosage, Dasatinib, Reveratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free survival (PFS)
Progression-free survival is the time from treatment to observed disease progression or death from any cause.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 24 months
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.
Measured: 24 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751733
- Sponsor's protocol ID
- XYGIST202202
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05751733
- Acronym / sponsor ID
- XYGIST202202
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- Gastrointestinal Stromal Tumors, Apatinib mesylate, tyrosine kinase inhibitors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 2 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Apatinib MesylateSubjects received Apatinib mesylate |
| Control group | Active comparator | Drug: Sunitinib, Imatinib dosage, Dasatinib, ReveratinibSubjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib MesylateApatinib 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 | Experimental group |
| Sunitinib, Imatinib dosage, Dasatinib, ReveratinibSecond-line TKI drugs | Drug | Control group |
Primary outcome
Progression-Free survival (PFS)
Time frame: 12 months
Progression-free survival is the time from treatment to observed disease progression or death from any cause.
3 secondary outcomes
Overall Survival (OS)
Time frame: 24 months
Objective Response Rate (ORR)
Time frame: 24 months
Disease Control Rate (DCR)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apatinib Mesylate and Sunitinib, Imatinib dosage, Dasatinib, Reveratinib in people with Gastrointestinal Stromal Tumors, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free survival (PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2023.