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| Name | Class |
|---|---|
| Suzhou Suncadia Biopharmaceuticals Co., Ltd. | INDUSTRY |
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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:
Patients with advanced GIST were randomly included in the trial group and the control group at a ratio of 1:1.
The objectives of this study were as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Subjects received Apatinib mesylate |
|
| Control group | Active Comparator | Subjects received TKI second-line therapy such as Sunitinib, Imatinib plus, Dasatinib, and Reveratinib. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free survival (PFS) | Progression-free survival is the time from treatment to observed disease progression or death from any cause. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C553458 | apatinib |
| D000077210 | Sunitinib |
| D000069439 | Dasatinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Sunitinib, Imatinib dosage, Dasatinib, Reveratinib | Drug | Second-line TKI drugs |
|
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. |
| 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. | 24 months |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011743 | Pyrimidines |