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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm for Apatinib | Experimental | 500 mg,p.o.,qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | 500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS(progress free survival) | PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause | From assignment of the first subject to 3 months later after the last participant is recruited |
| Measure | Description | Time Frame |
|---|---|---|
| OS(overall survival) | OS is defined as the time from date of assignment to death due to any cause | From assignment of the first subject until 30 death events observed, up to 2 years |
| ORR(objective response rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Xu, PhD | Contact | +86-13501984869 | xujmin@aiiyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Zhongshan Hospital, Fudan University | Recruiting | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C553458 | apatinib |
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The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)
| From assignment of the first subject to 3 months later after the last participant is recruited |
| DCR(disease control rate) | DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD) | From assignment of the first subject to 3 months later after the last participant is recruited |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |