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The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration(SFDA:2011L00661) which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Active Comparator | Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Placebo | Placebo Comparator | Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib p.o. qd |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From randomization until death (up to 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progress free survival (PFS) | each 42 days up to PD or death(up to 24 months) | |
| Objective Response Rate (ORR) | each 42 days up to intolerance the toxicity or PD (up to 24 months) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yihebali Chi, doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Jianqiang Cai, doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Jinwan Wang, doctor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | |||
| The Second Affiliated Hospital, Anhui Medical University |
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| Label | URL |
|---|---|
| Cancer | View source |
| Colorectal Cancer | View source |
| U.S. FDA Resources |
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| Placebo |
| Drug |
Placebo p.o. qd |
|
| Disease Control Rate (DCR) |
| each 42 days up to intolerance the toxicity or PD (up to 24 months) |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Until 30 day safety follow-up visit |
| Hefei |
| Anhui |
| China |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
| The 307th Hospital of Chinese People's Liberation Army | Beijing | Beijing Municipality | China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| Fujian Cancer Hospital | Fuzhou | Fujian | China |
| Gansu Province Tumor Hospital | Lanzhou | Gansu | China |
| The First Affiliated Hospital of Sun Yat-sen university | Guangzhou | Guangdong | China |
| The Sixth Affiliated Hospital of Sun Yat-sen university | Guangzhou | Guangdong | China |
| Guangxi medical university affiliated tumor hospital | Nanning | Guangxi | China |
| Harbin medical university affiliated tumor hospital | Haerbin | Heilongjiang | 150000 | China |
| The Second xiangya Hospital of Central South University | Changsha | Hunan | China |
| The First People's Hospital of Lianyungang | Lianyungang | Jiangsu | China |
| Jiangsu Cancer Hospital | Nanjing | Jiangsu | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
| Nantong Cancer Hospital | Nantong | Jiangsu | China |
| Jiangxi Cancer Hospital | Nanchang | Jiangxi | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China |
| Jilin Cancer Hospital | Changchun | Jilin | China |
| Liaoning Province Tumor Hospital | Shenyang | Liaoning | China |
| Qilu Hospital,Shandong University | Jinan | Shandong | China |
| Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | China |
| Shanxi Cancer Hospital | Xian | Shanxi | China |
| Tangdu Hospital of The fourth Military Medical University | Xian | Shanxi | China |
| The First Affiliated Hospital of Xian Jiaotong University | Xian | Shanxi | China |
| Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | China |
| The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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