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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. Anlotinib is a kinase inhibitor of receptor tyrosine with multi-targets, especially for VEGFR2、VEGFR3、PDGFRβ and c-Kit. It has the obvious resistance to new angiogenesis. The trial is to explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anlotinib | Experimental | Anlotinib 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 |
|---|---|---|
| Progress Free Survival (PFS) | The PFS time is defined as time from randomization to locoregional or systemic recurrence, second malignancy or death due to any cause; censored observations will be the last date of: "death", "last tumor assessment", "last follow up date" or "last date in drug log" | each 42 days up to PD or death (up to 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients. | each 42 days up to intolerance the toxicity or PD (up to 36 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100005 | China | ||
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32457838 | Derived | Ma J, Song Y, Shou J, Bai Y, Li H, Xie X, Luo H, Ren X, Liu J, Ye D, Bai X, Fu C, Qin S, Wang J, Zhou AP. Anlotinib for Patients With Metastatic Renal Cell Carcinoma Previously Treated With One Vascular Endothelial Growth Factor Receptor-Tyrosine Kinase Inhibitor: A Phase 2 Trial. Front Oncol. 2020 May 7;10:664. doi: 10.3389/fonc.2020.00664. eCollection 2020. |
| Label | URL |
|---|---|
| Cancer | View source |
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| Disease Control Rate (DCR) | To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease). | each 42 days up to intolerance the toxicity or PD (up to 36 months) |
| Overall Survival (OS) | OS was defined as time from date of randomization to date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive. | From randomization until death (up to 36 months) |
| Beijing |
| Beijing Municipality |
| 100021 |
| China |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 404100 | China |
| Gansu Province Tumor Hospital | Lanzhou | Gansu | 730050 | China |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| Guangxi medical university affiliated tumor hospital | Nanning | Guangxi | 530021 | China |
| Harbin medical university affiliated tumor hospital | Haerbin | Heilongjiang | 150000 | China |
| The 81st Hospital of Chinese PLA | Nanjing | Jiangsu | 210000 | China |
| Jilin Cancer Hospital | Changchun | Jilin | 132000 | China |
| China General Hospital of Shenyang Military Region | Shenyang | Liaoning | 110000 | China |
| Liaoning Province Tumor Hospital | Shenyang | Liaoning | 110042 | China |
| Qilu Hospital,Shandong University | Jinan | Shandong | 250012 | China |
| Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | 200000 | China |
| West China Hospital,Sichuan University | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Hospital | Tianjin | Tianjin Municipality | 300000 | China |
| Drug Information | View source |
| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C000625192 | anlotinib |
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