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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 compare the efficacy and safety profile between Anlotinib and Sunitinib in patients with advanced Renal Cell Carcinoma(RCC).
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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 |
|
| Sunitinib maleate | Active Comparator | Sunitinib 50 mg qd p.o., 4 weeks out of 6.The treatment continued until disease progression or intolerable toxicity happened or patients withdrawal of consent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Anlotinib p.o. qd |
| |
| Sunitinib maleate |
| 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 or Sunitinib maleate by enhanced CT/MRI scan every cycle. 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 |
|---|---|---|---|
| 36749752 | Derived | Lin J, Fang Q, Zheng X. Cost-effectiveness analysis of anlotinib versus sunitinib as first-line treatment for metastatic renal cell carcinoma in China. PLoS One. 2023 Feb 7;18(2):e0281402. doi: 10.1371/journal.pone.0281402. eCollection 2023. |
| Label | URL |
|---|---|
| NLM | View source |
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| Drug |
Sunitinib 50 mg p.o. qd |
|
| Disease Control Rate (DCR) | To evaluate the effectiveness of Anlotinib Hydrochloric Capsule by enhanced CT/MRI scan every two cycles or Sunitinib maleate by enhanced CT/MRI scan every cycle. 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 |
| Druginfo | View source |
| Sunitinib | View source |
| ID | Term |
|---|---|
| C000625192 | anlotinib |
| D000077210 | Sunitinib |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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