Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）
NCT ID: NCT02072031
Last Updated: 2016-04-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
133 participants
INTERVENTIONAL
2013-12-31
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Anlotinib
Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
Anlotinib
Anlotinib p.o. qd
Sunitinib maleate
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.
Sunitinib maleate
Sunitinib 50 mg p.o. qd
Interventions
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Anlotinib
Anlotinib p.o. qd
Sunitinib maleate
Sunitinib 50 mg p.o. qd
Eligibility Criteria
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Inclusion Criteria
* 2.Without drug treatment for RCC or chemotherapy/cytokine therapy failure or resistant patients)
* 3.With measurable disease (using RECIST1.1)
* 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
* 5.Other cytotoxic drugs,radiation therapy,or surgery≥4 weeks
* 6.main organs function is normal
* 7.Signed and dated informed consent
Exclusion Criteria
* 2.patients has many influence factors toward oral medications
* 3.Known brain metastases
* 4.patients with severe and failed to controlled diseases,including: suboptimal blood pressure control;suffering from myocardial ischemia or above grade I myocardial infarction, arrhythmias and Class I heart failure;activity or failure to control severe infections;liver disease such as cirrhosis, decompensated liver disease, chronic active hepatitis;poorly controlled diabetes (FBG)\>10mmol/L);urine protein≥++,etc.
* 5.patients failed to heal wounds or fractures for Long-term
* 6.patients occurred venous thromboembolic events within 6 months
* 7.patients has HIV-positive or organ transplantation
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
Guangxi medical university affiliated tumor hospital
Nanning, Guangxi, China
Harbin medical university affiliated tumor hospital
Haerbin, Heilongjiang, China
The 81st Hospital of Chinese PLA
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
China General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Qilu Hospital，Shandong University
Jinan, Shandong, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital，Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital
Tianjin, Tianjin Municipality, China
Countries
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References
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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.
Related Links
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Other Identifiers
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ALTN-06-IIA
Identifier Type: -
Identifier Source: org_study_id
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