Clinical trial NCT02072031: Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）
Official title: A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Anlotinib
RCC
Keywords: Anlotinib
Sunitinib
Renal Cell Carcinoma（RCC）
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
* 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:

* 1.Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
* 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

Primary outcomes:
measure: Progress free survival (PFS)
timeFrame: each 42 days up to PD or death(up to 36 months)
Secondary outcomes:
measure: Objective Response Rate
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
measure: Disease Control Rate (DCR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 36 months)
measure: Overall Survival (OS)
timeFrame: From randomization until death (up to 36 months)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Province Tumor Hospital
state: Gansu
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi medical university affiliated tumor hospital
state: Guangxi
city: Haerbin
country: China
facility: Harbin medical university affiliated tumor hospital
state: Heilongjiang
city: Nanjing
country: China
facility: The 81st Hospital of Chinese PLA
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: China General Hospital of Shenyang Military Region
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Province Tumor Hospital
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital，Shandong University
state: Shandong
city: Shanghai
country: China
facility: Cancer Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital
state: Tianjin
Study officials:
References: