Phase II Study of Anlotinib Versus Sunitinib in Patients With Advanced Renal Cell Carcinoma（RCC）

A Randomized, Positive-controlled, Multicenter, Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC)

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).

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