Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy
- Registration Number
- NCT02072044
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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 explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 1.Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
- 2.Previously Failed Or Are Intolerant To TKIs Therapy(such as sunitinib, Sorafenib)
- 3.With measurable disease (using RECIST1.1)
- 4.18-75years,ECOG PS:0-1,Life expectancy of more than 3 months
- 5.Last TKIs Therapy≥4 weeks
- 6.Main organs function is normal
- 7.Signed and dated informed consent
- 1.patients has many influence factors toward oral medications
- 2.Known brain metastases
- 3.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.
- 4.patients failed to heal wounds or fractures for Long-term
- 5.patients occurred venous thromboembolic events within 6 months
- 6.patients has HIV-positive or organ transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Anlotinib Anlotinib Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- Primary Outcome Measures
Name Time Method Progress Free Survival (PFS) each 42 days up to PD or death (up to 36 months) 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"
- Secondary Outcome Measures
Name Time Method Objective Response Rate each 42 days up to intolerance the toxicity or PD (up to 36 months) 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.
Overall Survival (OS) From randomization until death (up to 36 months) 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.
Disease Control Rate (DCR) each 42 days up to intolerance the toxicity or PD (up to 36 months) 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).
Trial Locations
- Locations (15)
Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
The 81st Hospital of Chinese PLA
🇨🇳Nanjing, Jiangsu, China
Liaoning Province Tumor Hospital
🇨🇳Shenyang, Liaoning, China
Gansu Province Tumor Hospital
🇨🇳Lanzhou, Gansu, China
West China Hospital，Sichuan University
🇨🇳Chengdu, Sichuan, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Guangxi medical university affiliated tumor hospital
🇨🇳Nanning, Guangxi, China
Harbin medical university affiliated tumor hospital
🇨🇳Haerbin, Heilongjiang, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
China General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
Qilu Hospital，Shandong University
🇨🇳Jinan, Shandong, China