Phase II Study of Anlotinib in Patients With Advanced Renal Cell Carcinoma That Have Failed Or Are Intolerant To TKIs Therapy

Study Overview
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Brief Summary
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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 explore the efficacy and safety profile of Anlotinib in patients with advanced Renal Cell Carcinoma(RCC) that have failed to TKIs therapy.

Official Title
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A Phase II Study of Anlotinib(AL3818) in Patients With Advanced Renal Cell Carcinoma(RCC) That Have Failed Or Are Intolerant To TKIs Therapy

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anlotinib<br>Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Anlotinib<br>* Anlotinib p.o. qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | 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. | each 42 days up to intolerance the toxicity or PD (up to 36 months) | 
| Disease Control Rate (DCR) | 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). | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Cell Carcinoma（RCC）, Anlotinib