* Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3. Phase I study has shown that the toxicity is manageable.
* The purpose of this study is to compare the efficacy and safety profile between Famitinib and Sunitinib in patients with metastatic renal cell carcinoma.
Inclusion Criteria:
* Patients with histologically confirmed advanced renal cell carcinoma including clear cell component and not available for surgery
* First-line therapy or second-line treatment (second-line treatment e.g chemotherapy or cytokine therapy as first-line treatment failure or resistant patients)
* With measurable disease (using RECIST1.0 standard conventional CT scan ≥ 20 mm, spiral CT scan ≥ 10mm, target lesion did not receive radiation therapy, cryotherapy)
* Male or female, age ≥18 and ≤75
* ECOG 0-1
* Life expectancy ≥ 3 months
* Subjects received surgery, chemotherapy, radiation therapy, cytokines treatment caused the damage has been restored, the time interval ≥ 4 weeks, and the wound has completely healed
* Normal major organ function
* Signed and dated informed consent
Exclusion Criteria:
* Previously received targeted therapy of the metastatic renal cell carcinoma (such as sunitinib, Sorafenib)
* Past or suffering from other cancer, but other than cure basal cell carcinoma and cervical carcinoma in situ
* Participated in other clinical trials within four weeks
* A variety of factors that affect the oral medication (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction)
* Known brain metastases, spinal cord compression, cancer, meningitis, or screening CT or MRI examination revealed brain or leptomeningeal disease
* Patients with hypertension (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg). Patients with more than Class I, myocardial ischemia or myocardial infarction, arrhythmia (including QT interval ≥ 440ms) and class I heart failure.
* Urine protein ≥ + + and confirmed the 24-hour urinary protein\>1.0 g
* Coagulopathy with bleeding tendency (such as active peptic ulcer) or are receiving thrombolytic or anticoagulant therapy
* Previous hyperactivity / venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism
* The preexisting abnormal thyroid function, even in the case of medication still can not be maintained within the normal range
* With a history of abuse of psychotropic drugs or mental disorders
* Patients with Hepatitis B or Hepatitis C
* History of immunodeficiency, including HIV testing positive or suffering from acquired, congenital immunodeficiency disease, or a history of organ transplantation
Locations (1)
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Beijing, China
Outcomes
Primary Outcomes
Objective Response Rate
Time frame: 18 weeks
Secondary Outcomes
Progress free survival (PFS)
Time frame: 3 years
Disease Control Rate (DCR)
Time frame: 3 years
Overall Survival (OS)
Time frame: 3 years
Quality of Life
Time frame: 42-day cycle visit until disease progress
Number of Participants with Adverse Events as a Measure of Safety