CLINICAL TRIAL / NCT02314819

This is a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial to compare the efficacy and safety of Fruquintinib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer who have progressed after second-line or above standard chemotherapy. After checking eligibility criteria, subjects will be randomized into Fruquintinib plus BSC group (treatment group) or placebo plus BSC group (control group) in a ration of 2:1. Primary Efficacy Endpoint: Overall Survival (OS). Secondary Efficacy Endpoints: Progression free survival (PFS) (According to RECIST Version 1.1), Objective Response Rate (ORR), Disease Control Rate (DCR), . Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 4.0.

Inclusion Criteria:

         - ≥ 18 and ≤ 75 years of age , with ≥ 40Kg

         - Histological or cytological confirmed colorectal cancer

         - ECOG performance status of 0-1

         - Standard regimen failed or no standard regimen available

         - Adequate hepatic, renal, heart, and hematologic functions

         - At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan)

         - Signed and dated informed consent

         - Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure

        Exclusion Criteria:

         - - Pregnant or lactating women

         - Any factors that influence the usage of oral administration

         - Evidence of CNS metastasis

         - Intercurrence with one of the following: non-controlled hypertension, coronary artery disease, arrhythmia and heart failure

         - Abuse of alcohol or drugs

         - Less than 4 weeks from the last clinical trial - Previous treatment with VEGFR inhibition

         - Disability of serious uncontrolled intercurrence infection

         - Proteinuria ≥ 2+ (1.0g/24hr)

         - Have evidence or a history of bleeding tendency within two months of the enrollment, regardless of seriousness

         - Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack) etc.

         - Within 6 months before the first treatment occurs acute myocardial infarction, acute coronary syndrome or CABG

         - Bone fracture or wounds that was not cured for a long time

         - Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy