A Phase Ib Study of Fruquintinib in 3rd Line mCRC

Inclusion Criteria:

• ≥ 18 and ≤ 70 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, laboratorytests, 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 arterydisease, 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)

• Uncontrolled hemorrhage in GI

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

• Within 6 months before the first treatment occurs acute myocardial infarction, acutecoronary syndrome or CABG

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

• Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy