Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

Prior treatment

• Previous treatment with Tegafur Gimeracil Oteracil ;
• Participated in clinical trials of other drugs within four weeks before enrollment;
• Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
• Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
• History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;
• Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;
• Previous treatment with VEGFR inhibition;
• Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;
• By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

Other illness

• Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
• Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;
• Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;
• Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;
• Cardiovascular diseases with significant clinical significance;
• Congestive heart failure New York Heart Association (NYHA) grade \> 2;
• Ventricular arrhythmias requiring drug treatment;
• Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;
• Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;

Lab values

• International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
• LVEF\<50%;

Other

• Pregnant or lactating women;
• Clinically significant electrolyte abnormalities;
• Evidence of CNS metastasis;
• Proteinuria ≥ 2+ (1.0g/24hr);

• ≥ 18 and ≤ 75 years of age;
• Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;
• Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
• Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
• At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
• ECOG performance status of 0-1;
• Life expectancy ≥ 12 weeks;
• No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
• Adequate hepatic, renal, heart, and hematologic functions;
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.