A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

Inclusion Criteria: 1. ≥18 years old at the time of signing the informed consent; 2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer; 3. Haven't received systematic therapy after diagnosis of metastatic colorectal cancer; 4. Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy; 5. At least one measurable lesion(s); 6. ECOG PS 0-2; 7. Life expectancy≥3 months; 8. Adequate organ and bone marrow functions; 9. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration; 10. Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. Exclusion Criteria: 1. Previous treatment with VEGFR inhibition; 2. Participating in other drug clinical trials within 4 weeks before recruited; 3. Have received other systemic anti-tumor therapies within 4 weeks before recruited; 4. Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg; 5. Proteinuria ≥ 2+ (1.0g/24hr); 6. Clinically significant electrolyte abnormality; 7. Clinically significant cardiovascular diseases; 8. Thromboembolism or arteriovenous events occurred 6 months before recruited; 9. ≥grade 3 bleeding events 4 weeks before recruited; 10. Evidence of CNS metastasis; 11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI; 12. Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites; 13. History of organ transplantation; 14. APTT \>1.5×ULN or INR\>1.5; 15. History of HIV infection or active hepatitis B / C; 16. Allergic to fruquintinib and / or capecitabine; 17. Pregnant or lactating women; 18. Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix); 19. Patients who are not suitable for the study judged by the researchers.