study of fruquintinib combined with tegafur gimeracil oteracil in patients with metastatic colorectal cancer

Conditions: Metastasis Colorectal Cancer; Colon Cancer; Rectal Cancer

Summary: this is an open, single-arm, multicenter, prospective phase ii study of fuquinitinib combined with tegafur gimeracil oteracil in the third-line treatment of patients with advanced metastatic crc


Eligibility criteria:
inclusion criteria: 1. ≥ 18 and ≤ 75 years of age; 2. 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; 3. histologically and/or cytologically documented metastatic colorectal adenocarcinoma; 4. refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan; 5. at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan or 20mm by conventional ct scan); 6. ecog performance status of 0-1; 7. life expectancy ≥ 12 weeks; 8. no previous treatment with vascular endothelial growth factor receptor (vegfr) inhibitor (tki); 9. adequate hepatic, renal, heart, and hematologic functions; 10. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. exclusion criteria: 1. pregnant or lactating women; 2. any factors that influence the usage of oral administration or any disease or condition that affects drug absorption; 3. previous treatment with tegafur gimeracil oteracil ; 4. participated in clinical trials of other drugs within four weeks before enrollment; 5. received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy; 6. international normalized ratio (inr) \> 1.5 or partially activated prothrombin time (aptt) \> 1.5 × uln; 7. clinically significant electrolyte abnormalities; 8. 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; 9. unrelieved toxic reactions higher than ctcae v5.0 grade 1 caused by any previous anti-cancer treatment; 10. incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture; 11. conditions that may cause gastrointestinal bleeding and perforation determined by the researcher; 12. history of arterial thrombosis or deep venous thrombosis within 6 months before enrollment; 13. stroke and / or transient cerebral ischemia occurred within 12 months before enrollment; 14. cardiovascular diseases with significant clinical significance; 15. lvef\<50%; 16. congestive heart failure new york heart association (nyha) grade \> 2; 17. evidence of cns metastasis; 18. previous treatment with vegfr inhibition; 19. ventricular arrhythmias requiring drug treatment; 20. proteinuria ≥ 2+ (1.0g/24hr); 21. coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy; 22. other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ; 23. active infection that is not controlled clinically, such as acute pneumonia, active hepatitis b or hepatitis c; 24. by judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

Keywords: colorectal cancer fruquintinib tegafur gimeracil oteracil mcrc