The Efficacy and Safety of Fruquintinib Plus Chemotherapy as Second-line Treatment in Metastatic Colorectal Cancer

Inclusion Criteria:

• Aged 18-75years (inclusive);
• Body weight ≥40 kg;
• Histological or cytological confirmed colorectal cancer;
• Expected survival >12 weeks;
• Fail in previous first-line standard therapy, which must include a fluorouracil (5-fluorouracil or capecitabine), oxaliplatin ;
• At least one measurable lesion (according to RECIST1.1);
• Adequate hepatic, renal, heart, and hematologic functions;
• Negative serum pregnancy test at screening for women of childbearing potential.

Exclusion Criteria:

• Received radiation therapy, surgical procedure, chemotherapy, immunotherapy ormolecular targeted therapy, or other investigational drugs within 4 weeks prior totreatment
• Prior treatment with anti-angiogenic small molecule targeted drugs, such asfruquintinib, etc
• Prior treatment with an irinotecan-based chemotherapy regimen
• Symptomatic brain or meningeal metastases (except for patients with BMS who havereceived local radiotherapy or surgery for more than 6 months and whose disease isstable);
• Patients with hypertension that cannot be well controlled by antihypertensivemedication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
• Have obvious clinical bleeding symptoms or obvious bleeding tendency within 3 monthsbefore treatment (bleeding > 30 mL within 3 months, hematemesis, black feces,hematozoia), hemoptysis (fresh blood > 5 mL within 4 weeks), etc. Treatment forvenous/venous thrombosis events within the previous 6 months, such as cerebrovascularaccident (including transient ischemic attack, cerebral hemorrhage, cerebralinfarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulanttherapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin ≥300mg/day or clopidogrel ≥75 mg/day);
• Tumor invasion of large vascular structures, such as pulmonary artery, superior venacava or inferior vena cava, was found during screening, which was judged by theinvestigator to have a greater risk of bleeding;
• Active heart disease, including myocardial infarction, severe/unstable angina, 6months prior to treatment. Echocardiography examination left ventricular ejectionfraction < 50%, arrhythmia control is not good;
• The patient has had other malignant tumors within 5 years (except cured basal cellcarcinoma of the skin and carcinoma in situ of the cervix);
• Allergy to the study drug or any of its excipients;
• Severe infection with active or uncontrolled infection;
• Any other disease, with clinical significance of metabolic abnormalities, abnormalphysical examination or laboratory abnormalities, according to researchers, there isreason to suspect the patient has not suitable for the use of study drugs of a diseaseor condition (such as have a seizure and require treatment), or will affect theinterpretation of results, or to make patients in high-risk situations;
• Urine routine showed urine protein ≥2+, and 24-hour urine protein level >1.0g.