colorectal cancer
Conditions
Interventions
Experimental group:The dose of fuquinitinib was 5mg, qd po, d1-14, q3w
The dose of capecitabine was 1000mg/m2, bid po, d1-14, q3w.
Sponsors
Shanghai East Hospital ;Shanghai Tenth People’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients voluntarily participate in the study, sign the informed consent, and have good compliance; 2. At least 18 years old; 3. Histologically and/or cytologically proven inoperable or metastatic colorectal cancer (stage IV); 4. If the first-line chemotherapy regimen is a 2-week regimen, patients need to undergo =8 cycles of first-line standard chemotherapy After treatment with FOLFOX,FOLFIRI,FOLFOXIRI+ bevacizumab, the disease achieved complete response, partial response or stable disease, and remained unresectable. If a patient's first-line chemotherapy regimen is a 3-week regimen, the patient needs to achieve complete response, partial response or stable disease after =4 cycles of first-line standard chemotherapy (XELOX, XELIRI+ bevacizumab), and the disease is still in an unresectable state. 5. Patients must have at least one measurable lesion before first-line treatment (RECIST 1.1); 6.ECOG physical condition 0-1 score; 7. Expected survival =12 weeks; 8. Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value =1.0×109/L, platelet =75×109/L, hemoglobin concentration =9g/dL); 2) Liver function test (aspartate aminotransferase and glutamic aminotransferase =3×ULN, bilirubin =1.5×ULN; In case of liver metastasis, AST and ALT=5×ULN); 3) Renal function (serum creatinine =1.5×ULN, or creatinine clearance (CCr)=60ml/min); 4) Coagulation, International standardized ratio (INR) =1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) =1.5×ULN; 9. Women of childbearing age must use effective contraceptive methods; 10. The subject is capable of understanding, agreeing, and signing the study Informed Consent Form (ICF) before initiating any project-related procedures; Subject may express consent with parental/guardian consent (if applicable)
Exclusion criteria
Exclusion criteria: 1.BRAF mutant; 2. Had a surgical procedure within the first 4 weeks of treatment; Received radiation therapy, radiofrequency, chemotherapy, immunoor molecular targeted therapy or other investigational drugs within 2 weeks prior to treatment; 3. Previously received anti-vascular small-molecule targeted drug therapy, such as fuquitinib, regorafenib, etc.; 4. A history of severe intolerance to capecitabine or 5-Fu (i.e., grade 4 toxicity of one of the drugs; Grade 3-4 toxicity of other concurrent drugs is not excluded); 5. Symptomatic brain or meningeal metastases (except those with brain metastases that have been treated with local radiotherapy or surgery for more than 6 months and whose disease control is stable). 6. Have high blood pressure that is not well controlled by antihypertensive medication (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg); 7. Significant clinical bleeding symptoms or significant bleeding tendency within 3 months prior to treatment (bleeding within 3 months > 30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks > 5 mL of fresh blood), etc. Or treatment of venous/venous thrombosis events within the preceding 6 months, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, or long-term antiplatelet therapy (aspirin =300 mg/day or clopidogrel =75 mg/day) is required; 8. Active heart disease, including myocardial infarction, severe/unstable angina in the 6 months prior to treatment. Left ventricular ejection fraction by echocardiography 1.0g.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Disease control rate;safety; | — |
Countries
China
Contacts
Public ContactGao Yong
Shanghai East Hospital
Outcome results
None listed