Alternating Treatment With Fruquintinib and Bevacizumab Plus Capecitabine as Maintenance Therapy After First-Line Treatment in Metastatic Colorectal Cancer

Launched by NANFANG HOSPITAL, SOUTHERN MEDICAL UNIVERSITY · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to help people with metastatic colorectal cancer—cancer that has spread beyond the colon and is not removable by surgery—after they have had initial treatment. Researchers want to see if alternating between two drugs, Fruquintinib and Bevacizumab, along with another medication called Capecitabine, works better than just continuing with Bevacizumab and Capecitabine alone. About 40 participants who have shown some improvement after first-line chemotherapy will be enrolled in this study, and they will be randomly assigned to one of two treatment groups.

To participate in the trial, patients need to be between 18 and 75 years old, have confirmed metastatic colorectal cancer, and have at least one measurable tumor that has responded to previous treatment but is still not operable. They should also be able to tolerate the medications, have good blood test results, and not have severe uncontrolled health issues. Patients in this trial will receive treatment until they experience unacceptable side effects, choose to withdraw, or meet other criteria for ending their participation. Overall, the study aims to find out how well these treatments work and whether they are safe for patients.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients voluntarily participated in the study, signed the informed consent, and had good compliance;
• • 2. Age 18-75 (including 18 and 75), gender is not limited;
• • 3. Histologically and/or cytologically confirmed metastatic colorectal cancer (stage IV);
• • 4. The patient with at least one measurable lesion (RECIST 1.1) achieved partial remission after 8 cycles of first-line standard chemotherapy (FOLFOX combined with bevacizumab), and the disease remained in an unresectable state.
• • 5. ECOG performance status of 0-2 points;
• • 6. Expected survival ≥12 weeks;
• • 7. Blood test (without blood transfusion within 14 days) 1) Neutrophil absolute value ≥1.5×10\^9/L, platelet ≥100×10\^9/L, hemoglobin ≥90g/L); 2) Liver function test (aspartate aminotransferase and glutamate 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);
• • 8. Men and women of childbearing age must use effective contraceptive methods.
• Exclusion Criteria:
• • 1. Received major surgery within 4 weeks prior to the first drug administration; radiotherapy, radiofrequency ablation, chemotherapy, immunotherapy or molecular targeted therapy for tumors within 2 weeks, and other investigational drugs;
• • 2. Previously received anti-vascular small-molecule targeted drug therapy, such as fuquinitinib, regofenib, etc.;
• • 3. A history of severe intolerance to bevacizumab and capecitabine or 5-Fu (i.e., grade 4 toxicity of one of these drugs; Class 3-4 toxicity of other co-administered drugs is not excluded);
• 4. Known brain or meningeal metastases:
• • 5. Have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
• • 6. Obvious clinical bleeding symptoms or obvious bleeding tendency and hemoptysis within 3 months prior to treatment. 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;
• • 7. Active heart disease, including myocardial infarction, severe/unstable angina in the 6 months prior to treatment. Echocardiography showed that the left ventricular ejection fraction was less than 50%, indicating poor arrhythmia control.
• • 8. The patient had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within the previous 5 years or at the same time;
• • 9. Known allergy to the study drug or any of its excipients;
• • 10. Severe active infection or uncontrolled infection;
• • 11. Any other disease, a clinically significant metabolic abnormality, abnormal physical examination or abnormal laboratory examination, for which, in the investigator's judgment, there is reason to suspect that the patient has a disease or condition unsuitable for the use of the investigational agent;
• • 12. Urine routine indicated urine protein ≥2+, and 24 hours urine protein quantity \>1.0g.