Last updated: January 4, 2023
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting
Phase
2
Condition
Colorectal Cancer
Metastatic Cancer
Treatment
N/AClinical Study ID
NCT05659290
NFEC-2022-479
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients voluntarily participated in the study, signed the informed consent, and hadgood compliance;
- Age 18-75 (including 18 and 75), gender is not limited;
- Histologically and/or cytologically confirmed metastatic colorectal cancer (stage IV);
- The patient with at least one measurable lesion (RECIST 1.1) achieved partialremission after 8 cycles of first-line standard chemotherapy (FOLFOX combined withbevacizumab), and the disease remained in an unresectable state.
- ECOG performance status of 0-2 points;
- Expected survival ≥12 weeks;
- 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);
- Men and women of childbearing age must use effective contraceptive methods.
Exclusion
Exclusion Criteria:
- Received major surgery within 4 weeks prior to the first drug administration;radiotherapy, radiofrequency ablation, chemotherapy, immunotherapy or moleculartargeted therapy for tumors within 2 weeks, and other investigational drugs;
- Previously received anti-vascular small-molecule targeted drug therapy, such asfuquinitinib, regofenib, etc.;
- A history of severe intolerance to bevacizumab and capecitabine or 5-Fu (i.e., grade 4toxicity of one of these drugs; Class 3-4 toxicity of other co-administered drugs isnot excluded);
- Known brain or meningeal metastases:
- Have hypertension that is not well controlled by antihypertensive medications (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg);
- Obvious clinical bleeding symptoms or obvious bleeding tendency and hemoptysis within 3 months prior to treatment. Or treatment of venous/venous thrombosis events withinthe preceding 6 months, such as cerebrovascular accidents (including transientischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis andpulmonary embolism; Long-term anticoagulant therapy with warfarin or heparin, orlong-term antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day) isrequired;
- Active heart disease, including myocardial infarction, severe/unstable angina in the 6months prior to treatment. Echocardiography showed that the left ventricular ejectionfraction was less than 50%, indicating poor arrhythmia control.
- The patient had other malignancies (except cured basal cell carcinoma of the skin andcarcinoma in situ of the cervix) within the previous 5 years or at the same time;
- Known allergy to the study drug or any of its excipients;
- Severe active infection or uncontrolled infection;
- Any other disease, a clinically significant metabolic abnormality, abnormal physicalexamination or abnormal laboratory examination, for which, in the investigator'sjudgment, there is reason to suspect that the patient has a disease or conditionunsuitable for the use of the investigational agent;
- Urine routine indicated urine protein ≥2+, and 24 hours urine protein quantity >1.0g.
Study Design
Total Participants: 40
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025
Connect with a study center
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong 510515
ChinaActive - Recruiting
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