metastatic colorectal cancer
Conditions
Interventions
Fruquintinib:None
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old (inclusive); 2. Advanced metastatic colorectal adenocarcinoma confirmed by histopathological examination; 3. Patient has received prior first-line standard therapy with targeted agents (bevacizumab or cetuximab) in combination with chemotherapy (fluorouracil, oxaliplatin, and/or irinotecan) for 4-6 months without progression on tumor evaluation. 4. Must have at least one measurable lesion, with a diameter of at least 10mm in the longest part as measured by spiral contrast CT scan and at least 20mm in diameter as measured by conventional CT scan (Efficacy Evaluation Criteria for Solid Tumors, i.e., RECIST version 1.1); 5. ECOG performance status 0-1 points; 6. Expected survival time>=12 weeks; 7. The function of vital organs within 7 days prior to enrollment meets the following requirements (not allowed within 14 days prior to enrollment Use of any blood components and cell growth factors): - Absolute neutrophil count >= 1.5×10^9/L; - Platelet >= 80×10^9/L; - hemoglobin >=8 g/dL; Total bilirubin 50 ml/min; 8. Women of childbearing age should use effective contraception; 9. Good compliance and cooperation with follow-up.
Exclusion criteria
Exclusion criteria: 1. Participation in other drug clinical trials within 4 weeks prior to screening; 2. Receipt of any systemic anti-tumor therapy other than the standard regimen within 4 weeks prior to screening, including chemotherapy, signal transduction inhibitors, hormonal therapy, and immunotherapy; 3. Electrolyte abnormalities judged by the investigator as clinically significant; 4. Unresolved toxicities from prior anti-cancer therapy exceeding CTCAE v5.0 Grade 1 (except alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity = Grade 2), or a history of arterial/venous thrombosis within 6 months before screening; 5. Clinically significant cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to maintenance therapy; 6. Congestive heart failure with New York Heart Association (NYHA) class > Grade 2; 7. Ventricular arrhythmias requiring medical treatment; 8. Left ventricular ejection fraction (LVEF) <50% (measured by echocardiography); 9. History of other malignancies within the past 5 years (excluding radically resected basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); 10. Presence of central nervous system (CNS) metastases or history of brain metastases; 11. Any concurrent illness that, in the investigator’s judgment, seriously endangers patient safety or compromises study completion; 12. Patients deemed ineligible for the study by the investigator. Abbreviations: CTCAE = Common Terminology Criteria for Adverse Events NYHA = New York Heart Association LVEF = Left Ventricular Ejection Fraction CNS = Central Nervous System
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free Survival; | — |
Countries
China
Contacts
Public ContactJianjun Peng
The First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed