Status:
UNKNOWN
Fruquintinib Plus Capecitabine Versus Bevacizumab Plus Capecitabine as Maintenance Therapy Following First-line Treatment for Metastatic Colorectal Cancer
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is an open-label, multicenter, randomized phase 2 study evaluating the efficacy and safety of fruquintinib plus capecitabine versus bevacizumab plus capecitabine as maintenance therapy following ...
Eligibility Criteria
Inclusion
- 18-75 years old (including 18 and 75) at the time of signing the informed consent;
- Patients who have been histologically or cytologically confirmed adenocarcinoma of the colon or rectum (stage IV);
- Patients who have achieved disease control (including CR/PR and SD) after 4-6 months of first-line standard chemotherapy (FOLFOX, FOLFIRI, XELOX ± targeted therapy) and are progression free at the start of maintenance therapy;
- At least one measurable metastatic lesion(s) as defined by RECIST version 1.1;
- ECOG performance status of 0-1;
- Body weight ≥40Kg;
- LVEF≥50%;
- Life expectancy≥3 months;
- Adequate organ and bone marrow functions:
- Neutrophils \>1.5×109/L, platelets \>100×109/L, and hemoglobin \>9 g/dL; Total bilirubin \<1.5×upper limit of normal (ULN); aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and/or alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) \<2.5×ULN (\<5×ULN in case of liver metastases); Creatinine clearance (calculated according to Cockcroft and Gault) ≥50 mL/min; Urinary protein / creatinine ratio \< 1 (or urine analysis \< 1 + or 24-hour urinary protein \< 1g / 24 h);
- Able to take oral medication;
- Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion
- Pregnant or lactating women;
- Any factors that influence the usage of oral administration;
- Those who have been proved to be allergic to fruquintinib and / or its excipients;
- Blood transfusion was performed within 1 week before randomization;
- Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg;
- Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
- Clinically significant electrolyte abnormality;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Previous treatment with VEGFR inhibition;
- Evidence of CNS metastasis;
- Severe intolerance to capecitabine or 5-FU;
- Disability of serious uncontrolled intercurrence infection;
- Uncontrolled hemorrhage in GI;
- Have evidence or a history of bleeding tendency within two months of the enrollment;
- Abdominal fistula or gastrointestinal perforation occurred within 6 months before the first treatment, unless repaired by surgery;
- Within 12 months before the first treatment occurs artery/venous thromboembolic events, such as cerebral vascular accident (including stroke and transient ischemic attack) , etc.;
- Within 6 months before the first recruitment occurs acute myocardial infarction, acute coronary syndrome or CABG;
- Incomplete healing of skin trauma, surgical site, wound site or severe mucosal ulcer. Bone fracture or wounds that was not cured for a long time;
- APTT and /or PT \>1.5×ULN;
- Clinically detectable secondary primary malignancies at the time of enrollment, or had other malignancies in the past 5 years (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Patients who are not suitable for the study judged by the researchers.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT04733963
Start Date
March 1 2021
End Date
February 1 2023
Last Update
July 26 2022
Active Locations (1)
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1
the Second Affiliated Hospital of Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310000