Status:
UNKNOWN
A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
Lead Sponsor:
Beijing Friendship Hospital
Conditions:
Unresectable Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic...
Detailed Description
Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for ...
Eligibility Criteria
Inclusion
- ≥18 years old at the time of signing the informed consent;
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
- Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
- Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
- At least one measurable lesion(s);
- ECOG PS 0-2;
- Life expectancy≥3 months;
- Adequate organ and bone marrow functions;
- 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 able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion
- Previous treatment with VEGFR inhibition;
- Participating in other drug clinical trials within 4 weeks before recruited;
- Have received other systemic anti-tumor therapies within 4 weeks before recruited;
- Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Clinically significant electrolyte abnormality;
- Clinically significant cardiovascular diseases;
- Thromboembolism or arteriovenous events occurred 6 months before recruited;
- ≥grade 3 bleeding events 4 weeks before recruited;
- Evidence of CNS metastasis;
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
- Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
- History of organ transplantation;
- APTT \>1.5×ULN or INR\>1.5;
- History of HIV infection or active hepatitis B / C;
- Allergic to fruquintinib and / or capecitabine;
- Pregnant or lactating women;
- Clinically detectable secondary primary malignancies at the time of enrollment (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 :
December 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT04866108
Start Date
December 8 2021
End Date
June 1 2024
Last Update
August 18 2022
Active Locations (1)
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1
Beijing Friendship Hospital
Beijing, China