This is a real-world study. Patients with metastatic colorectal cancer who have progressed (PD) after third-line treatment with fruquintinib combined with PD-1 inhibitors will receive fruquintinib combined with TAS-102 as fourth-line therapy. The objective of this study was to observe the efficacy and safety of cross-line(from third to fourth line)treatment with fruquinitinib.
This is a real-world study. Patients with metastatic colorectal cancer confirmed by histopathology had previously received 2-line system therapy with fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquinitinib combined with PD-1 inhibitors for third-line treatment. After progression (PD) (confirmed by RECIST 1.1 ), fruquinitinib combined with TAS-102 as fourth-line therapy was received. The primary endpoint was observation the overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102. The study objective is to explore the possibility of cross-line rechallenge of fruquinitinib.
Study Type
OBSERVATIONAL
Enrollment
36
Third-line treatment with fruquintinib combined with PD-1 inhibitors. Fruquintinib: 5mg,Oral once daily,2 weeks on/1 week off,Q3W; PD-1 inhibitor:for example, Sintilimab,iv,200mg, Q3W.
Fourth-line treatment with fruquintinib combined with TAS-102 . Fruquintinib: 3-5mg(Depending on the patient's physical condition), Oral once daily,3 weeks on/1 week off,Q4W; TAS-102:orally, 35mg/m2 twice daily (maximum dose 80mg in a single dose) for days 1-5, repeated every 14 days.
TONGJI Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGZhongnan Hospital of Wuhan University
Wuhan, Hubei, China
RECRUITINGOverall survival 2(OS2)
Overall survival (OS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Time frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented date of death from any cause , assessed up to 12 months
Objective response rate 2(ORR2, investigator based on RECIST1.1)
Objective response rate (ORR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Time frame: from received fruquinitinib combined with TAS-102 to one year
Progression-free survival 2(PFS2, investigators based on RECIST1.1)
Progression-free survival (PFS) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Time frame: From the date of first fruquinitinib combined with TAS-102 treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Disease control rate 2 (DCR2, investigators based on RECIST1.1)
Disease control rate (DCR) of fourth-line treatment of mCRC with fruquinitinib and TAS-102
Time frame: from received fruquinitinib combined with TAS-102 to one year
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