This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA (body surface area)\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA(body surface area) \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Progression Free Survival (PFS)
PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Objective response rate(ORR)
Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Disease control rate(DCR)
DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years
Overall survival (OS)
OS is the time from enrollment to death due to any cause.
Time frame: from randomization up to progressive disease or EOT due to any cause, up to 3 years
adverse events (AE)
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Time frame: from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib
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