This is a single-arm, single-center, prospective phase I/II study that received standard first-line chemotherapy (FOLFOX,FOLFIRI,XELOX, FOLFOXIRI± targeted therapy). If the first-line chemotherapy regimen is a 2-week regimen, patients need to undergo ≥8 cycles of standard chemotherapy. If the first-line chemotherapy regimen is a 3-week regimen, maintenance therapy is required for patients with unresectable advanced metastatic colorectal cancer who have reached CR,PR,SD (RECIST 1.1) after standard chemotherapy after ≥4 cycles. The eligible patients were screened for maintenance treatment. Maintenance therapy research is divided into the following two phases: Phase IIB fuquinitinib combined capecitabine dose exploration trial (n=6-9) : Phase II: Dose extension trial (n=47) : 47 patients were continued to be enrolled in the dose extension phase trial according to the recommended dose of fuquinitinib combined with capecitabine established in phase iB, and were treated until toxicity became intolerable or disease progression.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Phase Ⅰb dose exploration trial of fuquinitinib combined with capecitabine (n=6-9) : 3\) Capecitabine: 1000 mg/m² orally, twice a day on days 1-21 of each cycle, 28 days for one treatment cycle. 4\) Fuquinitinib: 1 to 21 days per cycle, orally, once a day, 28 days for a treatment cycle. There are two dose gradients of fuquintinib: 2mg/d, and the initial dose of 3mg/d is 2mg/d. According to the 3+3 dose climbing principle, dose exploration is carried out in the order of 2mg/d→3mg/d, as follows: Phase II: Dose extension trial (n=47) : The recommended dose of fuquinitinib combined with capecitabine, as determined in phase I b, continued to enroll 47 patients in the dose-expansion phase trial until the patient became intolerant of toxicity or disease progression.
RP2D
Recommended dose for Phase II study
Time frame: RP2D is defined as approximately 4 months from the date of enrollment to the end of the study or the date of first recorded progress or the date of death from any cause, whichever comes first
PFS
Progression-Free Survival
Time frame: PFS is defined as approximately 12 months from the date of enrollment until the date of first recorded progress or the date of death from any cause, whichever comes first
ORR
Objective Response Rate
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
OS
overall survival
Time frame: OS From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36months
DCR
Disease control rate
Time frame: From date of enrollment until the end of treatment or the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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