56
Participants
Start Date
December 28, 2023
Primary Completion Date
December 15, 2026
Study Completion Date
December 31, 2026
Fruquintinib、Capecitabine Tablets
"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."
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
OTHER