Study of Fuquinitinib Combined With Capecitabine First-line Maintenance in the Treatment of Metastatic Colorectal Cancer

NANot yet recruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

December 28, 2023

Primary Completion Date

December 15, 2026

Study Completion Date

December 31, 2026

Conditions
Colorectal Carcinoma
Interventions
DRUG

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."

All Listed Sponsors
lead

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

NCT06115733 - Study of Fuquinitinib Combined With Capecitabine First-line Maintenance in the Treatment of Metastatic Colorectal Cancer | Biotech Hunter | Biotech Hunter