This is a phase 2 study to investigate the efficacy and safety of Pemigatinib in treating patients with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 rearrangement who have failed at least 1 previous therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
Pemigatinib will be self-administered at 9mg Or 13.5mg as a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Objective response rate per RECIST 1.1
Time frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months
PFS(PFS= first dose to progressive disease or death)
Time frame: Time from first treatment to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
DOR(DOR= time from the date of CR or PR until PD)
Time frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months
DCR(DCR=CR + PR + stable disease)
Time frame: Every 6 weeks for the first 2 cycles and every 9 weeks thereafter through end of treatment, up to 24 months
OS(OS= first dose to death of any cause)
Time frame: Time from first treatment to the date of death from any cause, up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.