An open, multicenter phase II clinical study to evaluate safety and efficacy of HLX208 (BRAF V600E inhibitor) combined with cetuximab for metastatic colorectal cancer (mCRC) with BRAF V600E Mutation after first-line treatment
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
HLX208 450mg bid po OR 600mg bid po OR 900mg bid po
Cetuximab 500 mg/m2 IV Q2W
Fudan University Affiliated Oncology Hospital
Shanghai, China
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the RECIST Version 1.1)
Time frame: up to 2 years
PFS
Progression-free survival (PFS) (assessed by IRRC and the investigator as per RECIST v1.1 )
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years]
OS
Overall survival
Time frame: from the date of first dose until the date of death from any cause,assessed up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.