A randomized multi-center phase II trial of nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine as first-Line treatment for locally advanced or metastatic pancreatic cancer
A Phase II, open-label randomized, multicenter trial to compare nab-paclitaxel in combination with gemcitabine verus S1 with gemcitabine with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with locally advanced or metastatic adenocarcinoma of the pancreas.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area \< 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area \>1.5 m²; D1-14, q3w)
Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGPFS
progression-free survival
Time frame: 6 month
OS
overall survival
Time frame: 1 year
ORR
objective response rate
Time frame: 6 month
DCR
CR+PR+SD was defined as disease control rate (DCR)
Time frame: 6 month
Safety profile :Adverse events of nab-Paclitaxel plus S-1
Adverse events of nab-Paclitaxel plus S-1
Time frame: 1 year
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