This study is a single-arm, multi-center, open-label prospective phase II clinical study designed to evaluate the efficacy and safety of nab-paclitaxel and S-1 in patients with locally advanced pancreatic cancer. A total of 60 subjects who meet the criteria will be treated with nab-paclitaxel and S-1. The primary endpoint is 6 months progression free survival rate, and secondary endpoints include objective response rate, overall survival, progression free survival and toxicities.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Nab-paclitaxel: 120 mg/m2 d1, 8, S-1:Body surface area \< 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 , \< 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITING6-month progression-free survival (PFS)
The proportion of patients who did not experience disease progression or die from disease progression within 6 months from the registration.
Time frame: 6 months
Objective Response Rate (ORR)
Refers to the proportion of patients with partial tumor remission (PR) and complete remission (CR).
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
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