Multiple centers, uncontrolled, open-label, non-randomized single-arm study
To evaluate the following items in patients with metastatic pancreatic adenocarcinoma receiving GSL treatment, Primary objective: Overall tumor response rate (by RECIST criteria) Secondary objectives: Disease control rate (Objective response rate + stable disease ≧ 16 weeks) Time to tumor progression Progression-free survival Overall survival Clinical benefit response Quality of life Safety profile Biomarker of pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.
China Medical University Hospital
Taichung, Taiwan
Chang-Gung Memorial Hospital
Taipei, Taiwan
Progression-free survival (PFS)
The progression-free survival time for elderly patients with advanced pancreatic cancer
Time frame: up to 5.0 months
Overall tumor response rate
Time frame: up to 18 months
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