Chemotherapeutic Toxicity, Chemotherapy Effect, Pancreatic Cancer
Conditions
Brief summary
Gemcitabine plus S-1 (GS) prolonged progression-free survival (PFS) and greatly improved objective response rate (ORR) as well as disease control rate (DCR) of Asian patients with locally advanced and metastatic pancreatic cancer (PC). However, limited data of GS regimen exist on the efficacy and safety in the treatment of Chinese patients with advanced PC. To assess the efficacy and safety of gemcitabine plus S-1 (GS regimen) as the first-line chemotherapy in Chinese patients with advanced PC, we designed this prospective study.
Interventions
DRUGGS
Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer
Sponsors
Zhejiang University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1.Histologically confirmed pancreatic adenocarcinoma 2.Locally advanced or metastatic PC 3.Chemotherapy-naïve 4.ECOG performance status of 0 or 1 5. An adequate bone marrow, liver function and kidney function
Exclusion criteria
* 1.Age ≥80 years 2.Brain metastasis 3.With other malignancies 4.Chronic diarrhea, cardiac disease, pregnancy or breast feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 2014-01-01 to 2017-12-31 | the time from the beginning of chemotherapy to the date of disease progression or death from any cause. |
| Overall survival | 2014-01-01 to 2017-12-31 | the time from the beginning of chemotherapy to the date of death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 2014-01-01 to 2017-12-31 | the percentage of patients with CR or PR |
| adverse events | 2014-01-01 to 2017-12-31 | — |
Countries
China
Outcome results
None listed