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The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.
Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| paclitaxel liposome + S-1 | Experimental | paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area(<1.25m^2,40mg Bid;1.25~1.5m^2,50mg Bid;>1.50m^2,60mg Bid,d1-14,q3w) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel liposome | Drug | Patients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. | from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | To evaluate the Overall Response Rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. | from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xian-Jun Yu, M.D., Ph.D. | Contact | +86 21 64175590 | yuxianjun@fudanpci.org |
| Name | Affiliation | Role |
|---|---|---|
| Xian-Jun Yu, M.D., Ph.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China | Shanghai | 200032 | China |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
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| S-1 | Drug | Patients receive S-1 at a dose according to the body surface area(<1.25m^2,40mg Bid;1.25~1.5m^2,50mg Bid;>1.50m^2,60mg Bid)on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity,death or begin a novel therapeutic. |
|
To evaluate the overall survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. |
| from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months |
| Disease control rate | To evaluate the disease control rate of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. | from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months |
| Quality of life (Qol) | To evaluate the Quality of Life of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. | from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months |
| Adverse events | To evaluate the adverse events of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1. | from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months |