Nab-paclitaxel Plus S-1 in Patients With Advanced Pancreatic Cancer (NAPSPAC)
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|ClinicalTrials.gov Identifier: NCT02124317|
Recruitment Status : Unknown
Verified December 2016 by Dai, Guanghai, Chinese PLA General Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 28, 2014
Last Update Posted : December 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Advanced Pancreatic Cancer||Drug: nanoparticle albumin-bound paclitaxel Drug: S-1||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Nab-paclitaxel Plus S-1 in First-line Treatment of Patients With Advanced Pancreatic Cancer|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||May 2017|
Experimental: nanoparticle albumin-bound paclitaxel, S-1
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycle: 6 cycles.
Drug: nanoparticle albumin-bound paclitaxel
nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Number of cycles: 6 cycles.
S-1 is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycles: 6 cycles.
- Objective response rate [ Time Frame: Measure at every 6 weeks (every 2 cycles) ]Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
- Progression-free survival [ Time Frame: up to 15 months ]Measure of time from study treatment to disease progression or death.
- Overall survival [ Time Frame: up to 2 years ]Measure of time from study treatment to patient's death or lost to follow-up.
- Disease control rate [ Time Frame: Measure every 6 weeks (every 2 cycles) ]The sum of rates of partial response, complete response and steady disease based on Response Evaluation Criteria In Solid Tumors (RECIST).
- Safety and tolerability [ Time Frame: up to 18 month ]Percentage of patients who experience adverse events during this study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02124317
|Chinese PLA General Hospital|
|Beijing, Beijing, China, 100853|
|Principal Investigator:||Guanghai Dai||Chinese PLA General Hospital|