Ignite Creation Date:
2024-05-06 @ 12:39 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03815461
Status:
UNKNOWN
Last Update Posted:
2019-01-25
First Post:
2019-01-23
Brief Title:
Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Sponsor:
Chinese Academy of Medical Sciences
Organization:
ChineseAMS
Study Overview
Official Title:
Phase II Clinical Study of Nab-paclitaxel Combined With S-1 as Induction Therapy for Locally Advanced Pancreatic Cancer
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This single-arm Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable
Detailed Description:
This single-arm Phase II clinical trial is to evaluate the efficacy and safety of nab-paclitaxel plus S-1 in locally advanced pancreatic cancer who were borderline resectable or unresectable Nab-paclitaxel was administered at 125mgm2 intravenously on day 1 and 8 S-1 80 100 or 120 mgd according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles
During the study if the subjects weight change was 10 from baseline the dose was calculated based on the measured value at baseline If the change was 10 the body surface area of the subject should be recalculated and the dose administered should be adjusted
Study treatment period Borderline resectable According to the results of imaging examination MDT discussed to determine the surgical resectability and timing of surgery The chemotherapy time was 4-6 cycles
Unresectable Chemotherapy for up to 6 cycles According to the results of imaging examination MDT determined the resectability of the operation It was decided by the investigator and the patient to continue chemotherapy S-1 maintenance surgery or radiotherapy
During the study if the subjects weight change was 10 from baseline the dose was calculated based on the measured value at baseline If the change was 10 the body surface area of the subject should be recalculated and the dose administered should be adjusted
Study treatment period Borderline resectable According to the results of imaging examination MDT discussed to determine the surgical resectability and timing of surgery The chemotherapy time was 4-6 cycles
Unresectable Chemotherapy for up to 6 cycles According to the results of imaging examination MDT determined the resectability of the operation It was decided by the investigator and the patient to continue chemotherapy S-1 maintenance surgery or radiotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None