Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-04-14 @ 2:59 AM
Study NCT ID:
NCT02548195
Status:
UNKNOWN
Last Update Posted:
2015-09-14
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxaliplatin+Gemcitabine vs Capecitabine as Adjuvant Therapy for Intrahepatic Cholangiocarcinoma
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Study Overview
Official Title:
Oxaliplatin Plus Gemcitabine Versus Capecitabine Alone as Adjuvant Treatment in the Prevention of Recurrence of Intrahepatic Cholangiocarcinoma
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
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:
To evaluate of adjuvant therapy using oxaliplatin and gemcitabine (GEMOX regimen) versus capecitabine alone chemotherapy in patients who underwent curative surgery for intrahepatic cholangiocarcinoma (ICC) -- a randomized control study.
Detailed Description:
chemotherapy: GEMOX vs capecitabine alone; adjuvant settings; primary endpoint: recurrence-free survival (RFS); second endpoint: overall survival after surgery (OS).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: