Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:02 PM
Study NCT ID:
NCT04856761
Status:
RECRUITING
Last Update Posted:
2022-08-18
First Post:
2021-04-22
Brief Title:
A Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
A Phase II Open-Label Study of Capecitabine Versus S-1 as Adjuvant Therapy in Patients With Biliary Tract Carcinoma After Surgical Resection
Status:
RECRUITING
Status Verified Date:
2022-08
Last Known Status:
None
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:
The purpose of this study is to assess the difference of safety and efficacy about Capecitabine and S-1 for treatment of patients with low-risk of recurrence after BTC surgery
Detailed Description:
Patients received curative BTC surgery will be informed about the study After being informed about the study and potential risks all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be observed for recurrence of BTC
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