Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT04856761
Status:
UNKNOWN
Last Update Posted:
2022-08-18
First Post:
2021-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
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:
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:
UNKNOWN
Status Verified Date:
2022-08
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:
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:
False
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?: