Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490107
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
Durvalumab Combined With S-1 as Adjuvant Therapy of Resectable BTC
Sponsor:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Organization:
Cancer Institute and Hospital Chinese Academy of Medical Sciences
Study Overview
Official Title:
A Single-arm Single-center Study of Durvalumab Combined With S-1 as Adjuvant Therapy for Resectable Biliary Tract CancerBTC With High Risk of Recurrence
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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 aim of this study is to assess the efficacy and safety of durvalumab combined with S-1 as adjuvant therapy of resectable Biliary Tract CancerBTC with high risk of recurrence
Detailed Description:
Radical surgical resection is still the most important radical treatment for biliary tract tumors and the postoperative recurrence rate of BTC patients remains high It is particularly important to choose appropriate and effective adjuvant treatment
This study is a single center single arm prospective phase II clinical study This study plans to include 40 BTC patients after radical resection The patients are evaluated by a multidisciplinary team MDT as high risk of recurrence Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1 with a 21-day dosing cycle After 8 cycles of adjuvant therapy if the patients do not experience disease recurrence or intolerancethen the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle
If the patients experience recurrence the subsequent treatment plan will be determined by the researchers based on treatment guidelines
This study is a single center single arm prospective phase II clinical study This study plans to include 40 BTC patients after radical resection The patients are evaluated by a multidisciplinary team MDT as high risk of recurrence Adjuvant therapy with durvalumab combined with S-1 should be started no more than 12 weeks after radical surgery These patients will first receive 8 cycles of adjuvant therapy and the regimens consist of durvalumab and S-1 with a 21-day dosing cycle After 8 cycles of adjuvant therapy if the patients do not experience disease recurrence or intolerancethen the patients wil receive 6 cycles of adjuvant therapy in maintenance therapy stage The regimen of andjuvant therapy is durvalumab with 28-day dosing cycle
If the patients experience recurrence the subsequent treatment plan will be determined by the researchers based on treatment guidelines
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