Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607276
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
Adebrelimab Combined With Capecitabine for Adjuvant Therapy in Cholangiocarcinoma With High-risk Recurrence Post-surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Controlled Phase II Study of Adjuvant Therapy With Atezolizumab Combined With Capecitabine for Cholangiocarcinoma With High-risk Recurrence Post-surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACAC
Brief Summary:
Biliary tract malignancies BTC are malignant tumors that originate from the epithelium of the bile ducts Currently the optimal treatment for biliary tract malignancies is radical surgical resection In recent years with the advancement of imaging technology and surgical techniques there has been certain progress in the diagnosis and treatment of biliary tract malignancies However the surgical resection rate and long-term survival rate after surgery are still not satisfactory and the high postoperative recurrence rate is an important factor affecting the long-term survival of patients Therefore there is an urgent need to explore new postoperative adjuvant treatment plans to reduce postoperative tumor recurrence which is of great significance for extending the survival of patients with biliary tract malignancies In the NCCN and CSCO guidelines capecitabine is listed as a category I recommendation for adjuvant treatment of biliary tract malignancies BTC However in clinical practice the use of capecitabine or tegafur for postoperative patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate Therefore there is still a huge unmet need in the clinical adjuvant treatment after surgery for biliary tract malignancies Based on the above background we plan to carry out a randomized open and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma
Detailed Description:
Postoperative adjuvant therapy for biliary system tumors has long lacked a universally recognized standard regimen The BILCAP trial results showed a survival benefit with adjuvant therapy The BILCAP study filled the gap in the field of postoperative adjuvant therapy for biliary system tumors In the study the median overall survival OS in the capecitabine group was 511 months compared to 364 months in the observation group The median recurrence-free survival RFS in the capecitabine group was 244 months compared to 175 months in the observation group Compared to the observation group adjuvant therapy with capecitabine significantly prolonged both OS and RFS and the capecitabine group had good tolerability with no chemotherapy-related deaths In addition the ASCOT study reported that adjuvant therapy with tegafur after surgery could prolong the RFS rate in patients Therefore in the NCCN and CSCO guidelines capecitabine is listed as a category I recommendation for adjuvant therapy of biliary tract malignancies BTC However it is regrettable that the latest reports show that in the intention-to-treat ITT population the BILCAP trial failed to reach its primary endpoint of OS with the median OS in the study group and the control group being 511 months and 364 months respectively HR081 95 CI063104 P0097 Furthermore in clinical practice the use of capecitabine or tegafur after surgery in patients with cholangiocarcinoma at high risk of recurrence still has a high recurrence rate Therefore there is still a significant unmet need in the clinical postoperative adjuvant therapy for biliary tract malignanciesBased on the above background we plan to carry out a randomized open and comparative study to observe the efficacy and safety of Adebrelimab combined with capecitabine for adjuvant treatment in patients with biliary tract malignancies after surgery and to explore treatment methods to improve the efficacy of postoperative adjuvant treatment for cholangiocarcinoma
Study Oversight
Has Oversight DMC:
None
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?:
None