Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383533
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-22
Brief Title:
Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
An Open-label Single-arm Multicenter Phase II Clinical Study of Disitamab Vedotin Plus Cadonilimab as Therapy in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-04
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:
It is a single arm open-label phase II cinical trial to evaluate the efficacy and safety of Disitamab Vedotin Plus Cadonilimab in second-line treatment of patients with Advanced or Metastatic Bile Duct Adenocarcinoma
Detailed Description:
Biliary tract cancer is a group of highly heterogeneous and aggressive epithelial cancers accounting for about 3 of all digestive system tumors It is highly aggressive and most of them are found in advanced stages with extremely poor prognosis and a 5-year survival rate of less than 5 The overexpression rate of HER2 in biliary tract tumors is about 265 and the amplification rate is about 301 In addition HER2 mutations in biliary tract malignant tumors also include HER2 mutations In addition HER2 mutations in biliary malignant tumors also include HER2 mutations Currently anti-HER2 strategies have become a new hotspot for exploration in BTC It is a single arm open-label phase II cinical trial conducted in China and plans to recruit 28 patients with HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma who have progressed through first-line treatment The purpose of this study is to evaluate the efficacy and safety of second-line treatment with Disitamab Vedotin Plus Cadonilimab
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