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Brief Title: Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma
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
Study ID: NCT06383533
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 26.5%, and the amplification rate is about 30.1%. 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Name: Jieer Ying
Affiliation: Zhejiang Cancer Hospital
Role: PRINCIPAL_INVESTIGATOR