NCT06383533

Disitamab Vedotin Plus Cadonilimab in Patients With HER2 Mutant Advanced or Metastatic Bile Duct Adenocarcinoma

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Bile Duct Adenocarcinoma Non-Resectable
• HER2 Gene Mutation

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin Plus Cadonilimab	Disitamab Vedotin: 2.0mg/kg，ivgtt，D1, every 2 weeks for a treatment cycle. Cardonilimab: 6mg/kg，ivgtt，D1, every 2 weeks for a treatment cycle.

Timeline

• Start date: 2023-05-01
• Primary completion: 2025-05-01
• Completion: 2025-12-31
• First posted: 2024-04-25
• Last updated: 2024-04-26

Locations

1 site across 1 country: China