NCT06092645

Surufatinib Plus Cadonilimab in Patients With Unresectable or Metastatic Bile Duct Adenocarcinoma

An Open-label, Single-arm, Multicenter, Phase II Clinical Study of Surufatinib Plus Cadonilimab as Second-line Therapy in Patients With Unresectable or Metastatic Bile Duct Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm, multicenter Phase II clinical study to evaluate the efficacy and safety of surufatinib combined with cardanilimab in second-line treatment of patients with inoperable or metastatic bile duct adenocarcinoma

Detailed description

This is an open-label, single-arm, multicenter Phase II clinical trial. It is planned to enroll patients with inoperable or metastatic bile duct adenocarcinoma who have progressed through first-line chemotherapy combined with immunotherapy in several hospitals across the country to evaluate the efficacy and safety of second-line treatment with surufatinib Combination With Cadonilimab.

Conditions

• Bile Duct Adenocarcinoma

Interventions

Type	Name	Description
DRUG	surufatinib plus cadonilimab	Surufatinib: 250mg , po,qd, d1-d21, every 3 weeks for a treatment cycle. Cadonilimab: 10mg/kg, iv, d1, every 3 weeks for a treatment cycle

Timeline

• Start date: 2023-10-30
• Primary completion: 2024-10-01
• Completion: 2025-10-31
• First posted: 2023-10-23
• Last updated: 2023-10-23

Locations

1 site across 1 country: China