Clinical Trials Directory

Trials / Unknown

UnknownNCT05056116

A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer

A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer : a Phase Ⅱ Study

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
The Affiliated Hospital of Xuzhou Medical University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

Summary

A Phase Ⅱ, open-label, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer.

Detailed description

A Phase 2, open-label, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer (intrahepatic or extrahepatic cholangiocarcinoma, gallbladder cancer).

Conditions

Interventions

TypeNameDescription
DRUGSurufatinib ToripalimabSurufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Toripalimab injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.

Timeline

Start date
2021-09-01
Primary completion
2022-06-01
Completion
2024-06-01
First posted
2021-09-24
Last updated
2021-12-27

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05056116. Inclusion in this directory is not an endorsement.