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Cadonilimab plus Regorafenib and Gem-Cis in advanced biliary tract cancer
NCT05820906Phase 2
Key facts
- Status
- Unknown
- Start
- Sep 2023
- Primary completion
- Sep 2024
- Countries
- 1
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Modality
- Bispecific Antibodies
- Drugs
- cadonilimab
- Conditions
- biliary tract cancer (BTC)
01
Overview
Phase 2, open-label, single-arm trial of cadonilimab in biliary tract cancer (BTC), sponsored by Tianjin Medical University Cancer Institute and Hospital. Primary endpoint: Overall Response Rate at 1 year. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Cadonilimab+rego+Gem/Cis
Cadonilimab 10mg/kg IV Q3W + Regorafenib 80mg PO QD + Gemcitabine 1000mg/m2 IV D1,D8 Q3W + Cisplatin 25mg/m2 IV D1,D8 Q3W
03
Who it enrols
Patients with histologically confirmed advanced biliary tract cancer, no prior systemic treatment, ECOG 0-1, and Child-Pugh A liver function.
04
Endpoints
Primary
Overall Response Rate
Secondary
Overall Survival
Progression-Free Survival
Adverse Events
Disease Control Rate
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