AZD6738 Plus Durvalumab in Biliary Tract Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Bile Duct Cancer
- Chemotherapy Effect
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
This is a single arm, phase II study. Advanced BTC patients who have been previously treated with immunotherapy in either the 2nd or 3rd line will be enrolled. Patients will be treated with AZD6738 and Durvalumab combination. One cycle consists of 4weeks. Response evaluation will be done every 8 wee...
This is a single arm, phase II study. Advanced BTC patients who have been previously treated with immunotherapy in either the 2nd or 3rd line will be enrolled. Patients will be treated with AZD6738 and Durvalumab combination. One cycle consists of 4weeks. Response evaluation will be done every 8 weeks (every 2 cycles) of treatment Tumor biopsy is mandatory: screening, after 8weeks (1st-response evaluation), at disease progression (PD) blood sampling for biomarker study is mandatory: every cycles To evaluate the metabolic changes by AZD6738 and Durvalumab combination : 18 F-FDG PET is mandatory : screening, after 8 weeks (1st-response evaluation)
Tracking Information
- NCT #
- NCT04298008
- Collaborators
- Not Provided
- Investigators
- Not Provided
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