NCT04298008 AZD6738 Plus Durvalumab in Biliary Tract Cancer
| NCT ID | NCT04298008 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Seoul National University Hospital |
| Condition | Bile Duct Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 26 participants |
| Start Date | 2020-06-25 |
| Primary Completion | 2024-12-31 |
Trial Parameters
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Brief Summary
This trial will enroll advanced biliary tract cancer patients who have been previously treated with immunotherapy in either the 2nd or 3rd line. Patients will be treated with AZD6738 and Durvalumab combination.
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent and any locally-required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age \> 20 years at time of study entry 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 4. Life expectancy of \> 16weeks 5. Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer 6. Unresectable or recurrent 7. Failed immunotherapy for their advanced BTC (the patient may have also received chemotherapy in the 1 or 2L) 8. At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging \[MRI\] where CT is contraindicated) and is suitable for repeated assessment as per RECIST 1.1. 9. Body weight \>30kg 10. Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment
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