Biliary Tract Neoplasms
Conditions
Interventions
investigational material(s)
Generic name etc : Durvalumab
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mater
Sponsors
Astrazeneca K.K
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. 2. Patients with preciously untreated disease if unresectable or metastatic at initial diagnosis will be eligible. 3. Patient with recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible. 4. WHO/ECOG PS of 0 or 1
Exclusion criteria
Exclusion criteria: 1. History of another primary malignancy 2. Brain metastases or spinal cord compression 3. Uncontrolled intercurrent illness 4. Major surgical procedure within 28 days prior to the study 5. Prior locoregional therapy such as radioembolization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics - | — |
Countries
Argentina, Bulgaria, Chile, China, France, Hong Kong, India, Italy, Poland, Russian Federation, South Korea, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed