First-line patients with advanced biliary tract cancers (BTC) MedDRA version: 27.0 Level: PT Classification code 10008593 Term: Cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion 1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma. 2. Previously untreated disease if unresectable or metastatic at initial diagnosis 3. Recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) 4. WHO/ECOG PS of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 405 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 405
Exclusion criteria
Exclusion criteria: Exclusion 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 |
|---|---|
| Main Objective: To assess the efficacy of Arm A compared to Arm B in terms of OS in patients with first-line advanced BTC;Secondary Objective: To further assess the efficacy of Arm A compared to Arm B in terms of Progression-free survival (PFS), ORR (Objective response rate) , and Duration of response (DoR) in patients with first-line advanced BTC using Investigator assessments To summarize the efficacy of Arm A compared to Arm B in terms of ORR and DoR in patients with first-line advanced BTC using BICR assessments To assess disease-related symptoms, impacts, and HRQoL in patients treated with Arm A compared to Arm B To assess the efficacy of Arm A compared to Arm B by PD-L1 expression To assess the PK of durvalumab when used in combination with gemcitabine/cisplatin To investigate the immunogenicity of durvalumab;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Assessments for Overall survival will be collected regularly at predefined time points until death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Progression-free survival (PFS), ORR (Objective response rate) , and Duration of response (DoR) according to RECIST 1.1using Investigator assessments ORR and DoR according to RECIST 1.1 using BICR assessments EORTC QLQ-C30: Global health status/QoL and impacts (eg, physical function); multi-term symptoms (eg, fatigue); and single items (eg, appetite loss, insomnia). EORTC QLQ-BIL21: Single-item symptoms (eg, abdominal pain [item 42], pruritus [item 36], jaundice [item 35]) Association of PD-L1 expression level with PFS, ORR, DoR, and DCR (Disease control rate) according to RECIST 1.1 using Investigator assessments and OS (Overall survival) Serum concentration of durvalumab (peak and trough concentrations) Presence of ADAs for durvalumab (confirmatory results: positive or negative);Timepoint(s) of evaluation of this end point: Assessments will be made regularly until progressive disease or until the end of the study | — |
Countries
Argentina, Bulgaria, Chile, China, France, Hong Kong, India, Italy, Japan, Korea, Republic of, Poland, Russian Federation, Taiwan, Thailand, Türkiye, United Kingdom, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed