Biliary Tract Cancer
Conditions
Interventions
Drug: Gemcitabine
Drug: Cisplatin
Drug: Durvalumab
Drug: Rilvegostomig
Sponsors
Hibi Kazushige
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC). - Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting - Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample. - Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements. - ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization. - Adequate bone marrow and organ function.
Exclusion criteria
Exclusion criteria: - Ampullary carcinoma - Any prior systemic therapy received for unresectable, locally advanced or metastatic BTC. - Any prior exposure to any other therapy targeting immune-regulatory receptors or mechanisms. - Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study. - Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment. - Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Overall Survival (OS) in the PDL1 >_ 1% population [Time Frame: approximately 4 years] _Overall Survival is defined as time from randomization until the date of death due to any | — |
Countries
Australia, Belium, Brazil, Canada, China, Germany, India, Italia, Japan, Netherlands, South Korea, Spain, Taiwan, Thailand, United States
Contacts
Public ContactKazushige Hibi
Astrazeneka K.K
Outcome results
None listed