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AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer

StatusActive, Not Recruiting
PhasePhase 3
SponsorAkeso
Started2024-10-20
View on ClinicalTrials.gov ↗

Amendment history

2026-01-19
Not Yet Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Active, Not Recruiting
Primary completion date2027-07→2026-10
Start dateestimated 2024-10→confirmed 2024-10-20
Study sitescontacts updated at 2 of 2 sites
2024-09-08
Original filing
Akeso
96 trials monitored
See 1 trial at risk
Cholangiocarcinoma
611 trials monitored
See 25 trials at risk
This is a phase 3 study. All subjects are patients with unresectable locally advanced or metastatic biliary tract cancer (BTC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy versus durvalumab in combination with chemotherapy in patients with unresectable locally advanced or metastatic BTC.
Trial Details
NCT Number NCT06591520
Lead Sponsor Akeso
Conditions Biliary Tract Cancer
Enrollment 682 participants
Start Date 2024-10-20
Primary Completion 2026-10 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-01-21