NCT06591520Active, not recruitingPhase 3
AK112 Combined With Chemotherapy Versus Durvalumab Combined With Chemotherapy in Advanced Biliary Tract Cancer
A Randomized, Controlled, Multi-center Phase III Study of AK112 Combined With Gemcitabine Plus Cisplatin Versus Durvalumab Combined With Gemcitabine Plus Cisplatin as the First-line Treatment for Patients With Advanced Biliary Tract Cancer
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 682 (actual)
- First submitted
- 8 Sept 2024
- Start date
- 20 Oct 2024
- Primary completion date
- Oct 2026
- Lead sponsor
- Akeso
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06591520
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 682
- From 20 Oct 2024 to the primary completion date, Oct 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has other malignancies within 5 years prior to enrollment.
- Is currently participating in a study of an investigational agent or using an investigational device.
- History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to enrollment.
- Has received a live virus vaccine within 30 days of the planned first dose of study therapy.
- Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
Other illness
- Has an active autoimmune disease that has required systemic treatment in the past 2 years.
- Has an active infection requiring systemic therapy.
- Has known active Hepatitis B or Hepatitis C.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
Other
- Has known active central nervous system (CNS) metastases.
Who the study is looking for
- Be able and willing to provide written informed consent.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has a life expectancy of at least 3 months.
- Has a histologically or cytologically confirmed diagnosis of biliary tract cancer (BTC).
- Has no prior systemic anti-tumor therapy for unresectable locally advanced or metastatic BTC.
- Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Has adequate organ function.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Zhongshan Hospital,Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.