Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
NCT07369791 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76
Last updated 2026-01-28
Summary
A Randomized Phase II Study. To assess the difference in objective response rate (ORR) between adult patients with advanced biliary tract cancer assigned to nivolumab plus relatlimab 360 mg/360 mg in combination with GC or nivolumab plus GC as first-line treatment.
Conditions
- Advanced Biliary Tract Cancer(BTC)
Interventions
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Nivolumab/Relatlimab
Specified dose on specified days
Sponsors & Collaborators
-
Taipei Veterans General Hospital, Taiwan
collaborator OTHER_GOV -
China Medical University Hospital
collaborator OTHER -
Taichung Veterans General Hospital
collaborator OTHER -
Tri-Service General Hospital
collaborator OTHER -
National Cheng-Kung University Hospital
collaborator OTHER -
National Taiwan University Hospital
collaborator OTHER -
Mackay Memorial Hospital
collaborator OTHER -
Kaohsiung Medical University Chung-Ho Memorial Hospital
collaborator OTHER -
National Health Research Institutes, Taiwan
lead OTHER
Principal Investigators
-
Ming-Huang Chen, MD, PhD · Taipei Veterans General Hospital, Taiwan
-
Hui-Jen Tsai, MD, PhD · National Health Research Institutes, Taiwan
-
Chia-Jui Yen, MD, PhD · National Cheng-Kung University Hospital
-
Shiue-Wei Lai, MD, PhD · Tri-Service General Hospital
-
Chiun Hsu, MD, PhD · National Taiwan University Hospital
-
Li-yuan Bai, MD, PhD · China Medical University Hospital
-
Yi-Chang Liu, MD, PhD · Kaohsiung Medical University Chung-Ho Memorial Hospital
-
Nai-Wen Su, MD · Mackay Memorial Hospital
-
Hsin-Chen Lin, MD · Taichung Veterans General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2035-12-31
- Completion
- 2040-12-31
Countries
- Taiwan
Study Locations
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