Dynamic Prediction Model for Patients with Unresectable Biliary Malignancies Receiving Systemic Chemotherapy Combined with Immunotherapy: a Multicenter, Observational Study

This study focused on the longitudinal tumor burden profile (tumor macro features, histopathological types and imaging features, etc.), liver function, health status, tumor biomarkers, and serological indicators of patients with unresectable biliary malignancies before chemotherapy combined with immunotherapy to build a dynamic prediction model. Based on this model, risk stratification of BTC patients was realized to explore which specific populations could safely initiate combination therapy. By constructing a risk stratification model, it can help clinicians to screen the best treatment population and provide a basis for safe treatment of high-risk patients.

NCT Number	NCT06849193
Lead Sponsor	Zhongda Hospital Collaborators: Eastern Hepatobiliary Surgery Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Affiliated Hospital of Soochow University, Jiangsu Cancer Institute & Hospital, The First Affiliated Hospital, University of Science and Technology of China, Zhejiang Cancer Hospital, Shanghai Zhongshan Hospital, Yunnan Cancer Hospital
Conditions	Unresectable Biliary Tract Cancer, Dynamic Prediction Model, Immunotherapy
Enrollment	332 participants
Start Date	2025-01-31
Primary Completion	2026-03-31 (estimated)
Study Completion	2026-05-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-27