NCT06849193

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 332 (estimated)
• Sponsor: Zhongda Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unresectable Biliary Tract Cancer
• Dynamic Prediction Model
• Immunotherapy

Interventions

Type	Name	Description
DRUG	Systemic chemotherapy combined with immunotherapy	The electronic medical record system was used to collect patients' basic information and treatment plan information, including treatment plan, administration cycle, administration date, administration dose, frequency, number of cycles, efficacy, adverse reactions, etc.

Timeline

• Start date: 2025-01-31
• Primary completion: 2026-03-31
• Completion: 2026-05-31
• First posted: 2025-02-27
• Last updated: 2025-02-27

Locations

2 sites across 1 country: China