NCT06074029

Exploratory Study on the Therapeutic Effect Prediction Model of Advanced BTC Immunotherapy

Exploratory Study on the Therapeutic Effect Prediction Model of Immune Checkpoint Inhibitors for Advanced Biliary Tract Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

1. Establish a predictive model for the efficacy of immune checkpoint inhibitors (ICI) in Chinese patients with biliary tract cancers. By analyzing the dynamic changes of circulating tumor DNA (ctDNA) and other clinical and pathological features before and after ICI treatment in a cohort of patients with biliary tract tumors, a predictive model can be established to evaluate the efficacy of ICI treatment in the early stages or even before treatment, serving as a reliable tool for selecting patients who are likely to benefit from ICI treatment. 2. Investigate the clinical features of populations that benefit from different immune combination therapies. By comparing the differences and enrichment of mutations between patients receiving different treatment regimens, and if patients have sufficient pre-treatment tissue, further comparisons of differentially expressed genes and pathways may be made.

Conditions

• Biliary Tract Cancer
• Immune Checkpoint Inhibitor
• Predictive Cancer Model

Interventions

Type	Name	Description
DRUG	Immune Checkpoint Inhibitors	Immune Checkpoint Inhibitors including Durvalumab, Pembrolizumab and Toripalimab

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-30
• Completion: 2024-08-01
• First posted: 2023-10-10
• Last updated: 2024-02-08

Locations

1 site across 1 country: China