NCT05487443

The Efficacy of Chemotherapy Combined With Immunocheckpoint Inhibitors in Advanced Biliary Malignancies

An Open, Single-arm Prospective Clinical Study Evaluating the Efficacy of Systemic Venous Gemcitabine-based Chemotherapy Combined With Immunocheckpoint Inhibitors in First-line Treatment of Advanced Biliary Malignancies

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To the patient of terminal biliary malignancy tumor, how should the patient's treatment plan choose ? To address this problem, this study intends to analyze systemic venous gemcitabine-based chemotherapy regimen combined with immune checkpoint inhibitors in patients with advanced BTC, to evaluate the long-term efficacy and toxicity of patients, and to search for predictable biomarkers. In order to clarify the advantages and disadvantages of intravenous chemotherapy combined with immunotherapy for patients with advanced biliary malignancy, provide certain basis for clinical work, and then select the most suitable treatment plan for patients according to the different characteristics of individual patients.

Conditions

• Gemcitabine
• Biliary Tract Cancer
• Immune Checkpoint Inhibitors

Interventions

Type	Name	Description
DRUG	Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors	Gemcitabine-based chemotherapy regimen combined with immunocheckpoint inhibitors for first-line treatment of advanced biliary malignancies

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-09-30
• Completion: 2024-08-30
• First posted: 2022-08-04
• Last updated: 2022-08-04

Locations

1 site across 1 country: China