Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors

Biliary Tract Tumor Clinical Trial

Official title: A Single-arm, Open-label Clinical Study of Combined Therapy of Tisleizumab , Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors

Status Recruiting

Clinical Trial Summary

This study is a single-center, single-arm, open-label clinical study. All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab, lenvatinib and XELOX regimen (oxaliplatin plus capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. Patients will be closely monitored for safety and tolerability throughout the study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Biliary Tract Tumor

• NCT number: NCT05291052
• Study type: Interventional
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Yongxiang Xia, Doctor
• Phone: 86-025-68303211
• Email: yx_xia@njmu.edu.cn
• Status: Recruiting
• Phase: Phase 2
• Start date: February 14, 2022
• Completion date: March 30, 2024