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

  • End date
    Mar 30, 2024
  • participants needed
  • sponsor
    The First Affiliated Hospital with Nanjing Medical University
Updated on 5 April 2022


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.

Condition Biliary Tract Tumor
Treatment Capecitabine, Oxaliplatin, Lenvatinib, tislelizumab
Clinical Study IdentifierNCT05291052
SponsorThe First Affiliated Hospital with Nanjing Medical University
Last Modified on5 April 2022


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