A phase II, multicenter study to investigate the safety and efficacy of atezolizumab monotherapy as a sequential therapy following chemoradiotherapy in patients with locally advanced unresectable esophageal cancer - TENERGY Study

ational Cancer Center Hospital East0 sites50 target enrollmentNovember 1, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 1, 2018

End Date

January 5, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

ational Cancer Center Hospital East

•1\. Active double cancers 2\. Requiring systemic treatment for active infection 3\. Past or concurrent inflammatory bowel disease 4\. Past or concurrent interstitial lung disease 5\. Concurrent autoimmune disease or past chronic or recurrent autoimmune disease 6\. Requiring Systemic treatment with corticosteroids or immunosuppressants or who have received these treatments within 14 days before the enrollment in the study 7\. Past or concurrent thyroid dysfunction 8\. A history or finding of cardiovascular risk 9\. Poorly controlled diabetes mellitus. 10\. Positive for any of the followings: HIV antibody, HBs antigen, HCV antibody test. 11\. Pregnant or lactating 12\. Clinically significant unstable psychiatric disorders or other medical disorders 13\. No prior treatment with atezolizumab, anti\-PD\-1 antibody, anti\-PD\-L1 antibody, anti\-PD\-L2 antibody, anti\-CD137 antibody or anti\-CTLA\-4 antibody, or any other antibody or drug therapy regulating T cell 14\. Not willing to comply or incapable of complying with the procedures specified in the protocol. 15\. Unsuitable for the study due to such as a complicated disorder affecting the assessment of toxicity in the investigator's judgment