NGS as the First-line Treatment in Advanced Biliary Tract Cancer

Status Active, not recruiting

Clinical Trial Summary

To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer

Clinical Trial Description

The primary endpoint will be evaluating overall response rate (ORR) of nivolumab in combination with gemcitabine and TS-1 in patients with advanced BTC. Simon's two-stage design will be used. If there are 3 or fewer subjects with controlled disease in these 19 patients, the study will be stopped. Otherwise, 25 additional patients will be accrued for a total of 44. The null hypothesis will be rejected if 11 or more subjects with controlled disease are observed in 44 patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04172402
Study type	Interventional
Source	National Health Research Institutes, Taiwan
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	December 27, 2019
Completion date	December 31, 2024

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See also
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