Spots Global Cancer Trial Database for NGS as the First-line Treatment in Advanced Biliary Tract Cancer
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Trial Identification
Brief Title: NGS as the First-line Treatment in Advanced Biliary Tract Cancer
Official Title: A Study of Nivolumab Combination Gemcitabine and S1 as the First-Line Treatment in Patients With Advanced Biliary Tract Cancer
Study ID: NCT04172402
Conditions
Study Description
Brief Summary: To evaluate disease objective response rate (ORR) of nivolumab in combination with gemcitabine and TS1 in patients with advanced biliary tract cancer
Detailed 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.
Eligibility
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
Chang Gung Memorial Hospital, Linkou, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Contact Details
Name: Chen Ming-Huang, MD
Affiliation: Taipei Veterans General Hospital, Taipei, TAIWAN
Role: STUDY_CHAIR
Name: Chiang Nai-Jung, MD
Affiliation: National Health Research Institutes, Taiwan
Role: PRINCIPAL_INVESTIGATOR
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