NCT05749900View on ClinicalTrials.gov

First-line Trastuzumab, Gemcitabine, Cisplatin and Nivolumab in Advanced HER2- Positive Biliary Tract Cancer: a Multicenter, Open-label, Single-arm Phase Ib/II Trial (HERBOT)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

May 12, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2027

Conditions
HER2 Positive Advanced/Metastatic/Nonresectable Biliary Tract Cancer
Interventions
DRUG

Trastuzumab+Nivolumab+Gemcitabine+Cisplatin

Phase Ib Nivolumab 360mg IV q 3weeks Gemcitabine 1000mg/m2 IV D1, D8 q 3weeks Cisplatin 25mg/m2 IV D1, D8 q 3weeks Trastuzumab 8mg/kg (C1) then 6mg/kg IV q 3weeks Level -1 Nivolumab 360mg IV q 3weeks Gemcitabine 800mg/m2 IV D1, D8 q 3weeks Cisplatin 25mg/m2 IV D1, D8 q 3weeks Trastuzumab 8mg/kg (C1) then 6mg/kg IV q 3weeks

Trial Locations (1)

Unknown

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER