NIPH Clinical Trials Search

General Drug Use-Results Survey of Tibsovo(biliary tract cancer)

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	IDH1 mutated biliary tract cancer
Date of first enrollment	01/07/2026
Target sample size	144
Countries of recruitment
Study type	Observational
Intervention(s)

Outcome(s)

Primary Outcome

<Safety Evaluation Items> -Incidence of Guillain-Barre syndrome as AE and ADR

Secondary Outcome

<Safety Evaluation Items> -Incidence of the other AEs and ADRs -Descriptive statistics of seriousness, severity and timing of onset for AEs and ADRs including Guillain-Barre syndrome -Estimation of factors that are likely to affect safety based on patient characteristics and others -Incidence of AEs and ADRs in patients with specific backgrounds <Efficacy-related items> -Tumor response assessment (CR/PR/SD/PD/NE) -Overall response rate (ORR) and disease control rate (DCR) -Analysis of each patient background factor and other factors that are likely to affect efficacy -Overall survival (OS)

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with IDH1 mutated nonresectable biliary tract cancer progressed after cancer chemotherapy who receive the first dose of TIBSOVO during this survey period and who agree to participate in the survey
Exclude criteria	Has a history of hypersensitivity to any of the ingredients of TIBSOVO