ivosidenib maintenance after SOC adjuvant chemotherapy in curative mIDH1 cholangiocarcinoma
Conditions
Brief summary
1-year recurrence-free survival rate (RFS@1year), defined as proportion of patients alive with no disease recurrence 1 year after start of maintenance ivosidenib
Detailed description
RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause, Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence, Time to treatment failure (TTF), defined as time from start of ivosidenib maintenance to the date of premature treatment discontinuation from any cause, including disease recurrence, treatment toxicity or death, Overall survival (OS), defined as time from enrollment to the date of death from any cause, Safety, Quality of life using EORTC QLQ-C30 and EORTC QLQ-BIL21 questionnaires
Interventions
Sponsors
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year recurrence-free survival rate (RFS@1year), defined as proportion of patients alive with no disease recurrence 1 year after start of maintenance ivosidenib | — |
Secondary
| Measure | Time frame |
|---|---|
| RFS, defined as time from start of ivosidenib maintenance to the date of disease recurrence or death to any cause, Time to recurrence (TTR), defined as time from start of ivosidenib maintenance to the date of disease recurrence, Time to treatment failure (TTF), defined as time from start of ivosidenib maintenance to the date of premature treatment discontinuation from any cause, including disease recurrence, treatment toxicity or death, Overall survival (OS), defined as time from enrollment to the date of death from any cause, Safety, Quality of life using EORTC QLQ-C30 and EORTC QLQ-BIL21 questionnaires | — |
Countries
Germany
Outcome results
None listed