An observational study in Cholangiocarcinoma, sponsored by iOMEDICO AG. Recruiting at 19 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by iOMEDICO AG · Observational
Cholangiocarcinoma is a rare and aggressive tumor of the bile duct associated with a poor prognosis and very limited treatment options. The IDH1 inhibitor ivosidenib provides a new, targeted treatment option for this disease. Ivosidenib was approved by European Medicines Agency (EMA) in May 2023 as monotherapy in adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
The prospective, multicenter, observational study IDHIRA will collect first real-world data on ivosidenib treatment in a broad patient population in Germany. Ivosidenib will be administered according to the current SmPC. Thus, IDHIRA will generate real-world evidence on effectiveness, quality of life (QoL) and safety of ivosidenib.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
This study's planned enrollment of 100 is below the median of 196 across 161 observational studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →iOMEDICO AG is the lead sponsor of 53 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with IDH1 R132-mutated locally advanced or metastatic CCC who have received at least one prior line of systemic therapy and who have already been scheduled by their treating physician to receive ivosidenib prior to enrolment in IDHIRA are eligible to participate.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For patients participating in the PRO module (optional):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Progression-free survival (PFS)
PFS is defined as the time interval measured from the day of first ivosidenib administration to first progression or death, whichever comes first. Patients without tumor progression or death at the time of analysis will be censored at their date of last contact.
Time frame: max. 38 months (FPI - LPLV)
Overall survival (OS)
OS is defined as the time interval measured from the day of first ivosidenib administration to time of death from any cause. Time to last contact will be used if a patient has no documented date of death and OS for the patient will be considered censored.
Time frame: max. 38 months (FPI - LPLV)
Timt to treatment failure (TTF)
TTF is defined as the time interval measured from the day of first ivosidenib until discontinuation of treatment for any reason including progression, toxicity, start of a new antineoplastic therapy, or death, whichever occurs first. Patients dropping out without knowledge of a potential ending of therapy (e.g., lost to follow up) will be censored with the last date of contact.
Time frame: max. 38 months (FPI - LPLV)
Overall response rate (ORR)
ORR is defined as the proportion of patients achieving a complete or partial response as best response. Patients without response measurement are considered non-responders.
Time frame: max. 38 months (FPI - LPLV)
Disease control rate (DCR)
DCR is defined as the proportion of patients achieving complete response, partial response, or stable disease as best response. Patients without response measurement are considered non-responders.
Time frame: max. 38 months (FPI - LPLV)
(Serious) adverse events ((S)AE))
The case- and patient-based incidence of (S)AEs will be provided.
Time frame: max. 38 months (FPI - LPLV)
(Serious) adverse drug reactions ((S)ADR) related to ivosidenib
The case- and patient-based incidence of (S)ADRs will be provided.
Time frame: max. 38 months (FPI - LPLV)
Adverse events of special interest (AESI)
The case- and patient-based incidence of AESIs will be provided.
Time frame: max. 38 months (FPI - LPLV)
Global health-related quality of life during course of treatment
The change from baseline (i.e., difference) in the scales of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer quality of life questionnaire C30) will be displayed for each point in time, using boxplots. The scales of the EORTC QLQ-C30 range in score from 0 to 100. A high scale score represents a higher response level.
Time frame: max. 38 months (FPI - LPLV)
Cholangiocarcinoma-related quality of life during course of treatment
The change from baseline (i.e., difference) in the scales of the EORTC QLQ-BIL21 (European Organisation for Research and Treatment of Cancer quality of life questionnaire BIL21) will be displayed for each point in time, using boxplots. The scales of the EORTC QLQ-BIL21 range in score from 0 to 100. A high scale score represents a higher response level.
Time frame: max. 38 months (FPI - LPLV)
Assessing parameters of physician treatment decision making
Frequencies of distinct impact ratings for parameters affecting ivosidenib therapy choice will be visualized using stacked bar charts.
Time frame: max. 30 months (recruitment period)
Assessing parameters of physician treatment satisfaction
Frequencies of distinct satisfaction levels with ivosidenib treatment effectiveness and AE management will be visualized using stacked bar charts.
Time frame: max. 32 months (recruitment period plus 8 weeks)
Cumulative ivosidenib dose
Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.
Time frame: max. 38 months (FPI - LPLV)
Absolute dose intensity of ivosidenib
Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.
Time frame: max. 38 months (FPI - LPLV)
Relative dose intensity of ivosidenib
Summary tables containing descriptive statistics (n, mean, standard deviation, median, 25th and 75th percentiles, minimum, and maximum) will be provided.
Time frame: max. 38 months (FPI - LPLV)
Frequency of dose modifications
Frequency of dose modifications will be presented.
Time frame: max. 38 months (FPI - LPLV)
Type of dose modifications
Type of dose modifications (i.e., dose reductions, dose escalations, and interruptions) will be presented.
Time frame: max. 38 months (FPI - LPLV)
Reasons for dose modifications
Reasons for dose modifications will be presented.
Time frame: max. 38 months (FPI - LPLV)
Duration of treatment with ivosidenib
Duration of treatment with ivosidenib
Time frame: max. 38 months (FPI - LPLV)
Reasons for end of treatment (EOT)
Reasons for end of treatment will be displayed
Time frame: max. 38 months (FPI - LPLV)
Type of last previous therapy
Type of substances given in the last previous therapy will be displayed.
Time frame: max. 38 months (FPI - LPLV)
Frequency of last previous therapy
Frequency of different substances given in the last previous therapy will be displayed.
Time frame: max. 38 months (FPI - LPLV)
Duration of last previous therapy line
Duration of last previous therapy line will be displayed.
Time frame: max. 38 months (FPI - LPLV)
Concomitant medications
Frequency of concomitant medications in total will be displayed.
Time frame: max. 38 months (FPI - LPLV)
Concomitant medications known to induce QT prolongation
Frequency of concomitant medications known to induce QT prolongation (e.g., antiarrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) will be displayed.
Time frame: max. 38 months (FPI - LPLV)
Subsequent antineoplastic therapies
Frequency and type of subsequent antineoplastic therapies by line of therapy will be displayed.
Time frame: max. 38 months (FPI - LPLV)
Started Oct 2024 (actual). Primary completion is estimated for Dec 2027, 38 months after the start.
Of 70 observational studies under Cholangiocarcinoma, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 33. This study's planned 38 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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