Letzte Aktualisierung: 06.05.2026
Gallengangskarzinom [C24]
ACTICCA-2
Studieninformationen
Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial)
Ziele
Primäres Prüfziel
The primary endpoint is time-to-first event (during 6 months follow up), i.e. stent dysfunction defined by bilirubin >5 mg/dl and/or cholangitis (fever >38.5°C and/or increase in C-reactive protein by at least 3-fold upper limit of normal and at least 20% from baseline without extrahepatic focus and absence of tumor progression) leading to premature stent replacement and/or disruption of chemotherapy (all possible events will be reviewed by a blinded and independent ERC.)
Sekundäre Prüfziele für die Behandlungsarme:
The secondary endpoints will include: QoL Clinical event rate @ 6 months OS Total days of over-night-hospital-stays during the trial period Safety (terminology and grading according to NCI CTCAE v5)
Design
Design
Phase
Zentren
Datenerhebung
Interventionsgruppen
Verblindung
Erkrankung
Diagnose
Diagnosenbeschreibung
cholangiozelluläres Karzinom
Mutation
Patienten
Alter
Einschlusskriterien
1. Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT) 2. Written informed consent 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Age ≥18 years 5. Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT 6. No prior radiofrequency ablation (RFA) for CCA 7. No repeated bile duct stenting in the past 3 months (trial inclusion is possible upon first stent replacement or initial stent placement within past 3 months) 8. No concomitant disease or malignancy interfering with the study procedure or efficacy outcome measures, particularly no severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, myocardial infarction within ≤3 months, significant arrhythmias) and no psychiatric disorders precluding understanding of information of trial related topics and giving informed consent
Ausschlusskriterien
Inclusion and exclusion criteria are based on the main selection criteria for patients with unresectable perihilar and/or ductal CCA who are recommended to receive bile duct stenting and palliative systemic therapy by current guidelines
Therapie
Intervention
Substanz
| Prüfplancode | D781PC00001 |
|---|---|
| EudraCT | - |
| Clinicaltrials.gov | 06175845 |
|---|---|
| ISRCTN | - |
| DRKS | - |
Zuständige Gesamtstudie
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Leiter der klinischen Prüfung (LKP)—
Studiengruppen/-zentrale
Kontakt Klinische Studien
CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490
CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036
CIO Köln: Uniklinik Köln, +49 (0) 221 478-0
CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)




