Letzte Aktualisierung: 06.05.2026

Gallengangskarzinom [C24]

ACTICCA-2

Aktive Studien

Studieninformationen

Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial)

Behandlungszentren im CIO

Bonn


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

Nicht zutreffend

Zentren

Datenerhebung

Interventionsgruppen

Verblindung

Erkrankung

Diagnose

Gallengangskarzinom [C24], Gallenwege innerhalb der Leber (intrahepatisch) [C22.1]

Diagnosenbeschreibung

cholangiozelluläres Karzinom

Mutation

Patienten

Alter

18+ Jahre

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

Zuständige Gesamtstudie

Sponsor

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)