NCT06175845|RecruitingDMC
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma
ACTICCA-2
Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma
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Sponsor study identifier
interventional
130
1 country
9
Study Start
August 30, 2024
Actual (reported)Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to learn about radiofrequency ablation in patients with unresectable bile duct cancer who receive systemic chemotherapy and bile duct stenting. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2023
Actual (reported)December 19, 2023
Actual (reported)August 30, 2024
Actual (reported)July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Time to first event, ie stent dysfunction
• 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 Endpoint Review Committee \[ERC\].)
6 months
Overall survival
up to 30 month
Satisfaction assessed by EORTC QLQ-C30 questionnaire
6 months
Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement.
Systemic chemotherapy and bile duct stenting without RFA.
Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Charite
Berlin, Germany
University Medical Center
Bonn, Germany
Clinic Chemnitz
Chemnitz, Germany
University Clinic
Essen, Germany
Schmidt C, Zapf A, Ozga AK, Canbay A, Denzer U, De Toni EN, Lohse AW, Schulze K, Rosch T, Stein A, Wege H, von Felden J. Radiofrequency ablation via catheter and transpapillary access in patients with cholangiocarcinoma (ACTICCA-2 trial) - a multicenter, randomized, controlled, open-label investigator-initiated trial. BMC Cancer. 2024 Aug 1;24(1):931. doi: 10.1186/s12885-024-12693-w.
Johann von Felden, MD
Universitätsklinikum Hamburg-Eppendorf
First Submitted
November 25, 2023
First Posted
December 19, 2023
Study Start
August 30, 2024
Actual (reported)Primary Completion
July 2027
EstimatedSatisfaction assessed by EORTC QLQ-BIL21 questionnaire
6 months
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5
6 months
Clinical event rate at 6 months
6 months
Contact the study team to confirm eligibility.
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Medical School Hannover
Hanover, Germany
University Clinic
Heidelberg, Germany
UKSH
Lübeck, Germany
Clinic Ulm
Ulm, Germany
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
November 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 9, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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