CholangiocarcinomaACTICCA-2NCT06175845
Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma
A study testing Intraductal biliary radiofrequency ablation in people with Cholangiocarcinoma and Klatskin Tumor, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholangiocarcinoma, Klatskin Tumor, Bile Duct Cancer
- What is being tested?
- Intraductal biliary radiofrequency ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 9 sitesGermany
- Study dates
- 30 Aug 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)
- Written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 years
- Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
- No prior radiofrequency ablation (RFA) for CCA
- 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)
- 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
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Germany9 sites, 9 recruiting
- Recruiting
Charite
Berlin
- Recruiting
University Medical Center
Bonn
- Recruiting
Clinic Chemnitz
Chemnitz
- Recruiting
University Clinic
Essen
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
- Recruiting
Medical School Hannover
Hanover
- Recruiting
University Clinic
Heidelberg
- Recruiting
UKSH
Lübeck
- Recruiting
Clinic Ulm
Ulm
About this study
Official title: Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma
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:
- Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
- Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).
- Conditions
- Cholangiocarcinoma, Klatskin Tumor, Bile Duct Cancer, Liver Cancer
- Being tested
- Intraductal biliary radiofrequency ablation
- Keywords
- Radiofrequency ablation, Intraductal, Biliary, Endoscopic retrograde cholangiography, Transpapillary, Stent dysfunction, Cholangitis, Obstruction
- Medical subject headings
- Cholangiocarcinoma, Klatskin Tumor, Bile Duct Neoplasms, Liver Neoplasms, Cholangitis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraductal biliary radiofrequency ablationProcedure or surgery
Also called RFA
Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction
| Study group | Role | What they receive |
|---|---|---|
| Arm A: ablation arm | Active comparator | Systemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement. Receives: Procedure: Intraductal biliary radiofrequency ablation |
| Arm B: control arm | No intervention | Systemic chemotherapy and bile duct stenting without RFA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].)
Measured: 6 months
Secondary outcomes (6)
Overall survival
Time to death or last seen alive
Measured: up to 30 month
Satisfaction assessed by EORTC QLQ-C30 questionnaire
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30-item instrument designed to measure quality of life in cancer patients. It is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: 6 months
Satisfaction assessed by EORTC QLQ-BIL21 questionnaire
The EORTC QLQ-BIL21 consists of 21 questions: 3 single-item assessments relating to treatment side effects, difficulties with drainage bags/tubes and concerns regarding weight loss, in addition to 18 items grouped into 5 proposed scales: eating symptoms (4 items), jaundice symptoms (3 items), tiredness (3 items), pain symptoms (4 items) and anxiety symptoms (4 items). The response format is a four-point Likert scale.and designed to more specifically adress side effects.
A high scale score represents a higher response level.
Measured: 6 months
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5
Safety events
Measured: 6 months
Clinical event rate at 6 months
Rate of clinical events defined as per primary outcome after 6 months follow up
Measured: 6 months
Total days of overnight-hospital-stays
Total days of overnight-hospital-stays
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start30 Aug 2024
- Primary completionJul 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johann von Felden, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Johann von Felden, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175845
- Sponsor's protocol ID
- 0645/131
- Acronym
- ACTICCA-2
- Status last verified
- Sep 2026
- First submitted
- 25 Nov 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39090600
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Via Catheter and Transpapillary Access in Patients With Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT06175845
- Acronym / sponsor ID
- ACTICCA-2 / 0645/131
- Conditions
- Cholangiocarcinoma, Klatskin Tumor, Bile Duct Cancer, Liver Cancer
- Keywords
- Radiofrequency ablation, Intraductal, Biliary, Endoscopic retrograde cholangiography, Transpapillary, Stent dysfunction, Cholangitis, Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does radiofrequency ablation of tumorous bile duct occlusion reduce risk of complications in these patients (eg stent dysfunction, delay of chemotherapy, infections etc)?
- Is radiofrequency ablation safe in these patients? All participants will receive standard treatment with systemic chemotherapy and bile duct stenting. Researchers will compare two groups (one group will receive additional radiofrequency ablation, the other not).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: ablation arm | Active comparator | Procedure: Intraductal biliary radiofrequency ablationSystemic chemotherapy and bile duct stenting with intraductal RFA of malignant bile duct obstructions employing a CE-certified ablation catheter prior to stent placement. |
| Arm B: control arm | No intervention | –Systemic chemotherapy and bile duct stenting without RFA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Unresectable perihilar and/or ductal CCA with bile duct stenting and palliative systemic therapy as indicated by the local Multidisciplinary Team (MDT)
- Written informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Age ≥18 years
- Eligibility for palliative systemic therapy based on clinical and laboratory parameters (except hyperbilirubinemia) as determined by the local MDT
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraductal biliary radiofrequency ablationAlso: RFARadiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction | Procedure or surgery | Arm A: ablation arm |
Primary outcome
Time to first event, ie stent dysfunction
Time frame: 6 months
• 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 secondary outcomes
Overall survival
Time frame: up to 30 month
Satisfaction assessed by EORTC QLQ-C30 questionnaire
Time frame: 6 months
Satisfaction assessed by EORTC QLQ-BIL21 questionnaire
Time frame: 6 months
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE V5
Time frame: 6 months
Clinical event rate at 6 months
Time frame: 6 months
Total days of overnight-hospital-stays
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 39090600Schmidt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johann von Felden, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraductal biliary radiofrequency ablation in people with Cholangiocarcinoma and Klatskin Tumor, run by Universitätsklinikum Hamburg-Eppendorf at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+ 49 30 8145344 37, acticca2@aio-studien-ggmbh.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first event, ie stent dysfunction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06175845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.