Endoscopic Radiofrequency Ablation for Unresectable Cholangiocarcinoma

NCT06175845 | Not Yet Recruiting DMC

• 1 other identifier: 0645/131
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Radiofrequency ablation; Intraductal; Biliary; Endoscopic retrograde cholangiography; Transpapillary; Stent dysfunction; Cholangitis; Obstruction

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Overall survival

  up to 30 month

• Satisfaction assessed by EORTC QLQ-C30 questionnaire

  6 months

• Satisfaction 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

Study Arms (2)

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.

Procedure: Intraductal biliary radiofrequency ablation

Arm B: control arm

NO INTERVENTION

Systemic chemotherapy and bile duct stenting without RFA.

Interventions

Intraductal biliary radiofrequency ablation PROCEDURE

Radiofrequency ablation via catheter and transpapillary access of malignant bile duct obstruction

Also known as: RFA

Arm A: ablation arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Location

Related Publications (1)

• 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.

  PMID: 39090600 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma; Klatskin Tumor; Bile Duct Neoplasms; Liver Neoplasms; Cholangitis; Bites and Stings

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Johann von Felden, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 19, 2023
• Study Start: February 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

DE (1)