protocolSection identificationModule nctId: NCT06274879, orgStudyIdInfo id: 1938 Ablatio-bilica, secondaryIdInfos id: SNCPT, type: OTHER, domain: Portal for clinical trials in Switzerland, briefTitle: Safety of Biliary Intraductal Radiofrequency Ablation in Patients With Unresectable Extrahepatic Biliary Tract Cancer, acronym: Ablatio, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-04-30, completionDateStruct date: 2026-04-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Insel Gruppe AG, University Hospital Bern, class: OTHER, collaborators name: Swiss Cancer League, descriptionModule briefSummary: The goal of this clinical trial is to provide evidence for the general tolerability of radiofrequency ablation (bRFA) in patients with unresectable bile duct cancer undergoing systemic palliative treatment consisting of chemotherapy (gemcitabine and cisplatin) plus durvalumab (immune-checkpoint-inhibitor, ICI). The main question it aims to answer is whether it is safe to combine chemotherapy (gemcitabine and cisplatin) and immunotherapy (durvalumab) - CICI therapy.Participants will be assigned to either the control group or the experimental group. In the control group, the standard of care consists of endoscopy with stent placement in the bile duct and CICI, whereas in the experimental group, bRFA will be performed in addition to the standard of care. Participants will be followed up for 6 months, during the follow-up, the stage of the tumor, blood examination, the duration of the stent from the insertion until its failure, adverse events and quality of life will be examined.Researchers will compare the standard of care alone to the experimental group to see if the additional bRFA procedure causes higher or no difference in adverse events rate., conditionsModule conditions: Bile Duct Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: Gemcitabin, Cisplatin and Durvalumab, interventions name: Biliary Radiofrequency Ablation, interventions name: Endoscopic Retrograde Cholangio-Pancreatography with stenting, outcomesModule primaryOutcomes measure: Any grade 3 or 4 adverse events (AE) leading to chemo-immune checkpoint inhibitor-therapy (CICI) discontinuation up to six months after enrolment., secondaryOutcomes measure: Endoscopic complications as measured by the Adverse events GastRointestEstinal Endoscopy (AGREE) criteria specifically developed for endoscopic interventions, secondaryOutcomes measure: Progression-free survival, which is defined as the time till the progression of disease or death, whatever comes first, from the time of enrolment to the end of follow-up., secondaryOutcomes measure: Death from any cause from the time of enrolment to the end of follow-up (overall survival)., secondaryOutcomes measure: Development of disease-specific quality-of-life as measured by the EORTC QLQ-BIL21 before every CICI cycle plus at 3 and 6 months from the start of the CICI treatment, secondaryOutcomes measure: Change in health-related quality-of-life at baseline, 3 and 6 months from the start of the CICI treatment as measured by the EORTC QLQ-C30, secondaryOutcomes measure: Stent patency at month 3 visit and end of study visit, secondaryOutcomes measure: Number of courses of CICI applied, secondaryOutcomes measure: Total dose of CICI applied, otherOutcomes measure: Details of adverse events, otherOutcomes measure: Prognostic significance of response to intraductal biliary RFA by genetic tumor characterization using next-generation sequencing, otherOutcomes measure: Overall survival, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Inselspital Bern University Hospital, city: Bern, state: Be, zip: 3010, country: Switzerland, contacts name: Reiner Prof. Dr. med. Wiest, role: CONTACT, phone: +41 31 632 59 41, email: reiner.wiest@insel.ch, contacts name: Martin Prof. Dr. med. Berger, role: CONTACT, phone: +41 31 632 41 14, email: martin.berger@insel.ch, contacts name: Reiner Prof. Dr. med. Wiest, role: PRINCIPAL_INVESTIGATOR, contacts name: Martin Prof. Dr. med. Berger, role: SUB_INVESTIGATOR, geoPoint lat: 46.94809, lon: 7.44744, hasResults: False