| Title: |
Ablatio-bilica: safety of biliary intraductal radiofrequency ablation in patients with unresectable extrahepatic biliary tract cancer undergoing systemic anti-tumor therapy: a phase II, multi-center, randomized, and controlled study |
| Authors: |
Tabea Pfister; Samantha Chun Wai Chan; Sven Trelle; Simon Bütikofer; Ralph Winterhalder; Thibaud Koessler; Christoph Schlag; Ralph Fritsch; Jean-Louis Frossard; André Moser; Martin D. Berger; Reiner Wiest |
| Source: |
Frontiers in Oncology, Vol 15 (2026) |
| Publisher Information: |
Frontiers Media S.A. |
| Publication Year: |
2026 |
| Collection: |
Directory of Open Access Journals: DOAJ Articles |
| Subject Terms: |
extrahepatic biliary duct cancers; immune-checkpoint inhibitor; phase II trial; radio frequency ablation; safety; Neoplasms. Tumors. Oncology. Including cancer and carcinogens; RC254-282 |
| Description: |
BackgroundUnresectable and/or metastatic extrahepatic biliary tract cancer (EBTC) presents a clinical challenge with high mortality rates despite therapeutic advancements, for example, chemotherapy + immune checkpoint inhibitors (CICI). One critical aspect is biliary obstruction, which compromises liver function, is associated with complications, and limits the applicability of systemic treatment (chemotherapy with or without ICI). Endoscopic interventions with stent placement alleviate biliary obstruction and, hence, are standard of care. However, stent patency issues and tumor progression remain challenges, prompting the exploration of adjunctive therapies. Biliary radiofrequency ablation (bRFA) induces local tumor destruction, improves stent patency, and potentially boosts the immune response against cancer cells, being synergistic with CICI. Randomized controlled trials (RCT) demonstrated improved overall survival in EBTC but have not been performed in the setting of CICI and have not focused on rate and severity of adverse events (AE). Nonetheless, multiple current meta-analyses propose the use of bRFA in malignant biliary obstruction without high-quality data on its safety in combination with CICI.HypothesisWe hypothesize that bRFA in patients with unresectable and/or metastatic EBTC undergoing systemic treatment (chemotherapy with or without immunotherapy) is safe.MethodsThis is a randomized-controlled clinical trial (RCT) comparing chemotherapy with or without ICI plus endoscopic stenting (n = 12) versus chemotherapy with or without ICI plus endoscopic stenting and bRFA (n = 24) being allocated in a 1:2 ratio. The primary endpoint is the proportion of severe treatment-related adverse events (grade 3 or 4) leading to permanent discontinuation of all active chemotherapeutic drugs up to six months after enrolment.DiscussionOur findings will provide valuable insights into the role of bRFA as a supplementary treatment in unresectable and/or metastatic EBTC in conjunction with systemic treatment. In case this ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| ISBN: |
978-2-493-45611-3; 2-493-45611-4 |
| Relation: |
https://www.frontiersin.org/articles/10.3389/fonc.2025.1576401/full; https://doaj.org/toc/2234-943X; https://doaj.org/article/24934561142b419fb0ee532ccaa1b48d |
| DOI: |
10.3389/fonc.2025.1576401 |
| Availability: |
https://doi.org/10.3389/fonc.2025.1576401; https://doaj.org/article/24934561142b419fb0ee532ccaa1b48d |
| Accession Number: |
edsbas.BF09CC62 |
| Database: |
BASE |