CLEAN-DUCT / TRITICC-3 (IKF070) – A Phase IIa, Prospective, Single-Arm, Open-Label, Non-Randomized, Multi-Center Pilot Study of Durvalumab+Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma

Background: The prognosis of patients with non-resectable or metastatic biliary tract cancer (BTC) is dismal. Combining gemcitabine/ cisplatin (GC) and durvalumab has proven efficacy in the TOPAZ-1 trial. Intraductal radiofrequency ablation (ID-RFA) was suggested to improve stent patency, rates of cholangitis, and long-term survival in patients receiving systemic treatment for non-resectable or metastatic extrahepatic biliary tract cancer. Combining immunochemotherapy with ID-RFA might further improve the therapeutic outcome in these patients when given as first-line treatment.

Methods: CLEAN-DUCT/ TRITICC-3 (IKF070) is an interventional, prospective, open-label, non-randomized, exploratory, multicenter, single-arm phase IIa clinical trial performed at 15 sites with expertise in managing BTCs across Germany. A total of 42 adult patients with histologically verified non-resectable or metastatic extrahepatic biliary tract cancer will be included to receive a combination of GC / durvalumab plus ID-RFA. Study treatment will be continued until disease progression or occurrence of unacceptable toxicity. The effect of GC/ durvalumab plus ID-RFA on 12 months survival, defined as the proportion of patients alive 12 months after enrollment, will be analyzed as the primary endpoint. Safety (according to NCI-CTCAE), overall survival, and the time to occurrence of cholangitis are secondary endpoints. A comprehensive translational research program is part of the study and might provide findings about predictive markers concerning response, outcome, and resistance to treatment.

Discussion: CLEAN-DUCT/ TRITICC-3 aims to evaluate the safety and efficacy of GC/ durvalumab in combination with ID-RFA as the first-line treatment of patients with non-resectable or metastatic extrahepatic biliary tract cancer.

Publication History

Article published online:
20 January 2025