Phase 2Recruiting
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extra- and Intrahepatic Cholangiocarcinoma
The CLEAN-DUCT / TRITICC-3 Trial - Phase IIa, Prospective, Single Arm, Open Label, Non-randomized, Multi-center Pilot Study of Durvalumab (MEDI4736) + Intraductal Radiofrequency Ablation (ID-RFA) in Extra- and Intrahepatic Cholangiocarcinoma
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (Academic or other)
- Enrollment
- 42 planned
- Conditions
- Extrahepatic Cholangiocarcinoma; Unresectable Perihilar or Ductal CCA
- Interventions
- Gemcitabine; Cisplatin; Durvalumab; ID-RFA
- Ages
- adults, older adults
- Registry
- NCT06440993, CTIS2023-509165-21-00
Full record on ClinicalTrials.gov
From the registry
The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial. Patients with unresectable perihilar and/or ductal or intrahepatic CCA with indication for bile duct stenting and palliative systemic therapy as determined by the local multidisciplinary team (MDT), who already resolved cholestasis due to RFA + Stent will be enrolled. We hypothesize that in patients with extra- and intrahepatic cholangiocarcinoma, the use of a combination radiofrequency ablation followed by systemic treatment with chemotherapy plus durvalumab might further increase the anti-tumor activity.
Primary outcomes
- Overall survival rate
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered