NCT06440993

Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic 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 Extrahepatic Cholangiocarcinoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The present clinical trial is a prospective, investigator-initiated, single-arm, open-label, multicenter phase II trial. Patients with unresectable perihilar and/or ductal 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 extrahepatic cholangiocarcinoma, the use of a combination radiofrequency ablation followed by systemic treatment with chemotherapy plus durvalumab might further increase the anti-tumor activity.

Conditions

• Extrahepatic Cholangiocarcinoma
• Unresectable Perihilar or Ductal CCA

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine, 1,000 mg/m2 IV
DRUG	Cisplatin	Cisplatin, 25 mg/m2 IV
DRUG	Durvalumab	Durvalumab, 1,500 mg IV
PROCEDURE	ID-RFA	endoscopic intraductal RFA

Timeline

• Start date: 2024-08-23
• Primary completion: 2027-01-01
• Completion: 2028-04-01
• First posted: 2024-06-04
• Last updated: 2025-12-01

Locations

10 sites across 1 country: Germany