OncoMatch/Clinical Trials/NCT06440993
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extra- and Intrahepatic Cholangiocarcinoma
Official title: 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
Is NCT06440993 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including Gemcitabine and Cisplatin for extrahepatic cholangiocarcinoma.
Treatment: Gemcitabine · Cisplatin · Durvalumab — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: endobiliary treatment other than RFA
previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy)
Cannot have received: PD-1 inhibitor
previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor
Cannot have received: PD-L1 inhibitor (durvalumab)
previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor
Cannot have received: CTLA-4 inhibitor
previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor
Cannot have received: cytotoxic chemotherapy (platinum, fluoropyrimidine, gemcitabine)
previous systemic therapy with ... classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens
Lab requirements
Blood counts
ANC > 1,500 cells/μL without the use of hematopoietic growth factors; Platelet count ≥ 100 x 10^9/L (>100,000 per mm3); Hemoglobin ≥ 9 g/dL; INR < 2.0 ULN and PTT < 1.5 ULN within 7 days prior to randomization (unless on therapeutic anticoagulation and within therapeutic limits)
Kidney function
Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 60 mL /min
Liver function
Serum total bilirubin ≤ 3x ULN (biliary drainage is allowed for biliary obstruction; elevated bilirubin should be caused by obstruction not impaired liver function as assessed by albumin and INR values); Albumin levels ≥ 2.8 g/dL; AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN
Adequate blood count, liver-enzymes, and renal function: ... see full text for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06440993 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior endobiliary treatment other than RFA, PD-1 inhibitor, PD-L1 inhibitor disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages