OncoMatch/Clinical Trials/NCT06440993
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
Is NCT06440993 recruiting? Yes, currently enrolling (Jun 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 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Chemotherapy
Cancer type
Cholangiocarcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: intraductal radiofrequency ablation — prior to inclusion
Patient tolerated RFA prior to inclusion and is eligible for repeat RFA during the study
Cannot have received: endobiliary treatment other than RFA (photodynamic therapy, brachytherapy)
Patient received previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy)
Cannot have received: PD-1 inhibitor
Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor
Cannot have received: PD-L1 inhibitor (durvalumab)
Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor
Cannot have received: CTLA-4 inhibitor
Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor
Cannot have received: platinum-based chemotherapy (cisplatin)
classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens
Cannot have received: fluoropyrimidine
classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens
Cannot have received: gemcitabine-based chemotherapy (gemcitabine)
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
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: ANC > 1,500 cells/μL...; Platelet count ≥ 100 x 10^9/L...; Hemoglobin ≥ 9 g/dL; Serum total bilirubin ≤ 3x ULN...; Albumin levels ≥ 2.8 g/dL; INR < 2.0 ULN and PTT < 1.5 ULN...; AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN unless liver metastases are present, in which case it must be ≤ 5x ULN; Serum Creatinine ≤ 1.5 x ULN and a calculated creatinine clearance rate ≥ 60 mL /min
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.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
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