OncoMatch/Clinical Trials/NCT06440993
Durvalumab + Intraductal Radiofrequency Ablation (ID-RFA) in Extrahepatic Cholangiocarcinoma
Is NCT06440993 recruiting? Yes, currently enrolling (May 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
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.
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