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.
Patient* has given written informed consent.
Patient is ≥ 18 years of age at time of signing the written informed consent.
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Patient has been diagnosed with histologically or cytologically confirmed
Patient received previous or simultaneous endobiliary treatment other than RFA (e.g. PDT or brachytherapy)
Patient received previous systemic therapy with a PD-1, PD-L1 inhibitor (including durvalumab) or CTLA4 inhibitor or classical chemotherapy agents like platinum, fluoropyrimidine or gemcitabine-based regimens.
Patient receives any concurrent chemotherapy, investigational product or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer related conditions (e.g., hormone replace therapy) is acceptable.
Patient has known hypersensitivity to any component of the durvalumab formulation as well as a known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion protein and/or any known contraindication (including hypersensitivity) to gemcitabine or cisplatin.
Single group
Gemcitabine
DrugGemcitabine, 1,000 mg/m2 IV
Cisplatin
DrugCisplatin, 25 mg/m2 IV
Durvalumab
DrugDurvalumab, 1,500 mg IV
ID-RFA
Procedure/Surgeryendoscopic intraductal RFA
Overall survival rate
Overall survival rate after 12 months (OS@12months) defined as proportion of patients alive 12 months after enrollment
Progression-free survival (PFS)
Progression-free survival (PFS) defined as time from enrollment to the date of disease progression or death from any cause
Overall survival (OS)
Overall survival (OS) Defined as time from enrollment to the date of death from any cause
Incidence and nature of adverse events using NCI CTCAE 5.0
Assessment of safety of the treatment as determined by the incidence, nature, causality, frequency, timing and severity of adverse events using NCI CTCAE 5.0
Time to cholangitis
Time to cholangitis Defined as time from enrollment to the date of confirmed cholangitis
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Universitätsklinikum Düsseldorf, Germany
Collaborator
Universitätsklinikum Köln
Collaborator
AstraZeneca
Collaborator
