Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization (e.g., Health Insurance Portability and Accountability Act in the US, European Union [EU] Data Privacy Directive in the EU) obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Histologically or pathologically confirmed CCA
Age >18 years at time of study entry.
Eastern Cooperative Oncology Group (ECOG) 0 or 1.
Any previous participation in another clinical interventional study.
Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
History of allogenic organ transplantation.
Patients with vitiligo or alopecia
Single group
Durvalumab 1120 mg
DrugDurvalumab 1120 mg day 1 i.v
Durvalumab 1500 mg
DrugDurvalumab i.v. at 1500 mg once every 4 weeks
Tremelimumab i.v. at 300 mg
DrugSingle dose
Cisplatin (CDDP) 25 mg/mq i.v
Combination productFour cycles
Gemcitabine (GEM) 1000 mg/mq i.v.
Combination productDays 1 and 8 every 21 days
Recurrence rate of CCA
To determine whether neoadjuvant chemo- and immunotherapy decrease the recurrence rate of CCA at 12 months after surgery.
Rate of R0 resections
Rate of R0 resections (number of resections with surgical margins free from cancer/total number of resections) as assessed by pathologic examination (R1: microscopic disease.
Radiologic responses
Radiologic responses evaluated through the RECIST v1.1 criteria.
Pathologic responses
Pathologic responses (number of surgically removed tumour specimens with absence of any residual viable neoplastic cells).
Toxicity assessed
Toxicity assessed by the NCI CTCAE v5.0
Exploratory objectives
Characterization of tumor microenvironment of primary CCAs and eventually resected metastases treated with neoadjuvant sequential chemo-immuno-therapy
Exploratory objectives
Depiction of mutational evolution of CCA through NGS (Next Generation Sequencing) gene analysis on primary tumor biopsies and matched metastases (FFPE tissues or liquid biopsies).
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