About this trial
Neoadjuvant chemo- and immunotherapy ameliorate the recurrence rate of cholangiocarcinoma (CCA) at 12 months after surgery.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Durvalumab 1120 mg
- Durvalumab 1500 mg
- Tremelimumab i.v. at 300 mg
- Cisplatin (CDDP) 25 mg/mq i.v
- Gemcitabine (GEM) 1000 mg/mq i.v.