Neo-adjuvant Chemo and Immunotherapy in the Pre-operAtive Treatment of Locally Advanced CholangIOcarciNoma

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute, Naples

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.

Treatment groups

38 Participants
are divided into 1 treatment group