Klinische Studie

Phase-2-Studie über präoperatives Gemcitabin plus Cisplatin mit Durvalumab (MEDI4736) und Tremelimumab bei intrahepatischem Cholangiokarzinom(NeoTreme)To demonstrate safety and feasibility of neoadjuvant Gemcitabine plus Cisplatin with Durvalumab and Tremelimumab in intrahepatic Cholangiocarcinoma by a R0/R1 resection rate
Krankheitsentität(en) Leber
StudientypInterventionsstudiePhase II
Wesentliche EinschlusskriterienMust have a life expectancy of at least 12 weeks. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Age >18 years.
Wesentliche AusschlusskriterienPrior immunotherapy or use of other investigational agents, including prior treatment with an anti-Programmed Death receptor-1 (PD-1), anti-Programmed Death-1 ligand-1 (PD-L1), anti-PD-L2, or anti-cytotoxic T-lymphocyte associated antigen4 (anti-CTLA-4) antibody, therapeutic cancer vaccines. Any other concurrent antineoplastic treatment including chemotherapy, biologic or hormonal therapy or irradiation Any unresolved toxicity NCI CTCAE (V5.0) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
Ansprechpartner & KontaktUniversitätsklinikum RegensburgChirurgieStudienzentrale0941 9446736cotrialassociates(at)ukr.de