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Brief Title: Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies
Official Title: A Randomized Phase II Trial of Nal-IRI and 5-Fluorouracil Compared to 5-Fluorouracil in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies
Study ID: NCT03043547
Brief Summary: is an open label, randomized, multicenter phase II trial
Detailed Description: The primary objective is to assess the efficacy of nal-IRI in gemcitabine pre-treated patients with advanced, unresectable and metastatic cholangio- and gallbladder carcinoma eligible for treatments after failure to respond to a gemcitabine-based treatment
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover, Hannover, , Germany
Name: Arndt Vogel, Prof.
Affiliation: Klinik für Gastroenterologie, Hepatologie und Endokrinologie, Medizinische Hochschule Hannover
Role: PRINCIPAL_INVESTIGATOR