Neoplasms

All Conditions

Rare Diseases

Carcinoma

Cholangiocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Bile Duct Cancer

Gallbladder Cancer

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Gemcitabine

Leucovorin

Fluorouracil

Irinotecan

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Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion), 5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w)

Control intervention/standard arm: 5-FU (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w)

nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion)

nal-IRI

5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion)

5-FU

leucovorin (400 mg/m2 as 0.5 hour infusion)

leucovorin

Arndt Vogel, Prof.

is an open label, randomized, multicenter phase II trial

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

Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies

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

will be collected to potentially identify factors that may correlate with tumour response, sensitivity or resistance to nal-IRI

Response Evaluation Criteria in Solid Tumors (RECIST 1.1.)

according to Common Terminology Criteria for Adverse Events

Spots Global Cancer Trial Database for cholangiocarcinoma advanced