NCT03043547

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cholangiocarcinoma Non-resectable
• Cholangiocarcinoma Metastatic
• Cholangiocarcinoma of the Gallbladder
• Cholangiocarcinoma Advanced

Interventions

Type	Name	Description
DRUG	nal-IRI	nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion)
DRUG	5-FU	5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion)
DRUG	leucovorin	leucovorin (400 mg/m2 as 0.5 hour infusion)

Timeline

• Start date: 2017-10-24
• Primary completion: 2021-12-08
• Completion: 2022-03-08
• First posted: 2017-02-06
• Last updated: 2022-05-18

Locations

1 site across 1 country: Germany