The purpose is to prolong survival in patients with cholangiocarcinoma.

Phase 1

• Conditions: patient with metastatic cholangiocarcinoma; MedDRA version: 17.1Level: LLTClassification code 10008594Term: Cholangiocarcinoma non-resectableSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-004854-46-DK
• Lead Sponsor: Herlev University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-04
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Informed consent
•Age > 18 years
•Performance status 0-1
•Patient with histological cholangiocarcinoma or malign cells and a CT-scan in accordance to a cholangiocarcinoma.
•The disease not suitable for surgery
•Neutrofile granulocytes ? 1.5 x 109/l and thrombocytes ? 75 x 109/l
•Bilirubine ? 2.0 x UNL (upper normal limit).
•Creatinine-clearence ? 45 ml/min

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

•Other current or prior malignant disease in the past five years, except adequately treated and cured carcinoma in situ of the cervix or squamous cell carcinoma of the skin.
•The patient is not allowed to participate in other clinical trials with antineoplastic treatment..
•Other severe medical conditions
•Presence of diseases preventing oral therapy
•Patients with uncontrolled infection
•Pregnant or lactating women
•Women capable of childbearing not using a sufficient method of birth control
•Patients not able to understand the treatment or to collaborate
•Known prior hypersensitivity reactions to the agents

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Progression free survival ;Secondary Objective: Tumour response (RECIST version 1.1)<br>b) Survival <br>c) Toxicity<br> <br>;Primary end point(s): Primary endpoint<br><br>Progression free survival <br><br>;Timepoint(s) of evaluation of this end point: six month after last patient were included in the trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints<br>a) Tumour response (RECIST version 1.1)<br>b) Survival <br>c) Toxicity<br> ;Timepoint(s) of evaluation of this end point: 6 month after last patient were included in the trial