Irresectable intrahepatic cholangiocellular carcinoma:Evaluation of the Efficacy of multimodal treatment by interstitial HDR-Brachytherapy combined with Gemcitabine/Cisplatin Chemotherapy

Recruiting

Conditions: C22.1
Intrahepatic bile duct carcinoma

Registration Number: DRKS00007161

Lead Sponsor: niversitätsklinikum Magdeburg

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

histologically confirmed cholangiocellular carcinoma
intrahepatic localization of a massforming CCC
whole tumor bound of the liver not > 50%
at least 1 lesion is accessible to an interventional therapy
consent and ability to all study specific actions voluntary, informed and personally written consent
Patient Age not under 18 and not over 85 years
suitable cardiac, renal and haematological parameters

Exclusion Criteria

pregnant or breast-feeding women respectively possible pregnancy
uncontrolled ascites
other tumor diseases within the last 5 years (expect carcinoma in situ of the skin or zervix)
uncooperative/noncompliant
already participant of this study
participation on another therapy study
contraindication for Primovist-MRI or contrast-CT
moderate or graved renal failure (GFR < 60 ml/min) appropriate to laboratory values 1 week before Primovist-MRI
previous Radiation of the liver
to clinic or investigator related patients
acute or risk of acute severe bleeding (WHO grade 3-4)
upper gastrointestinal bleeding in the last 3 month
thrombembolic events including TIA in the last 6 month
uncontrolled hypertonus
life expactancy under 16 weeks
state by orgn transplantation
congenital immune defects
immunsuppressive therapie in case of autoimmune disease or chronic inflammatory disease

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (follow-up time is planed until death of the patient or one year after the inclusion of the last study-patient)

Secondary Outcome Measures

Name	Time	Method
time to uncontrolled local Progression, Overall survival, Quality of life (EQ-5D) (to be completed at time of inclusion, at brachytherapy and at follow up visits every 3 months)