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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00007161
Enrollment
50
Registered
2016-08-10
Start date
2012-11-15
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C22.1

Interventions

Group 1: 1. Screening: History, ECOG evaluation (to assess how the disease your need for life skills affected), EuroQoL-5D, a pregnancy test in patients of childbearing age, circulatory parameters, bl
on Day 22 starts a new cycle. On days 1 and 8 outpatient chemotherapy with laboratory control, on Day 15, only a blood test done. Patients will receive the basic inital doses of 1000 mg / m2 Gemzar an

Sponsors

Universitätsklinikum Magdeburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Germany

Contacts

Public ContactSusanne Penzlin

Klinik für Radiologie und Nuklearmedizin

susanne.penzlin@med.ovgu.de0391-6713030

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026