Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01798147

Enrollment

Registered

2013-02-25

Start date

2011-02-28

Completion date

2018-06-30

Last updated

2017-05-23

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

Conditions

Intrahepatic Cholangiocellular Carcinoma

Keywords

Cholangiocellular Carcinoma, TACE, SIRT

Brief summary

Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).

Interventions

PROCEDUREDEB TACE

DEB TACE every 6 weeks until either no viable tumor or endpoint reached.

PROCEDURESIRT

Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* ≥18 years * Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9) * Tumor confined to the liver * At least one measurable lesion in magnetic resonance imaging (MRI) * Tumor load ≤ 50% * Preserved liver function (Child Pugh A and B) * ECOG performance status ≤2

Exclusion criteria

* Patients feasible for curative treatment (e.g. resection or local ablation) * Previous TACE or SIRT * Prior Chemotherapy * Child Pugh stage C * ECOG Performance Status \>1 * Tumor involvement \>50% of the liver * Extrahepatic tumor * Serum Bilirubin \>2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine \>2 mg/dl; Leukocytes \<3000/ml; Thrombocytes \<50000/ml * Clinically apparent ascites (ascites only in CT/MRI is no

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS)	at the end of study

Secondary

Measure	Time frame
Overall survival (OS)	at the end of study
Time to progression (TTP)	at the end of study

Countries

Germany

Contacts

Primary ContactRoman Kloeckner, MD

roman.kloeckner@unimedizin-mainz.de++49613117

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026