RecruitingKlatskin Tumor
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
The objective of this study is to evaluate the efficacy of stereotactic body radiation therapy (SBRT) as additional treatment after standard chemotherapy regarding tumor local control, toxicity, progression-free survival (PFS), overall survival and quality of life. In addition, the objective is to explore the value of immunodynamics in peripheral blood for predicting PFS in patients undergoing chemotherapy.
Sponsor: Erasmus Medical Center
You may qualify if…
- ✓ In order to be eligible to participate in the translational part of the study, a subject must be discussed in a liver tumor board, should be eligible for gemcitabine-based chemotherapy (and immunotherapy, if applicable), and should meet all of the following criteria pre-chemotherapy:
- ✓ Perihilar cholangiocarcinoma (pCCA) according to the criteria of the Mayo Clinic, Rochester: a positive or strongly suspicious intraluminal brush cytology or biopsy, or a radiographic malignant appearing stricture plus either: CA 19-9\>100 U/ml in the absence of acute bacterial cholangitis, or polysomy on fluorescence in situ hybridization (FISH), or a well-defined mass on cross sectional imaging
- ✓ One tumor mass
- ✓ Unresectable tumor or patient deemed unfit for surgery
- ✓ T1-T4 (AJCC staging 8th edition), N0-N2-M0 (AJCC staging 8th edition), radiologically or pathologically suspect. N1 is defined as one to three affected lymph nodes typically involving the hilar, cystic duct, common bile duct, hepatic artery, posterior pancreatoduodenal, and portal vein lymph nodes. N2 is defined as four or more affected lymph nodes from the sites described for N1. Endoscopic ultrasound (EUS) is leading in identifying pathological lymph nodes compared to CT.
- ✓ In case of (underlying) liver cirrhosis: Child-Pugh A
- ✓ Age ≥ 18 years
- ✓ ECOG performance status 0-1
You may not qualify if…
- ✕ Prior surgery or transplantation of the liver
- ✕ Tumor extension in stomach, colon, duodenum, pancreas or abdominal wall
- ✕ Ascites
- ✕ Prior radiotherapy to the liver
- ✕ Current pregnancy
- ✕ Affected lymph nodes outside the regions described in the inclusion criteria
- ✕ Progression (local or distant) during or after chemotherapy
Source: ClinicalTrials.gov · NCT06493734 · last updated 2025-07-15