Actively Recruiting
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
Led by Erasmus Medical Center · Updated on 2025-07-15
30
Participants Needed
8
Research Sites
191 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Stereotactic Body Radiation Therapy After Chemotherapy for Unresectable Perihilar Cholangiocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with perihilar cholangiocarcinoma confirmed by biopsy or imaging criteria
- One tumor mass present
- Unresectable tumor or not fit for surgery
- Tumor staging T1-T4, lymph node status N0-N2, no distant metastases (M0)
- Child-Pugh class A if liver cirrhosis is present
- Age 18 years or older
- ECOG performance status 0 or 1
- Eligible for gemcitabine-based chemotherapy
- Measurable disease on CT or MRI scans according to RECIST 1.1
- Completed gemcitabine-based chemotherapy, preferably 8 cycles (patients with fewer cycles also eligible)
- Bilirubin level 3.0 times normal or less, AST/ALT 5 times upper limit of normal or less
- Platelets at least 50 x 10^9/L, leukocytes over 1.5 x 10^9/L, hemoglobin over 6 mmol/L
- Able and willing to comply with follow-up schedule
- Able to start SBRT within 12 weeks after chemotherapy completion
- Provided written informed consent for study participation
You will not qualify if you...
- Prior liver surgery or transplantation
- Tumor extending into stomach, colon, duodenum, pancreas, or abdominal wall
- Presence of ascites
- Previous radiotherapy to the liver
- Current pregnancy
- Lymph nodes affected outside defined regional areas
- Tumor progression locally or distantly during or after chemotherapy
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Antwerp University Hospital / Sint-Augustinus Gasthuiszusters
Wilrijk, Antwerp, Belgium, 2610
Not Yet Recruiting
2
University Hospital Brussels / Jules Bordet Institute
Brussels, Brussels Capital, Belgium, 1070
Not Yet Recruiting
3
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
4
Maastricht University Medical Center+ / Maastro Clinic Maastricht
Maastricht, Limburg, Netherlands, 6229 ET
Actively Recruiting
5
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1081 HV
Actively Recruiting
6
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9713 GZ
Actively Recruiting
7
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015 CD
Actively Recruiting
8
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands, 3584 CX
Actively Recruiting
Research Team
A
Alejandra Méndez Romero, MD, PhD
CONTACT
S
Suus van Loosbroek, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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