Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2014-09-17
2023-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SIRT
SIRT Yttrium-90
Interventions
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SIRT Yttrium-90
Eligibility Criteria
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Inclusion Criteria
* Histological or cytological diagnosis of cholangiocarcinoma
* Disease not amenable to surgery
* Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed)
* Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable)
* ECOG PS 0-1
* At least one measurable disease lesion according to RECIST v 1.1
* Life expectancy of 12 weeks or longer
* Adequate hematological, renal and hepatic function
* Platelet ≥100 x 109
* ANC ≥ 1.5 x 109
* Bilirubin ≤ 30µmol/L
* Albumin ≥ 30g/L
* ALT ≤ 3 ULN
* INR ≤ 1.5
* Serum creatinine ≤ 1.5 x ULN
Exclusion Criteria
* Patients with extra-hepatic disease other than regional lymph node metastases.
* Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment
* Biliary obstruction with no possibility of drainage
* Non-malignant disease that would render the patient unsuitable for treatment according to the protocol
* Prior treatment of chemotherapy for the cholangiocarcinoma
* Prior radiation therapy to the upper abdomen
* Complete thrombosis of the main portal vein
* Tumor volume \> 50% of the normal liver volume
* Allergy to non-ionic contrast agents
18 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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CCTU
Comprehensive Clinical Trial Unit
Principal Investigators
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Stephen L Chan, FRCP
Role: PRINCIPAL_INVESTIGATOR
Department of Clinical Oncology, The Chinese University of Hong Kong
Locations
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Department of Clinical Oncology, Prince of Wales Hospital
Hong Kong, , Hong Kong
Countries
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Other Identifiers
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BTC001
Identifier Type: -
Identifier Source: org_study_id
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