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
NA
126 participants
INTERVENTIONAL
2021-03-01
2023-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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REMS+TAI
Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
REMS+TAI
Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
SEMS+TAI
Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
SEMS+TAI
Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
Interventions
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REMS+TAI
Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
SEMS+TAI
Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
Eligibility Criteria
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Inclusion Criteria
* With symptoms such as jaundice related to biliary obstruction
* Biliary obstruction of Bismuth-Correlate Classification Type III or IV
* Unresectable disease confirmed by multidisciplinary team
* Maximum diameter of lesion ≤3 cm
* Liver function of Child-Pugh A or B
* 18 years older
* With an expected survival time ≥ 3 months
* With an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Meet the following laboratory test parameters: hematologic function (absolute neutrophil count ≥ 1.0×10⁹/L; platelet count ≥ 50×10⁹/L; hemoglobin ≥ 90 g/L; INR \< 1.7 or prolonged prothrombin time not more than 4 seconds); liver function (ALT/AST not more than 5 times the upper limit of normal; albumin ≥ 28 g/L); renal function (serum creatinine not more than 1.5 times the upper limit of normal)
Exclusion Criteria
* With another malignancy type other than cholangiocarcinoma
* Previous history of biliary stent placement
* Moderate to severe ascites (ascites up to Child-Pugh score of 3)
* Biliary perforation
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to enrollment
* Unstable angina, myocardial infarction, coronary artery bypass graft, congestive heart failure, cerebrovascular accident (including transient ischemic attack, pulmonary embolism) within 3 months before enrollment
* Persistent arrhythmia (CTCAE criteria grade 2 and above), atrial fibrillation of any degree, prolonged Qtc interval (more than 450 ms in men and more than 470 ms in women)
* Refractory hypertension (blood pressure above 150/100 mmHg even after optimal drug therapy
* Concomitant receipt of other anti-tumor drugs
* Concomitant human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome
* Pregnant or lactating women
* Concomitant acute or chronic mental disorders (including mental disorders affecting subject enrollment, therapeutic intervention, and follow-up)
18 Years
ALL
No
Sponsors
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Zhongda Hospital
OTHER
Responsible Party
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Jin-He Guo
Deputy Director, Center of Interventional Radiology & Vascular Surgery
Principal Investigators
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Jin-He Guo, MD
Role: PRINCIPAL_INVESTIGATOR
Zhongda Hospital
Locations
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Zhongda Hospital,Southeast University
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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REMS-TAI-HC-2021
Identifier Type: -
Identifier Source: org_study_id
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