Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients
NCT02956772 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190
Last updated 2017-02-23
Summary
A multicentre, randomized, open-label, parallel-group, active controlled study.
Conditions
- Primary Hepatocellular Carcinoma
Interventions
- DRUG
-
TACE
After the puncture of femoral artery via Seldinger method, a catheter was inserted and digital celiac axis or hepatic arteriography performed. Then a microcatheter was used to infuse chemotherapeutic agent (30 to 60 mg of pirarubicin) mixed with 5 to 20 mL of Lipiodol Ultra-Fluid. Embosphere microspheres (size of 100 to 300 um) were inserted for embolization.
- DRUG
-
Arsenic trioxide
Arsenic trioxide 10 mg is put into 500 ml saline solution and then administrated by continuous intravenous drip for 5 hours during a treatment day.
Sponsors & Collaborators
-
Hunan Provincial People's Hospital
lead OTHER
Principal Investigators
-
Hua Xiang, Dr. · Hunan Provincial People's Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2019-11-30
- Completion
- 2020-11-30
Countries
- China
Study Locations
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