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Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
Sponsor: JIANGSU SHENMING Medical Technology CO., Ltd
Summary
This is a prospective, multicenter, randomized, parallel-controlled, non-inferiority clinical trial that will be conducted at multiple clinical trial institutions in China. The trial is divided into two phases: the lead-in phase and the main study phase, with a total of 216 subjects planned to be enrolled. In the main study phase, subjects will be randomly assigned in a 1:1 ratio to either the test group or the control group. The randomly assigned subjects will receive TACE treatment. The test group will receive embolization therapy with anthracycline chemotherapy drugs, iodinated oil, and tumor temperature-sensitive embolic agents (test group), while the control group will receive embolization therapy with anthracycline chemotherapy drugs, iodinated oil, and gelatin sponge particles (control group).
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
216
Start Date
2024-07-29
Completion Date
2026-05-31
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
Transcatheter Arterial Chemoembolization
In the main research stage, the researchers randomly confirmed the subject groups, and the experimental group used anthracycline chemotherapy drugs, iodized oil, and tumor thermosensitive embolization agents for embolization; The control group was treated with anthracycline chemotherapy drugs, iodized oil, and gelatin sponge particles embolization for embolization.
Locations (15)
Anhui Provincial Hospital
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Affiliated Cancer Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The Fourth Hospital of Hebei Medical University (Hebei Provincial Cancer Hospital)
Shijiazhuang, Hebei, China
Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Yichang Central People's Hospital
Yichang, Hubei, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Jilin Guowen Hospital
Gongzhuling, Jilin, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Lishui Central Hospital
Lishui, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China