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RECRUITING
NCT07356531
NA

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

View on ClinicalTrials.gov

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

DEVICE

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