Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer
NCT07356531 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 216
Last updated 2026-01-21
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).
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.
Sponsors & Collaborators
-
JIANGSU SHENMING Medical Technology CO., Ltd
lead INDUSTRY
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
- 2024-07-29
- Primary Completion
- 2025-11-14
- Completion
- 2026-05-31
Countries
- China
Study Locations
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