NCT07356531

Clinical Trial Evaluating the Safety and Efficacy of Tumor Thermosensitive Embolic Agent in Transcatheter Arterial Chemoembolization for Primary Liver Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 216 (estimated)
• Sponsor: JIANGSU SHENMING Medical Technology CO., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The purpose of this study is to evaluate the safety and effectiveness of the tumor thermosensitive he main efficacy evaluation indicator of this clinical trial is disease control rate. This indicator is widely regarded as a reflection of the effectiveness of tumor treatment, indicating the proportion of tumors that completely disappear, shrink, or remain stable after TACE treatment. Analyzing the results of the subjects, indirectly and directly reflecting clinical benefits, is preliminary reliable evidence of anti-tumor activity in treatment. As the main purpose of this experiment is to evaluate the tumor response of liver tumors treated with TACE using tumor thermosensitive embolic agents and compare it with gelatin sponge embolic agents,

Conditions

• Liver Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-29
• Primary completion: 2025-11-14
• Completion: 2026-05-31
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

15 sites across 1 country: China