RecruitingNot ApplicableNCT07356531

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

Enrollment

216 participants

Start Date

Jul 29, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new thermosensitive embolic agent — a substance injected through a blood vessel into a liver tumor to block its blood supply and deliver chemotherapy — during a procedure called TACE (transarterial chemoembolization) for primary liver cancer. Researchers want to see if this new agent is safer and more effective than existing options. **You may be eligible if:** - You are aged 18 to 80 and have been diagnosed with primary liver cancer (hepatocellular carcinoma) - Your cancer requires TACE treatment based on Chinese liver cancer staging guidelines - You have at least one untreated liver tumor up to 10 cm in size that meets standard measurement criteria - You are willing to participate and provide written consent **You may NOT be eligible if:** - Your target tumor has already been treated with surgery, TACE, radiation, or ablation - Your blood counts are too low to safely proceed - You have significant kidney dysfunction or uncorrectable blood clotting problems - The main portal vein (blood vessel to the liver) is completely blocked - You have known allergies to the study drugs, contrast dye, or embolic materials - You are currently using heart rhythm medications called cardiac glycosides - You are pregnant, breastfeeding, or planning to become pregnant - You have other serious cancer spread throughout the body with a life expectancy of less than 90 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETranscatheter 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07356531


Related Trials