NCT07493070

Ultra-stable Iodized Oil-Chemo Embolization Seq Thermal Ablation in Early Liver Ca

A Clinical Study on the Use of Ultra-stable Homogeneous Iodized Oil - Chemotherapy Drug Formulation for Sequential Thermal Ablation After TACE Treatment for Unresectable/ Unwilling-to-surgery-resected Early-stage Liver Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fujian Medical University Union Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Background: In the treatment of liver cancer, TACE (transarterial chemoembolization) combined with ablation is commonly used. The chemotherapeutic drug iodized oil emulsion prepared by the ultra-stable homogeneous mixture formulation technology (SHIFT) is stable, efficient, and has low toxicity. However, its effectiveness has not been verified in the post-TACE thermal ablation treatment. Objective: To evaluate the efficacy and safety of the ultra-stable homogeneous iodized oil-chemotherapy drug formulation in the treatment of patients with unresectable/ unwilling to undergo surgical resection early hepatocellular carcinoma in the sequential TACE and thermal ablation therapy. Method: A prospective, single-arm, single-center, non-blinded study included 30 patients with stage Ia and some stage Ib hepatocellular carcinoma. They received TACE combined with thermal ablation using the ultra-stable homogeneous iodized oil-chemotherapy drug formulation, and then underwent enhanced MR to evaluate the complete response rate (CR) and other efficacy and safety indicators.

Detailed description

In the field of early liver cancer treatment where the cancer is not resectable or the patient refuses surgical resection for various reasons, the combined treatment approach of hepatic artery chemotherapy embolization (TACE) and ablation has become a commonly used and effective therapeutic method in clinical practice. The traditional combined treatment model mainly relies on traditional iodized oil embolic agents. However, this embolic agent has exposed many problems in practical application. On one hand, the drug stability is insufficient. After entering the human body, the mixed state of iodized oil and chemotherapy drugs is difficult to maintain for a long time, resulting in uneven drug release at the target site and the inability to fully exert the killing effect of the chemotherapy drugs. On the other hand, after embolization, hypoxia is prone to occur, reducing the oxygen supply to the local tumor tissue. This not only affects the sensitivity of tumor cells to chemotherapy drugs but also may activate some hypoxia adaptation mechanisms of tumor cells, promoting tumor progression and metastasis. These problems seriously restrict the further improvement of the efficacy of the existing combined treatment. With the continuous development of medical technology, the ultra-stable homogeneous mixture formulation technology has emerged. The chemotherapy drug iodized oil emulsion prepared by this advanced technology has many significant advantages. It can maintain high stability, ensuring that the iodized oil and the chemotherapy drug are uniformly mixed in the body for a long time, allowing the drug to be precisely and continuously released into the tumor tissue, thereby improving the utilization rate of the drug and the therapeutic effect. At the same time, this emulsion also has the characteristics of high efficiency and low toxicity. It effectively kills tumor cells while causing less damage to normal tissues, reducing adverse reactions during the treatment process for patients and improving their quality of life. However, although the chemotherapy drug iodized oil emulsion prepared by the ultra-stable homogeneous mixture formulation technology has many theoretical advantages, it has not yet been verified for its effectiveness and safety in the specific scenario of thermal ablation treatment after TACE. Based on this, this study aims to fill this gap and evaluate the efficacy and safety of the ultra-stable homogeneous iodized oil - chemotherapy drug formulation in patients with early hepatocellular carcinoma that is either unresectable or unwilling to undergo surgical resection, during the sequential TACE and thermal ablation treatment. In the design of the research plan, a prospective, single-arm, single-center, non-blinded research model was adopted. It is planned to include 30 eligible patients with stage Ia and some stage Ib hepatocellular carcinoma. These patients will receive ultra-stable homogeneous iodized oil - chemotherapy drug TACE combined with thermal ablation therapy. After the treatment, comprehensive evaluations of efficacy indicators such as complete response rate (CR) will be conducted through advanced imaging examination methods such as enhanced MR. At the same time, adverse reactions that may occur during and after the treatment will be closely monitored to assess the safety of this treatment plan. The general research process is as follows: Firstly, detailed informed consent is provided to patients who meet the inclusion criteria, ensuring that they fully understand the purpose, process, potential risks and benefits of the study. After the patients sign the informed consent form voluntarily, they are officially included in the study. Then, a comprehensive pre-treatment assessment is conducted for the patients, including physical condition, liver function, tumor size and location, etc., to accurately determine whether they have treatment indications and exclude patients with treatment contraindications, ensuring the safety and effectiveness of the treatment. After confirming that the patients are suitable for treatment, TACE therapy is performed for them. Through precise interventional operations, the stable homogeneous iodized oil - chemotherapy drug formulation is injected into the hepatic artery to achieve the dual purposes of embolizing tumor blood vessels and local chemotherapy. After the surgery, combined ablation therapy is carried out according to the specific conditions of the patients, further killing tumor cells. One to two months after the surgery, the patients are scheduled for a follow-up visit. Through enhanced MR and other examination methods, the treatment effect is preliminarily evaluated, observing changes in tumor size, shape, etc., and calculating efficacy indicators such as complete remission rate. At the same time, various adverse reactions that the patients have experienced during and after the treatment, such as fever, pain, abnormal liver function, etc., are recorded in detail, and the safety of the treatment plan is evaluated. Finally, the patients are followed up for one year, continuously monitoring the changes in their condition and survival status, providing data support for the long-term efficacy evaluation of the study.

Conditions

• Hepatocellular Carcinoma (HCC)

Interventions

Type	Name	Description
PROCEDURE	TACE combined with thermal ablation	TACE therapy is performed. Through precise interventional operations, the stable homogeneous iodized oil - chemotherapy drug formulation is injected into the hepatic artery to achieve the dual purposes of embolizing tumor blood vessels and local chemotherapy. After TACE, combined ablation therapy is carried out according to the specific conditions of the patients, further killing tumor cells.

Timeline

• Start date: 2026-02-10
• Primary completion: 2027-08-31
• Completion: 2027-11-30
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: China