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

Fujian Medical University (FJMU)

Status: Active, not recruiting

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Procedure: TACE combined with thermal ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT07493070

2026KY009-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) The patient's gender is not restricted, and the age is between 18 and 60 years old, with an expected lifespan of ≥ 3 months; (2) Patients diagnosed with primary hepatocellular carcinoma confirmed by histological or cytological examination, or meeting the clinical diagnostic criteria of the "Primary Liver Cancer Diagnosis and Treatment Guidelines" (2024 Edition) issued by the National Health Commission (including chronic liver disease background, typical imaging features, and changes in AFP); (3) CNLC stage Ia and some Ib stage liver cancer (i.e., a single tumor with a diameter of ≤ 5 cm; or 2 to 3 tumors with the maximum diameter of ≤ 3 cm) (those who are not suitable for or unwilling to undergo surgical resection); (4) No vascular invasion of the portal vein, hepatic vein, etc.; (5) Liver function is Child-A grade or can be corrected after liver protection, nutritional fluid therapy, etc.; (6) Eastern Cooperative Oncology Group Status Score (ECOG PS) ≤ 2; (7) After treatment, the following indicators are achieved: white blood cell count ≥ 9.5×109/L and ≤ 3.0×109/L; platelet count ≥ 350×109/L and ≤ 50×109/L; prothrombin time (PT) does not exceed the upper limit of the normal control by 5 seconds; serum creatinine is less than 1.5 times the upper limit of the normal; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 3 times the upper limit of the normal; (8) Clearly inform the patient of the possible advantages and disadvantages before and after the surgery, and the patient and his/her family voluntarily choose the treatment plan and sign the informed consent form.

Exclusion criteria

• (1) Patients who have received non-radical treatment for liver cancer (including external radiotherapy, molecular targeted drugs, immunotherapies, TAI/TAE/TACE treatments, etc.) and whose tumors are still alive, and patients who have experienced tumor recurrence after radical treatment for liver cancer (including surgical resection, ablation therapy) can be included in this study; (2) Portal vein or hepatic vein invasion; (3) Patients with already diagnosed malignant tumors in other parts; (4) Severe diseases of important organs such as heart, lungs, kidneys, and brain; (5) Complications of TACE contraindications: diffuse-type liver cancer or tumor volume accounting for 70% or more of the entire liver, refractory large amounts of ascites, high-flow arteriovenous shunt in the liver; total bilirubin > 51 umol/L and/or albumin < 28 g/L, which cannot be improved after symptomatic treatment; combined with active infection, especially inflammation of the biliary system; female patients who are pregnant or breastfeeding; (6) Patients allergic to iodine oil or iodine agents; (7) Patients and/or their families do not agree to participate in the clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Experimental arm

Experimental group

Description:

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 necrosis rate (CR) and other efficacy and safety indicators.

Treatment:

Procedure: TACE combined with thermal ablation