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NCT07493070

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

Sponsor: Fujian Medical University Union Hospital

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-10

Completion Date

2027-11-30

Last Updated

2026-03-25

Healthy Volunteers

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

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.

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.

Locations (1)

Department of Interventional Radiology, Fujian Medical University Union Hospital

Fuzhou, Fujian, China