Active — Not RecruitingNot Applicable

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

China30 participantsStarted 2026-02-10

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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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 dis…

What they're measuring

Complete remission rate

Timeframe: "From enrollment to the end of treatment at 1 year"

Trial details

NCT IDNCT07493070

SponsorFujian Medical University Union Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-31