Ultra-stable Iodized Oil-Chemo Embolization Seq Thermal Ablation in Early Liver Ca (NCT07493070) | Clinical Trial Compass
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 range
18 Years – 60 Years
Sex
ALL
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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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complete remission rate
Timeframe: "From enrollment to the end of treatment at 1 year"