Adjuvant TACE in HCC With High-risk Recurrence Factors

Sponsor
Guangxi Medical University
Study ID
NCT07417397
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Adjuvant transarterial chemoembolization — DRUG
    For patients in the adjuvant TACE group, after superselective catheterization near the hepatic resection margin, embolization will be performed using an emulsion of 50 mg lobaplatin and 3-5 mL ethiodized poppyseed oil. This chemotherapeutic regimen is adopted from previous RCTs that showed adjuvant TACE significantly reduces postoperative HCC recurrence. The use of polyvinyl alcohol embolic microspheres is not part of the standard adjuvant TACE protocol. In the intensive follow-up group, hepatic arteriography will be performed without subsequent administration of embolic agents or chemotherapeutic drugs. Post-procedure, the catheter and arterial sheath will be removed, with compression applied to the puncture site for hemostasis. The intervention group will receive adjuvant TACE only once.
  • Intensive follow-up — OTHER
    The patients will receive intensive follow-up.

Study Details

The 5-year recurrence rate after curative hepatectomy of hepatocellular carcinoma (HCC) remains as high as 70%. According to the Chinese Liver Cancer Staging (CNLC), transarterial chemoembolization (TACE) is strongly recommended as an adjuvant therapy after curative hepatectomy, aiming to reduce postoperative recurrence and ultimately improve overall survival. However, the effectiveness of such adjuvant postoperative therapy remains controversial. In contrast, guidelines from other countries or regions do not recommend adjuvant TACE after curative hepatectomy. This discrepancy may stem from the fact that adjuvant TACE primarily serves to detect intrahepatic residual lesions via digital subtraction angiography, rather than exerting preventive or therapeutic effects through the embolic agents or chemotherapeutic drugs themselves. This study will evaluate the impact of adjuvant TACE on recurrence-free survival in HCC patients with high-risk recurrence factors who have undergone curative hepatectomy. This study is a Phase III randomized controlled trial in which a total of 442 eligible participants will be randomized in a 1:1 ratio to either the adjuvant TACE group or the intensive follow-up group. The two groups will be compared with respect to recurrence-free survival, overall survival, incidence of treatment-related adverse events and serious adverse events, incidence of treatment discontinuation due to treatment-related adverse events or serious adverse events, median recurrence-free survival, and time to recurrence.

Key Dates

First listed
Feb 18, 2026
Start date
Feb 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
442 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Adjuvant transarterial chemoembolization
    For patients in the adjuvant TACE group, after superselective catheterization near the hepatic resection margin, embolization will be performed using an emulsion of 50 mg lobaplatin and 3-5 mL ethiodized poppyseed oil. This chemotherapeutic regimen is adopted from previous RCTs that showed adjuvant TACE significantly reduces postoperative HCC recurrence. The use of polyvinyl alcohol embolic microspheres is not part of the standard adjuvant TACE protocol. In the intensive follow-up group, hepatic arteriography will be performed without subsequent administration of embolic agents or chemotherapeutic drugs. Post-procedure, the catheter and arterial sheath will be removed, with compression applied to the puncture site for hemostasis. The intervention group will receive adjuvant TACE only once.
  • Active Comparator: Intensive follow-up
    The patients will receive intensive follow-up.

Primary Outcome Measure

Recurrence-free survival [ Time Frame: two years ]

Central Contacts

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