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Adjuvant TACE in HCC With High-risk Recurrence Factors

NCT07417397 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2026-02-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

OTHER

Intensive follow-up

The patients will receive intensive follow-up.

Sponsors & Collaborators

  • Guangxi Medical University

    lead OTHER

Principal Investigators

  • Jian-Hong Zhong · Guangxi Medical University Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07417397 on ClinicalTrials.gov