Adjuvant TACE in HCC With High-risk Recurrence Factors

February 11, 2026 updated by: Jian-Hong Zhong, Guangxi Medical University

The Efficacy and Safety of Adjuvant TACE in Radical Surgery for Hepatocellular Carcinoma With High-risk Recurrence Factors: A Phase III Randomized Controlled Clinical Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

442

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Nanning, China, 530021
        • Recruiting
        • Guangxi Medical University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jian-Hong Zhong, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 at enrollment;
  • Child-Pugh class A or B7 (score 5-7);
  • having undergone radical hepatic resection at one of the study centers;
  • histopathologically confirmed HCC;
  • undergo hepatic angiography 4-8 weeks after surgery, with confirmation of no intrahepatic tumor staining;
  • have no prior systemic anti-tumor therapy for HCC;
  • have adequate organ and bone marrow function;
  • estimated life expectancy >6 months;
  • present with at least one high-risk factor for recurrence (such as tumor rupture; maximum tumor diameter >5 cm; multifocal tumors; microvascular invasion on postoperative pathology; Vp1/Vp2 portal vein invasion; lymph node metastasis confirmed by postoperative pathology; positive or narrow surgical margin; and Edmondson grade Ⅲ-Ⅳ differentiation).

Exclusion Criteria:

  • absence of pathological confirmation of HCC;
  • diagnosis of other malignancies within the 5 years prior to enrollment;
  • a history of hepatic encephalopathy, liver transplantation, pleural effusion, ascites, or pericardial effusion with clinical symptoms after curative hepatectomy, as well as a history of drug allergy, active pulmonary tuberculosis, active syphilis infection, autoimmune disease, or long-term glucocorticoid use;
  • participants who have experienced severe infections within 4 weeks before the first dose, or who have previously received systemic anti-tumor therapy;
  • pregnant or lactating women are ineligible for participation;
  • participants who are unable to comply with the treatment regimen or complete the follow-up requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Active Comparator: Intensive follow-up
The patients will receive intensive follow-up.
Other: Intensive follow-up
The patients will receive intensive follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival
Time Frame: two years
The primary outcome is RFS, defined as the time from the date of randomization to the first occurrence of HCC recurrence, as identified by imaging.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Principal Investigator: Jian-Hong Zhong, Guangxi Medical University Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREVENT-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Outcome data.

IPD Sharing Time Frame

After the finial analysis is published in a journal.

IPD Sharing Access Criteria

Ask the corresponding author: zhongjianhong66@163.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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