Adjuvant TACE in HCC With High-risk Recurrence Factors

NCT07417397 | Recruiting Phase 3 DMC

• 1 other identifier: PREVENT-4
• Study Type: interventional
• Target: 442
• Locations: 1 country
• Sites: 1

Brief 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

Hepatocellular Carcinoma; Adjuvant; Transarterial Chemoembolization

Keywords

transarterial chemoembolization; hepatocellular carcinoma; adjuvant

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival

  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

Study Arms (2)

Adjuvant transarterial chemoembolization

EXPERIMENTAL

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

Intensive follow-up

ACTIVE COMPARATOR

The patients will receive intensive follow-up.

Other: Intensive follow-up

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.

Adjuvant transarterial chemoembolization

Intensive follow-up OTHER

The patients will receive intensive follow-up.

Intensive follow-up

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Guangxi Medical University Cancer Hospital

Nanning, 530021, China

RECRUITING

Related Publications (1)

• Su JY, Huang DJ, Liu SP, Xu XL, Chen SC, Ou JJ, Li JR, Yang TX, Li WY, Fan Y, Wen ZC, Chen L, Qin Z, Long BB, Li DZ, Huang JH, Lu YJ, Zhong JC, Zhu HQ, Ma L, Liang XM, Zhong JH. Adjuvant Transarterial Chemoembolization After Truly Curative Resection Does Not Improve Survival of Patients With Hepatocellular Carcinoma at High Risk of Recurrence: A Target Trial Emulation Study. Hepatol Res. 2025 Sep;55(9):1263-1273. doi: 10.1111/hepr.14219. Epub 2025 Jun 16.

  PMID: 40522319 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jian-Hong Zhong

  Guangxi Medical University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-Hong Zhong, PhD

CONTACT

07715301253; zhongjianhong66@163.com

Zhong

CONTACT

zhongjianhong66@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the finial analysis is published in a journal.
• Access Criteria: Ask the corresponding author: zhongjianhong66@163.com

Locations

CN (1)