Hepatocellular CarcinomaPhase 3NCT07417397
Adjuvant TACE in HCC With High-risk Recurrence Factors
A Phase 3 study testing Adjuvant transarterial chemoembolization and Intensive follow-up in people with Hepatocellular Carcinoma and Adjuvant, run by Guangxi Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Adjuvant, Transarterial Chemoembolization
- What is being tested?
- Adjuvant transarterial chemoembolization and Intensive follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 442 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Zhong contact
China1 site, 1 recruiting
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, 530021
Jian-Hong Zhong, PhD, 07715301253, zhongjianhong66@163.com
Jian-Hong Zhong, PhD
About this study
Official title: 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.
- Being tested
- Adjuvant transarterial chemoembolization, Intensive follow-up
- Keywords
- transarterial chemoembolization, hepatocellular carcinoma, adjuvant
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant transarterial chemoembolizationDrug
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-upOther
The patients will receive intensive follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Adjuvant transarterial chemoembolization |
| Intensive follow-up | Active comparator | The patients will receive intensive follow-up. Receives: Other: Intensive follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Feb 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Hong Zhong, Cancer Hospital of Guangxi Medical University
- Investigators
- Jian-Hong Zhong, Principal investigator, Guangxi Medical University Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417397
- Sponsor's protocol ID
- PREVENT-4
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome data.
Publications
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.
PubMed 40522319
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07417397
- Acronym / sponsor ID
- PREVENT-4
- Keywords
- transarterial chemoembolization, hepatocellular carcinoma, adjuvant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 442 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adjuvant transarterial chemoembolization | Experimental | Drug: Adjuvant transarterial chemoembolizationFor 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 | Active comparator | Other: Intensive follow-upThe patients will receive intensive follow-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjuvant transarterial chemoembolizationFor 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-upThe patients will receive intensive follow-up. | Other | Intensive follow-up |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 40522319Su 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.
- Individual participant dataSharing planned: Yes. Outcome data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhong contact
Jian-Hong Zhong principal investigator
Guangxi Medical University Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adjuvant transarterial chemoembolization and Intensive follow-up in people with Hepatocellular Carcinoma and Adjuvant, run by Guangxi Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian-Hong Zhong, PhD (07715301253, zhongjianhong66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.