ClinicalTrials.gg
RecruitingNCT07417397Updated Feb 18, 2026

Adjuvant TACE in HCC With High-risk Recurrence Factors

A Phase 3 interventional study of Adjuvant transarterial chemoembolization and Intensive follow-up in Hepatocellular Carcinoma, Adjuvant and Transarterial Chemoembolization, sponsored by Guangxi Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by Guangxi Medical University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.

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Phase
Phase 3
Study type
Interventional
Enrollment
442
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University — 6 open to participants now, 7 under way, 4 of them phase 3. Carcinoma, Hepatocellular · Guangxi Medical University.

Planned enrollment
3rd of 29
442 · median 100
Started
2026
the only one that year
Phase 3
13 of 34
3 open now
Registered
33rd of 34
by date

Among the 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University, this one is the 3rd largest by planned enrollment of the 29 interventional ones that give a count, is the only one that started in 2026, is one of 13 in phase 3, and was the 33rd registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

6 of the 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years to 70 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 34 studies in Carcinoma, Hepatocellular by Guangxi Medical University, or all of them as a file.
02

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.

03

Conditions studied

  • Hepatocellular Carcinoma
  • Adjuvant
  • Transarterial Chemoembolization

Keywords

  • transarterial chemoembolization
  • hepatocellular carcinoma
  • adjuvant
04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • performance status (ECOG PS) 0-1 at enrollment;
  • 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 >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 confirmed by postoperative pathology; positive or narrow surgical margin; and Edmondson grade Ⅲ-Ⅳ differentiation).

Exclusion criteria

Exclusion Criteria:

  • absence of pathological confirmation of HCC;
  • diagnosis of other 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, disease, or long-term 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
442 participants (estimated)

Study 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.

    Drug: Adjuvant transarterial chemoembolization

  • Active comparator
    Intensive follow-up

    The patients will receive intensive follow-up.

    Other: Intensive follow-up

Interventions

  • DrugAdjuvant 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.

  • OtherIntensive follow-up

    The patients will receive intensive follow-up.

06

What researchers measure

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.

    Time frame: two years

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Outcome data.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

Time frame: After the finial analysis is published in a journal.

Access criteria: Ask the corresponding author: zhongjianhong66@163.com

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2026 (actual). Primary completion is estimated for Dec 2029, 46 months after the start.

Of 86 non-industry phase 3 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 49 and three quarters within 109. This study's planned 46 months is below that.

Counting every sponsor, half of 138 studies reached it within 56 months; a quarter within 43 and three quarters within 83.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2026
First posted
Feb 18, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Feb 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07417397
Lead sponsor
Guangxi Medical University
Responsible party
Jian-Hong Zhong (Professor, Cancer Hospital of Guangxi Medical University) — Principal investigator
First posted
Feb 18, 2026
Start date
Feb 1, 2026
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 18, 2026

Study contacts

Jian-Hong Zhong, PhD
Contact
zhongjianhong66@163.com
07715301253
Jian-Hong Zhong
principal investigator · Guangxi Medical University Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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