NCT07417397RecruitingPhase 3
Adjuvant TACE in HCC With High-risk Recurrence Factors
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
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 442 (estimated)
- First submitted
- 11 Feb 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Guangxi Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07417397
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 442
- From 1 Feb 2026 to the primary completion date, 31 Dec 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- diagnosis of other malignancies within the 5 years prior to enrollment;
- participants who have experienced severe infections within 4 weeks before the first dose, or who have previously received systemic anti-tumor therapy;
Other illness
- 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;
Other
- absence of pathological confirmation of HCC;
- pregnant or lactating women are ineligible for participation;
- participants who are unable to comply with the treatment regimen or complete the follow-up requirements.
Who the study is looking for
- 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).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.