Actively Recruiting
Adjuvant TACE in HCC With High-risk Recurrence Factors
Led by Guangxi Medical University · Updated on 2026-02-18
442
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Adjuvant TACE in HCC With High-risk Recurrence Factors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 at enrollment
- Child-Pugh class A or B7 (score 5-7)
- Have undergone radical hepatic resection at one of the study centers
- Histopathologically confirmed hepatocellular carcinoma
- Undergo hepatic angiography 4-8 weeks after surgery confirming no intrahepatic tumor staining
- No prior systemic anti-tumor therapy for hepatocellular carcinoma
- Adequate organ and bone marrow function
- Estimated life expectancy greater than 6 months
- Present with at least one high-risk factor for recurrence such as tumor rupture, tumor larger than 5 cm, multifocal tumors, microvascular invasion, portal vein invasion (Vp1/Vp2), lymph node metastasis, positive or narrow surgical margin, or Edmondson grade II-III differentiation
You will not qualify if you...
- No pathological confirmation of hepatocellular carcinoma
- Diagnosis of other malignancies within 5 years prior to enrollment
- History of hepatic encephalopathy, liver transplantation, symptomatic pleural effusion, ascites, or pericardial effusion after surgery
- History of drug allergy, active pulmonary tuberculosis, active syphilis infection, autoimmune disease, or long-term glucocorticoid use
- Severe infections within 4 weeks before first dose or previous systemic anti-tumor therapy
- Pregnant or lactating women
- Unable to comply with treatment or follow-up requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Guangxi Medical University Cancer Hospital
Nanning, China, 530021
Actively Recruiting
Research Team
J
Jian-Hong Zhong, PhD
CONTACT
Z
Zhong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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