Adjuvant TACE in HCC With High-risk Recurrence Factors
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGuangxi Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Adjuvant transarterial chemoembolization
DrugFor 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
Other interventionThe patients will receive intensive follow-up.
Treatment groups
442 Participants
are divided into 2 treatment groupsGroup A: Adjuvant transarterial chemoembolizationExperimental treatment 1 intervention
Group B: Intensive follow-upActive comparator 1 intervention
Trial outcomes
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 yearsSponsors and contacts
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Guangxi Medical University
Lead sponsor
Cancer Hospital of Guangxi Medical University
Sponsor institution
Source ClinicalTrials.gov