Adjuvant TACE after curative liver cancer surgery for patients with high-risk recurrence features

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares adjuvant transarterial chemoembolization (TACE) to intensive follow-up in patients who have undergone curative hepatectomy for hepatocellular carcinoma and have at least one high-risk recurrence factor. Participants must have ECOG 0-1, Child-Pugh A or B7, pathologically confirmed HCC, no prior systemic therapy, and undergo hepatic angiography 4–8 weeks after surgery to confirm no visible intrahepatic tumor staining before randomization. The primary outcome is recurrence-free survival, with follow-up visits and imaging per protocol to detect intrahepatic recurrence. The trial is being conducted at Guangxi Medical University Cancer Hospital and focuses on whether postoperative TACE can reduce the high rate of early recurrence seen after surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Where it's running

• Guangxi Medical University Cancer Hospital
  Nanning, China Recruiting

Study contacts

• Principal investigator: Jian-Hong Zhong — Guangxi Medical University Cancer Hospital
• Study coordinator: Jian-Hong Zhong, PhD
• Email: zhongjianhong66@163.com
• Phone: 07715301253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.