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

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

This trial will see if giving TACE after curative liver surgery lowers the chance the cancer comes back in people who have high-risk features for recurrence.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 442 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Guangxi Medical University (other)
• Locations: 1 site (Nanning)
• Trial ID: NCT07417397 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with pathology-confirmed HCC who had curative hepatectomy, have at least one high-risk recurrence factor (for example tumor rupture, size >5 cm, multifocal disease, microvascular invasion, Vp1/Vp2 portal vein invasion, lymph node metastasis, positive/narrow margin, or Edmondson grade III–IV), have ECOG 0–1, Child-Pugh A or B7, adequate organ function, no prior systemic anti-tumor therapy, and an expected life expectancy >6 months.

Not a fit: Patients unlikely to benefit include those without high-risk features, those with poor liver function beyond Child-Pugh B7, those with recent or concurrent other malignancies within five years, or those who cannot undergo hepatic angiography or TACE.

Why it matters

Potential benefit: If successful, adjuvant TACE could reduce postoperative recurrence and improve long-term outcomes for high-risk HCC patients.

How similar studies have performed: Evidence to date is mixed: Chinese guidelines support adjuvant TACE while other regional guidelines do not, so prior studies have not provided a universally accepted benefit.

Eligibility criteria

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 this trial is running

Nanning

• 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

Conditions: Hepatocellular Carcinoma, Adjuvant, Transarterial Chemoembolization, transarterial chemoembolization, hepatocellular carcinoma, adjuvant