Trial reportClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2026
Adjuvant anlotinib plus TACE in hepatocellular carcinoma with postoperative high-risk recurrence: a single-arm, multi-center, phase II study.
Trial report in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04213118 (An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma), which is not on this map. Not yet cited in PubMed.
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An Open, Single Arm,Multicenter Clinical Trial of Anlotinib Combined With Transcatheter Arterial Chemoembolization for Adjuvant Therapy in Patients With High Risk of Recurrence After Resection of Advanced Hepatocellular Carcinoma
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10 authors.
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Abstract
purposeThis study assessed the efficacy and safety of anlotinib plus transcatheter arterial chemoembolization (TACE) as adjuvant therapy in hepatocellular carcinoma (HCC) at high-risk recurrence after resection.
methodsThis multi-center, single-arm, phase II study (ALTER-H004) enrolled patients with TACE-eligible HCC at high risk of recurrence after surgery. Three to five days after TACE, patients received 12 mg oral anlotinib once daily on days 1-14 every 3 weeks until recurrence, extrahepatic metastasis, or discontinuation was determined by investigators. Primary endpoint was disease-free survival (DFS).
resultsTwenty-nine patients were enrolled between April 2020 and August 2022. Median follow-up was 34.1 (IQR, 32.0-40.9) months. Of 27 with assessable efficacy, median DFS was 40.9 (95% CI, 11.4-70.3) months, with 1-, 2-, and 3-year DFS rates of 72.1% (95% CI, 50.2%-85.6%), 63.0% (95% CI, 40.7%-78.9%), and 56.7% (95% CI, 33.6%-74.5%), respectively. Four (14.8%) patients achieved DFS of > 36 months. Median time to recurrence (TTR) was 40.9 (95% CI, 11.4-70.3) months. Median OS was 43.3 (95% CI, not estimable [NE]-NE) months; OS rate was estimated as 92.1% (95% CI, 71.9%-98.0%) at 1 year, 87.9% (95% CI, 67.0%-96.0%) at 2 years, and 83.3% (95% CI, 61.2%-93.4%) at 3 years. Five (18.5%) patients experienced ≥ grade 3 treatment-related adverse events, including hypertension (7.4%), white blood cell decreased (7.4%), ascites (3.7%), and blood bilirubin increased (3.7%). No treatment-related deaths or serious AEs occurred.
conclusionThe study demonstrated manageable safety and promising clinical benefits of adjuvant anlotinib plus TACE for high-risk recurrent HCC following resection, indicating a potential intervention for this population. CLINICAL
trial registrationClinicalTrials.gov NCT04213118.
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