Clinical trial · Interventional
Anlotinib Combined With TACE in Hepatocellular Carcinoma Patients at High Risk of Post Surgery Recurrence
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
NCT04213118CI-TRIAL-00063253ALTER-H-004unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A single-arm, open-label clinical trial to assess the effects and safety of anlotinib hydrochloride combined with transcatheter arterial chemoembolization (TACE) in hepatocellular carcinoma(HCC) patients at high risk of post surgery recurrence.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anlotinib | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| TACE | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib Hydrochloride | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Administration anlotinib and it should be continued until relapse of HCC or intolerable toxicity or patients withdrawal of consent.
- interventionNames
- Drug: Anlotinib Hydrochloride
- Procedure: TACE
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- From randomization to recurrence of HCC or death (up to 1year)
- description
- The period from resection surgery to recurrence of HCC
Secondary outcomes (3)
- measure
- 1-year DFS Rate
- timeFrame
- From randomization to recurrence of HCC or death (up to 1year)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients participate in the study voluntarily and sign informed consent with good compliance. * After hepatectomy, satisfy any of the following recurrence factors was assessed:≥5 cm and \< 10 cm of tumor diameter; tumor number≥3; tumor microvascular invasion grade M1; portal vein carcinoma thrombus resection(Ⅰ、Ⅱ). * Histological or cytological confirmation of hepatocellular carcinoma, or at least two imaging tests with hepatocellular carcinoma characteristics, or one imaging test with hepatocellular carcinoma characteristics and AFP \> 400μg/L. * TACE treatment (cTACE only) was completed within 1-2 months after hepatectomy. * ≥ 18 and ≤ 75 years of age. * ECOG performance status of 0-1. * liver function child-Pugh class A or B (≤7 points). * Except for hepatectomy, no previous tumor-related treatment was received, and the remaining liver was assessed to have good liver function. Exclusion Criteria: * Patients who have had or are currently complicated with other malignant tumors,or recurrent hepatocellular carcinoma (\>10 mm)in baseline data or in TACE. * Patients with absolute contraindications to TACE. * Patients with HCV infection. * Urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed. * Pregnant or lactating women. * Patients with mental illness.
References
Publications (1)
- DERIVEDWang Z, Zhang L, Zheng X, Zhang D, Yang X, Xu K, Tao J, Song X, Ma J, Wu Z. Adjuvant anlotinib plus TACE in hepatocellular carcinoma with postoperative high-risk recurrence: a single-arm, multi-center, phase II study. Clin Transl Oncol. 2026 Jun;28(6):2198-2207. doi: 10.1007/s12094-025-04160-0. Epub 2026 Jan 3. PMID 41484570