Clinical trial · Interventional
Efficacy Study of TACE to Treat Hepatocellular Carcinoma After Operation
Post-hepatectomy Adjuvant Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma Patients With Preoperative CTC Level ≥2: a Multicenter Randomized Controlled Trial in China
NCT02631499CI-TRIAL-00020284unknownPhase 4ClinicalTrials.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)
This study is designed to prospectively evaluate whether post-hepatectomy adjuvant transcatheter arterial chemoembolization (TACE) is effective in reducing early recurrence in HCC patients with preoperative CTC ≥2.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Neoplastic Cells, Circulating | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Epirubicin | Drug | Epirubicin | ALIAS |
| lipiodol | Drug | — | UNRESOLVED |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Adjuvant TACE
- description
- TACE will be performed 4-6 weeks after hepatectomy in patients with preoperative CTC ≥2 Epirubicin, lipiodol and gelatin sponge articles are used in TACE.
- interventionNames
- Procedure: TACE
- Drug: Epirubicin
- Drug: lipiodol
- type
- NO_INTERVENTION
- label
- Control
- description
- no interventions were assigned after hepatectomy
Primary outcomes (1)
- measure
- Early recurrence rates
- timeFrame
- 1 year after hepatectomy
- description
- Early recurrence was defined as any type of recurrence diagnosed within 1 year after hepatectomy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * HCC patients received curative hepatectomy with negative resection margin * Age from 18 to 75 * Child-Pugh class A * ASA class I to II * ECOG performance status Grade 0 or 1 * Preoperative CTC level ≥2 per 7.5 ml peripheral blood * No residual tumor revealed by hepatic arterial angiography 4-6 weeks after hepatectomy Exclusion Criteria: * Patients diagnosed with other types of malignancies besides HCC * Patients receiving concomitant local ablation or previous TACE * Main portal vein tumor thrombus extraction during hepatectomy * Hepatic arterial angiography before adjuvant TACE treatment reveals residual tumors. * Presence of extra-hepatic or lymphatic metastasis * Impaired liver function with either clinically detected ascites, hepatic encephalopathy, serum albumin \< 25g/L or bilirubin \> 50micromol/L * Renal impairment with creatinine \> 200micromol/L * Severe concurrent medical illness persisting \> 6 weeks after hepatectomy * History of other cancer * Hepatic artery anomaly making TACE not possible * Allergy to 5-Fluorouracil, Epirubicin or lipiodol * Pregnant woman * Informed consent not available
References
Publications (3)
- BACKGROUNDSun YF, Xu Y, Yang XR, Guo W, Zhang X, Qiu SJ, Shi RY, Hu B, Zhou J, Fan J. Circulating stem cell-like epithelial cell adhesion molecule-positive tumor cells indicate poor prognosis of hepatocellular carcinoma after curative resection. Hepatology. 2013 Apr;57(4):1458-68. doi: 10.1002/hep.26151. Epub 2013 Mar 4. PMID 23175471
- BACKGROUNDZhong C, Guo RP, Li JQ, Shi M, Wei W, Chen MS, Zhang YQ. A randomized controlled trial of hepatectomy with adjuvant transcatheter arterial chemoembolization versus hepatectomy alone for Stage III A hepatocellular carcinoma. J Cancer Res Clin Oncol. 2009 Oct;135(10):1437-45. doi: 10.1007/s00432-009-0588-2. Epub 2009 May 1. PMID 19408012
- BACKGROUNDRen ZG, Lin ZY, Xia JL, Ye SL, Ma ZC, Ye QH, Qin LX, Wu ZQ, Fan J, Tang ZY. Postoperative adjuvant arterial chemoembolization improves survival of hepatocellular carcinoma patients with risk factors for residual tumor: a retrospective control study. World J Gastroenterol. 2004 Oct 1;10(19):2791-4. doi: 10.3748/wjg.v10.i19.2791. PMID 15334671