Clinical trial · Interventional
Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection
Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial
NCT02537158CI-TRIAL-00021359unknownN/AClinicalTrials.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 a prospective non-randomized controlled study. The purpose of this study is to evaluate the validity and safety of sorafenib and transcatheter arterial chemoembolization (TACE) for microvascular invasion (MVI) in hepatocellular carcinoma (HCC) patients after radical surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib | Drug | Sorafenib | ALIAS |
| TACE | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- sorafenib group
- description
- sorafenib group patients will accept sorafenib therapy for one year(400 mg bid,orally).
- interventionNames
- Drug: Sorafenib
- type
- EXPERIMENTAL
- label
- TACE group
- description
- TACE group patients will accept TACE therapy once at a month after resection.
- interventionNames
- Procedure: TACE
- type
- NO_INTERVENTION
- label
- control group
- description
- Control group patients will not accept any intervention,except necessary supportive treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 18-75 years of age; * The liver tumor has been radically resected; * Postoperative pathology proved to be hepatocellular carcinoma with negative margin and microvascular invasion; * Imaging evaluations(CT/MRI) were performed at 1 month after the resection and no area of enhancement was seen; * Child-Pugh A; * Eastern Cooperative Oncology Group(ECOG) body condition score (PS) 0-1; * Then patients understand and voluntarily signed a written informed consent; Exclusion Criteria: * Recurrent HCC; * pathology-proved multifocal HCC or HCC with satellite nodules; * Tumor thrombus in portal vein or inferior vena cava trunk; * Patients with extrahepatic metastasis found by radiologic or pathologic examination; * severe dysfunction of the heart, kidney, or other organs.The patients cannot tolerate TACE or sorafenib after general assessment of the situation; * Enrolled in other clinical study at the same time; * Previously treated with other antitumor treatments except the resection; * The researchers believe that the patient does not fit this study; * Pregnant or lactating women.
References
Publications (6)
- BACKGROUNDRodriguez-Peralvarez M, Luong TV, Andreana L, Meyer T, Dhillon AP, Burroughs AK. A systematic review of microvascular invasion in hepatocellular carcinoma: diagnostic and prognostic variability. Ann Surg Oncol. 2013 Jan;20(1):325-39. doi: 10.1245/s10434-012-2513-1. Epub 2012 Nov 13. PMID 23149850
- BACKGROUNDSumie S, Nakashima O, Okuda K, Kuromatsu R, Kawaguchi A, Nakano M, Satani M, Yamada S, Okamura S, Hori M, Kakuma T, Torimura T, Sata M. The significance of classifying microvascular invasion in patients with hepatocellular carcinoma. Ann Surg Oncol. 2014 Mar;21(3):1002-9. doi: 10.1245/s10434-013-3376-9. Epub 2013 Nov 20. PMID 24254204
- BACKGROUNDRoayaie S, Blume IN, Thung SN, Guido M, Fiel MI, Hiotis S, Labow DM, Llovet JM, Schwartz ME. A system of classifying microvascular invasion to predict outcome after resection in patients with hepatocellular carcinoma. Gastroenterology. 2009 Sep;137(3):850-5. doi: 10.1053/j.gastro.2009.06.003. Epub 2009 Jun 12. PMID 19524573
- BACKGROUNDZhu YB, Xu X, Zheng SS. [Association of microvascular invasion with recurrence and prognosis of patients with small hepatocellular carcinoma undergoing liver transplantation]. Zhejiang Da Xue Xue Bao Yi Xue Ban. 2014 Nov;43(6):658-63. doi: 10.3785/j.issn.1008-9292.2014.11.004. Chinese. PMID 25644564
- BACKGROUNDShirabe K, Toshima T, Kimura K, Yamashita Y, Ikeda T, Ikegami T, Yoshizumi T, Abe K, Aishima S, Maehara Y. New scoring system for prediction of microvascular invasion in patients with hepatocellular carcinoma. Liver Int. 2014 Jul;34(6):937-41. doi: 10.1111/liv.12459. Epub 2014 Jan 24. PMID 24393295
- BACKGROUNDMeniconi RL, Komatsu S, Perdigao F, Boelle PY, Soubrane O, Scatton O. Recurrent hepatocellular carcinoma: a Western strategy that emphasizes the impact of pathologic profile of the first resection. Surgery. 2015 Mar;157(3):454-62. doi: 10.1016/j.surg.2014.10.011. Epub 2014 Nov 6.