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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02537158

Enrollment

Registered

2015-09-01

Start date

2015-08-31

Completion date

2018-07-31

Last updated

2016-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

sorafenib, transcatheter arterial chemoembolization, hepatocellular carcinoma, microvascular invasion

Brief summary

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.

Detailed description

HCC is the sixth most common malignancy worldwide.Selected patients with HCC are candidates for potentially curative therapy, such as hepatic resection and liver transplantation. Nevertheless,tumor recurrence is 70 % at 5 years after resection and 15-30 % after liver transplantation,leading to tumor-related death.MVI is currently one of the most critical factors predictive of HCC recurrence.There are no approved effective interventional measures to improve the outcome of this patients with MVI.The purpose of this study is to explore the validity and safety of sorafenib and TACE for MVI in HCC patients after radical resection.The candidates will be assigned to sorafenib group (about 30 cases),TACE group (about 30 patients) and control group (about 30 cases)，according to the willingness of the subject.All patients will be followed up for 3 years and Recurrence-free survival and overall survival will be recorded.

Interventions

DRUGSorafenib

sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).

PROCEDURETACE

TACE group patients will accept TACE therapy once at a month after resection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
recurrence-free survival	36 month

Secondary

Measure	Time frame
overall survival	36 month

Countries

China

Contacts

Primary ContactXinyu Bi, Doctor

beexy1971@163.com86-13911792177

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026