Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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sorafenib group

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

Group Type EXPERIMENTAL

Sorafenib

Intervention Type DRUG

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

TACE group

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

Group Type EXPERIMENTAL

TACE

Intervention Type PROCEDURE

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

control group

Control group patients will not accept any intervention,except necessary supportive treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sorafenib

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

Intervention Type DRUG

TACE

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No