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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537158
Recruitment Status : Unknown
Verified March 2016 by Xinyu Bi, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 1, 2015
Last Update Posted : March 15, 2016
Sponsor:
Information provided by (Responsible Party):
Xinyu Bi, Chinese Academy of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Sorafenib Procedure: TACE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial
Study Start Date : August 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arm Intervention/treatment
Experimental: sorafenib group
sorafenib group patients will accept sorafenib therapy for one year(400 mg bid,orally).
Drug: Sorafenib
sorafenib group patients will accept sorafenib therapy for one year(400 mg bid,orally).

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

No Intervention: control group
Control group patients will not accept any intervention,except necessary supportive treatment.



Primary Outcome Measures :
  1. recurrence-free survival [ Time Frame: 36 month ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 36 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537158


Contacts
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Contact: Xinyu Bi, Doctor 86-13911792177 beexy1971@163.com

Locations
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China
Cancer Hospital and Institute, Chinese Academy of Medical Sciences Recruiting
Bei jing, China, 100026
Contact: Xinyu Bi, Doctor    86-13911792177    beexy1971@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Director: Xinyu Bi, Doctor Cancer Hospital and Institute, Chinese Academy of Medical Sciences
Publications:

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Responsible Party: Xinyu Bi, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02537158    
Other Study ID Numbers: CH-GI-077
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: March 15, 2016
Last Verified: March 2016
Keywords provided by Xinyu Bi, Chinese Academy of Medical Sciences:
sorafenib
transcatheter arterial chemoembolization
hepatocellular carcinoma
microvascular invasion
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action