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

Primary Purpose

Hepatocellular Carcinoma

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Sorafenib

TACE

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring sorafenib, transcatheter arterial chemoembolization, hepatocellular carcinoma, microvascular invasion

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Cancer Hospital and Institute, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

sorafenib group

TACE group

control group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

recurrence-free survival

Secondary Outcome Measures

overall survival

Full Information

NCT ID

NCT02537158

First Posted

August 29, 2015

Last Updated

March 13, 2016

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02537158

Brief Title

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

Official Title

Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection:a Non-randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

sorafenib, transcatheter arterial chemoembolization, hepatocellular carcinoma, microvascular invasion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sorafenib group

Arm Type

Experimental

Arm Description

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

Arm Title

TACE group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sorafenib

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

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

Primary Outcome Measure Information:

Title

recurrence-free survival

Time Frame

36 month

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

36 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xinyu Bi, Doctor

Phone

86-13911792177

beexy1971@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xinyu Bi, Doctor

Organizational Affiliation

Cancer Hospital and Institute, Chinese Academy of Medical Sciences

Official's Role

Study Director

Facility Information:

Facility Name

Cancer Hospital and Institute, Chinese Academy of Medical Sciences

City

Bei jing

ZIP/Postal Code

100026

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xinyu Bi, Doctor

Phone

86-13911792177

beexy1971@163.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

23149850

Citation

Rodriguez-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.

Results Reference

background

PubMed Identifier

24254204

Citation

Sumie 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.

Results Reference

background

PubMed Identifier

19524573

Citation

Roayaie 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.

Results Reference

background

PubMed Identifier

25644564

Citation

Zhu 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.

Results Reference

background

PubMed Identifier

24393295

Citation

Shirabe 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.

Results Reference

background

PubMed Identifier

25633732

Citation

Meniconi 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.

Results Reference

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

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