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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02537158
• Other study ID #: CH-GI-077
• Status: Recruiting
• Phase: N/A
• First received: August 29, 2015
• Last updated: March 13, 2016
• Start date: August 2015
• Est. completion date: July 2018

Study information

• Verified date: March 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Xinyu Bi, Doctor
• Phone: 86-13911792177
• Email: beexy1971[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

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

Locations

Country	Name	City	State
China	Cancer Hospital and Institute, Chinese Academy of Medical Sciences	Bei jing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (6)

Meniconi RL, Komatsu S, Perdigao F, Boëlle 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. — View 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. — View Citation

Rodríguez-Perálvarez 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. Review. — View 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. — View 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. — View 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. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence-free survival		36 month	Yes
Secondary	overall survival		36 month	Yes