Sorafenib and TACE as Adjuvant Therapy for MVI in HCC Patients After Radical Resection
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hepatocellular-carcinoma
Started Aug 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 29, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedMarch 15, 2016
March 1, 2016
2.9 years
August 29, 2015
March 13, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence-free survival
36 month
Secondary Outcomes (1)
overall survival
36 month
Study Arms (3)
sorafenib group
EXPERIMENTALsorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
TACE group
EXPERIMENTALTACE group patients will accept TACE therapy once at a month after resection.
control group
NO INTERVENTIONControl group patients will not accept any intervention,except necessary supportive treatment.
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cancer Hospital and Institute, Chinese Academy of Medical Sciences
Beijing, 100026, China
Related Publications (6)
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.
PMID: 23149850BACKGROUNDSumie 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.
PMID: 24254204BACKGROUNDRoayaie 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.
PMID: 19524573BACKGROUNDZhu 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.
PMID: 25644564BACKGROUNDShirabe 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.
PMID: 24393295BACKGROUNDMeniconi 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.
PMID: 25633732BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Xinyu Bi, Doctor
Cancer Hospital and Institute, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Xinyu Bi
Study Record Dates
First Submitted
August 29, 2015
First Posted
September 1, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
March 15, 2016
Record last verified: 2016-03