Clinical trial NCT02537158: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: sorafenib
transcatheter arterial chemoembolization
hepatocellular carcinoma
microvascular invasion
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2015-09-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: recurrence-free survival
timeFrame: 36 month
Secondary outcomes:
measure: overall survival
timeFrame: 36 month
Other outcomes:
Locations:
city: Bei jing
country: China
facility: Cancer Hospital and Institute, Chinese Academy of Medical Sciences
Study officials:
affiliation: Cancer Hospital and Institute, Chinese Academy of Medical Sciences
name: Xinyu Bi, Doctor
role: STUDY_DIRECTOR
References:
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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.
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.