Adjuvant Therapies for Patients With HCC and MVI

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis. Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.

Official Title
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Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: TACE
* Drug: Sorafenib
* Drug: TACE plus sorafenib
* Other: empty control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients Patients with microvascular invasion by histopathological examination of surgical samples Patients have Child-Pugh A or B liver function No previous neoadjuvant treatment No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings No malignancy other than HCC for 5 years prior to the initial HCC treatment Exclusion Criteria: History of cardiac disease Known history of human immunodeficiency virus (HIV) infection Known Central Nervous System tumors including metastatic brain disease History of organ allograft Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study Pregnant or breast-feeding patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE<br>Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection. | Procedure: TACE<br>* TACE is performed one month after resection.<br>* Other names: transarterial chemoembolization;Other: empty control<br>* This group will not receive adjuvant therapy.<br>|
| Active Comparator: sorafenib<br>Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection. | Drug: Sorafenib<br>* Sorafenib is submitted one month after resection.<br>|
| Other: TACE plus sorafenib<br>Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection. At the same time, TACE is performed two to four weeks after hepatic resection. | Drug: TACE plus sorafenib<br>* TACE plus sorafenib will be submitted one month after resection.<br>Other: empty control<br>* This group will not receive adjuvant therapy.<br>|
| No Intervention: empty control<br>This group patients will receive best supportive care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survivals |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality |  | 30-day | 
| Recurrence rates |  | 1 years |