Hepatocellular Carcinoma
Conditions
Brief summary
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.
Interventions
PROCEDURETACE
TACE is performed one month after resection.
DRUGSorafenib
Sorafenib is submitted one month after resection.
DRUGTACE plus sorafenib
TACE plus sorafenib will be submitted one month after resection.
OTHERempty control
This group will not receive adjuvant therapy.
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivals | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Hospital mortality | 30-day |
| Recurrence rates | 1 years |
Countries
China
Outcome results
None listed