Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection

Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.

Multi-center, Randomized, Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Thymalfasin Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma After Curative Resection.

Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria during perioperative period

* Male or female patients with age between 18-70 years.
* Life expectance ≥ 3 months.
* Diagnosis of Hepatocellular Carcinoma confirmed by Histological or Cytological examination.
* Hepatitis B history with current HBsAg positive and/or HBV DNA positive
* Will undergo hepatic curative resection.
* Tumor feature a. with cancer embolus b. a solitary nodule measuring between 3-8 cm or 2 nodule, a total combined measurement between 3-8 cm
* East Cooperative Oncology Group performance score of 0-2
* Normal liver function or sufficient liver function, defined as Chlid's-Pugh A

Inclusion criteria at baseline post-operation (4weeks ± 7days post-operation)

* No documented evidence of disease recurrence with computed tomography (CT) scan and CT angiography.
* Grade A of Chlid's-Pugh score
* hematological test white blood cell (WBC)\>3.5X109/L, red blood cell (RBC)\>30%, platelet count (PLT)\>50,000/Ul, neutrophil (NEU)\>1.0X109/L, Cr\<1.5 mg/dl
* signed informed consent

Exclusion Criteria:

* Any anti-cancer therapy, including liver transplant, transarterial Chemo-embolization (TACE), image-guided tumor ablation, radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy, etc. prior to the liver surgery procedure.
* Taking the hepatotoxic drug or immunosuppressant drug.
* Invasion of portal vascular and its first branch, hepatic duct and its first branch, inferior vena cava and hepatic vein.
* Organ transplant recipient.
* Extra-hepatic organs and lymph node metastasis.
* Uncontrolled Hypertension, unstable angina within 3 months, congestive heart failure (New York Heart Association (NYHA) Class II or greater), history of myocardial infarction within 6 months prior to randomization and severe arrhythmia need to be treated.
* History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
* Known human immune deficiency virus (HIV) infection
* hepatitis C virus (HCV) infection
* History of stroke or transient ischemic attack within 6 months prior to randomization
* Active or untreated central nervous system (CNS) metastasis
* History of clinically significant drug or alcohol abuse
* Prior treatment with immunomodulator (e.g. interferon, Thymalfasin) or traditional Chinese medicine within 30 days prior to randomization
* Know postoperative complications (e.g. infection, bleeding, bile leak) at baseline
* Known allergic reaction to the investigational product and its excipient.
* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
* The investigator considers the subject, for any reason, to be unacceptable for study participation.
* Participating in other clinical trials of the drug or medical device within 30 days prior to randomization.