thymalfasin adjuvant therapy in hepatitis b virus (hbv)-related hepatocellular carcinoma (hcc) after curative resection

Conditions: Curable Hepatitis B Virus-Related Hepatocellular Carcinoma

Summary: 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.