Curable Hepatitis B Virus-Related Hepatocellular Carcinoma
Conditions
Brief summary
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.
Detailed description
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.
Interventions
PROCEDUREcurative resection
DRUGthymalfasin
1.6mg twice a week, 12 months
DRUGnucleoside analog (suggest to use entecavir)
Sponsors
SciClone Pharmaceuticals
Jia Fan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence-free Survival | 2-year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 1-year | — |
| Mean recurrence time | up to 2 years | — |
| Recurrence-free Survival (RFS) | 1-year | — |
| incidence and types of Adverse Events (AE) and serious adverse event (SAE) | 2-year | AE and SAE will be reported. The number of patients with AE and the number of patients with SAE will be calculated. |
| number of patients with abnormal laboratory value, vital signs and ECG result | 2-year | The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated. |
| Tumor sample immune cell counts | tumor sample will be collected at baseline and when relapse | immune cell counts includes T cell counts(CD3, CD4, CD8), Treg count(FoxP3), Th17 cell count(IL-17), natural killer(NK) cell count(CD56), neutrophil count(CD66b), Mφ count(CD68), dendritic cell(DC) count (CD1a,CD83), MVD(CD31) |
Countries
China
Outcome results
None listed