Curable Hepatitis B Virus-Related Hepatocellular Carcinoma Clinical Trial
Official title:
Investigator Initiated Study of Thymosin in HBV-related HCC
| Verified date | November 2014 |
| Source | Fudan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Ethics Committee |
| Study type | Interventional |
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.
| Status | Not yet recruiting |
| Enrollment | 360 |
| Est. completion date | October 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Zhongshan Hospital | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Jia Fan | SciClone Pharmaceuticals |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence-free Survival | 2-year | No | |
| Secondary | Recurrence-free Survival (RFS) | 1-year | No | |
| Secondary | Overall survival (OS) | 1-year | No | |
| Secondary | Overall survival (OS) | 2-year | No | |
| Secondary | Mean recurrence time | up to 2 years | No | |
| Secondary | Tumor sample immune cell counts | 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), Mf count(CD68), dendritic cell(DC) count (CD1a,CD83), MVD(CD31) | tumor sample will be collected at baseline and when relapse | No |
| Secondary | incidence and types of Adverse Events (AE) and serious adverse event (SAE) | AE and SAE will be reported. The number of patients with AE and the number of patients with SAE will be calculated. | 2-year | Yes |
| Secondary | number of patients with abnormal laboratory value, vital signs and ECG result | The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated. | 2-year | Yes |