PROCEDURE
Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
Status
Unknown
Phase
Phase 4
Enrollment
360
Locations
1
Results
Not posted
Publications
2
Study summary
What the protocol is testing.
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.
Full 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
Treatment arms and agents.
DRUG
thymalfasin
1.6mg twice a week, 12 months
DRUG
nucleoside analog (suggest to use entecavir)
Timeline
From registration to results.
First posted
Nov 3, 2014
Study start
Jan 2015
Primary completion
Jun 2018
Study completion
Oct 2018
Results posted
Not reported
Registry updated
Nov 21, 2014
Outcomes
What the study measures.
Primary outcomes
Recurrence-free Survival
Time frame · 2-year
Secondary outcomes
Recurrence-free Survival (RFS)
Time frame · 1-year
Overall survival (OS)
Time frame · 1-year
Overall survival (OS)
Time frame · 2-year
Mean recurrence time
Time frame · up to 2 years
Tumor sample immune cell counts
Time frame · 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)
incidence and types of Adverse Events (AE) and serious adverse event (SAE)
Time frame · 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
Time frame · 2-year
The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- 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.
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Publications
Results and literature.
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