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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
360
1.6mg twice a week, 12 months
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Recurrence-free Survival
Time frame: 2-year
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
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)
Time frame: tumor sample will be collected at baseline and when relapse
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.
Time frame: 2-year
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.
Time frame: 2-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.