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Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection

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ClinicalTrials.gov Identifier: NCT02281266
Recruitment Status : Unknown
Verified November 2014 by Jia Fan, Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2014
Last Update Posted : November 21, 2014
Sponsor:
Collaborator:
SciClone Pharmaceuticals
Information provided by (Responsible Party):
Jia Fan, Fudan University

Tracking Information
First Submitted Date  ICMJE October 15, 2014
First Posted Date  ICMJE November 2, 2014
Last Update Posted Date November 21, 2014
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
Recurrence-free Survival [ Time Frame: 2-year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
Official Title  ICMJE Investigator Initiated Study of Thymosin in HBV-related HCC
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Curable Hepatitis B Virus-Related Hepatocellular Carcinoma
Intervention  ICMJE
  • Procedure: curative resection
  • Drug: thymalfasin
    1.6mg twice a week, 12 months
    Other Name: ZADAXIN
  • Drug: nucleoside analog (suggest to use entecavir)
Study Arms  ICMJE
  • Experimental: treatment (T)

    The patients of treatment arm will be administered subcutaneously Thymalfasin at dose of 1.6mg twice a week for 12 months after curative resection, followed by 12 months observation.

    Nucleoside analog plan to give to HBV DNA positive patients.

    Interventions:
    • Procedure: curative resection
    • Drug: thymalfasin
    • Drug: nucleoside analog (suggest to use entecavir)
  • control (C)

    The patients of control arm will be followed up for 2 years periodically after curative resection, without the investigational product (Thymalfasin) therapy.

    Nucleoside analog plan to give to HBV DNA positive patients.

    Interventions:
    • Procedure: curative resection
    • Drug: nucleoside analog (suggest to use entecavir)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 30, 2014)
360
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02281266
Other Study ID Numbers  ICMJE ZDX-2014-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jia Fan, Fudan University
Study Sponsor  ICMJE Jia Fan
Collaborators  ICMJE SciClone Pharmaceuticals
Investigators  ICMJE Not Provided
PRS Account Fudan University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP