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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.

Condition or disease Intervention/treatment Phase
Curable Hepatitis B Virus-Related Hepatocellular Carcinoma Procedure: curative resection Drug: thymalfasin Drug: nucleoside analog (suggest to use entecavir) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigator Initiated Study of Thymosin in HBV-related HCC
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Procedure: curative resection
Drug: thymalfasin
1.6mg twice a week, 12 months
Other Name: ZADAXIN

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.

Procedure: curative resection
Drug: nucleoside analog (suggest to use entecavir)



Primary Outcome Measures :
  1. Recurrence-free Survival [ Time Frame: 2-year ]

Secondary Outcome Measures :
  1. Recurrence-free Survival (RFS) [ Time Frame: 1-year ]
  2. Overall survival (OS) [ Time Frame: 1-year ]
  3. Overall survival (OS) [ Time Frame: 2-year ]
  4. Mean recurrence time [ Time Frame: up to 2 years ]
  5. 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)

  6. 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.

  7. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281266


Locations
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China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Jia Fan
SciClone Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jia Fan, Prof., Fudan University
ClinicalTrials.gov Identifier: NCT02281266    
Other Study ID Numbers: ZDX-2014-05
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: November 21, 2014
Last Verified: November 2014
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Carcinoma
Carcinoma, Hepatocellular
Hepatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Thymalfasin
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs