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

November 20, 2014 updated by: Jia Fan

Investigator Initiated Study of Thymosin in HBV-related HCC

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • ZADAXIN
Drug: nucleoside analog (suggest to use entecavir)
Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-free Survival
Time Frame: 2-year
2-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 1-year
1-year
Recurrence-free Survival (RFS)
Time Frame: 1-year
1-year
Overall survival (OS)
Time Frame: 2-year
2-year
Mean recurrence time
Time Frame: up to 2 years
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)
tumor sample will be collected at baseline and when relapse
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.
2-year
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.
2-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jia Fan

Collaborators

SciClone Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 30, 2014

First Posted (Estimate)

November 2, 2014

Study Record Updates

Last Update Posted (Estimate)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZDX-2014-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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