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Trial record 227 of 517 for:    hepatitis b | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2014 by Fudan University
Sponsor:
Collaborator:
SciClone Pharmaceuticals
Information provided by (Responsible Party):
Jia Fan, Fudan University
ClinicalTrials.gov Identifier:
NCT02281266
First received: October 15, 2014
Last updated: November 20, 2014
Last verified: November 2014
  Purpose
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigator Initiated Study of Thymosin in HBV-related HCC

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • Recurrence-free Survival [ Time Frame: 2-year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recurrence-free Survival (RFS) [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: 2-year ] [ Designated as safety issue: No ]
  • Mean recurrence time [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
  • Tumor sample immune cell counts [ Time Frame: tumor sample will be collected at baseline and when relapse ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated.


Estimated Enrollment: 360
Study Start Date: January 2015
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02281266

Locations
China, Shanghai
Zhongshan Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Jia Fan
SciClone Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jia Fan, Prof., Fudan University
ClinicalTrials.gov Identifier: NCT02281266     History of Changes
Other Study ID Numbers: ZDX-2014-05 
Study First Received: October 15, 2014
Last Updated: November 20, 2014
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Carcinoma
Carcinoma, Hepatocellular
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepadnaviridae Infections
DNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Entecavir
Thymalfasin
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016