Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
NCT ID: NCT02281266
Last Updated: 2014-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
360 participants
INTERVENTIONAL
2015-01-31
2018-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
curative resection
thymalfasin
1.6mg twice a week, 12 months
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.
curative resection
nucleoside analog (suggest to use entecavir)
Interventions
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curative resection
thymalfasin
1.6mg twice a week, 12 months
nucleoside analog (suggest to use entecavir)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Jia Fan
OTHER
Responsible Party
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Jia Fan
Prof.
Locations
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Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Ge S, Huang D. Systemic therapies for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):352-62. doi: 10.5582/ddt.2015.01047.
Qiu SJ, Zhou ZG, Shen F, Li AJ, Chen MS, Ying MG, Chen Z, Zhang YX, Sun HC, Fan J. A multicenter, randomized, observation-controlled clinical trial to evaluate the efficacy and safety of thymalfasin adjuvant therapy in patients with HBV-related HCC after curative resection - first announcement of the protocol. Expert Opin Biol Ther. 2015;15 Suppl 1:S133-7. doi: 10.1517/14712598.2015.1039979. Epub 2015 Jun 22.
Other Identifiers
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ZDX-2014-05
Identifier Type: -
Identifier Source: org_study_id