Status:
UNKNOWN
Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
Lead Sponsor:
Jia Fan
Collaborating Sponsors:
SciClone Pharmaceuticals
Conditions:
Curable Hepatitis B Virus-Related Hepatocellular Carcinoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 Resec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2018
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02281266
Start Date
January 1 2015
End Date
October 1 2018
Last Update
November 21 2014
Active Locations (1)
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1
Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200032