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

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jia Fan
• Collaborator: SciClone Pharmaceuticals
• Treatments: Entecavir; Thymalfasin

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.