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

Jia Fan

Status and phase: Unknown; Phase 4

Conditions: Curable Hepatitis B Virus-Related Hepatocellular Carcinoma

Treatments: Drug: nucleoside analog (suggest to use entecavir); Drug: thymalfasin; Procedure: curative resection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02281266

ZDX-2014-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 2 patient groups

treatment (T)

Experimental group

Description:

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.

Treatment:

Drug: thymalfasin

Drug: nucleoside analog (suggest to use entecavir)

Procedure: curative resection

control (C)

Other group

Description:

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.

Treatment:

Drug: nucleoside analog (suggest to use entecavir)

Procedure: curative resection