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

NCT02281266 | Unknown Phase 4 DMC

• 1 other identifier: ZDX-2014-05
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Curable Hepatitis B Virus-Related Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Recurrence-free Survival

  2-year

Secondary Outcomes (7)

• Recurrence-free Survival (RFS)

  1-year

• Overall survival (OS)

  1-year

• Overall survival (OS)

  2-year

• Mean recurrence time

  up to 2 years

• Tumor sample immune cell counts

  tumor sample will be collected at baseline and when relapse

Study Arms (2)

treatment (T)

EXPERIMENTAL

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; Drug: nucleoside analog (suggest to use entecavir)

control (C)

OTHER

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)

Interventions

curative resection PROCEDURE

control (C); treatment (T)

thymalfasin DRUG

1.6mg twice a week, 12 months

Also known as: ZADAXIN

treatment (T)

nucleoside analog (suggest to use entecavir) DRUG

control (C); treatment (T)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jia Fan: lead
• SciClone Pharmaceuticals: collaborator

Study Sites (1)

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (2)

• Ge S, Huang D. Systemic therapies for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):352-62. doi: 10.5582/ddt.2015.01047.

  PMID: 26632544 DERIVED

• 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.

  PMID: 26094695 DERIVED

MeSH Terms

Interventions

Thymalfasin; Nucleosides

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: November 3, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: October 1, 2018
• Last Updated: November 21, 2014

Record last verified: 2014-11

Locations

CN (1)