Clinical trial NCT02281266: Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
Official title: Investigator Initiated Study of Thymosin in HBV-related HCC
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Curable Hepatitis B Virus-Related Hepatocellular Carcinoma
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: SciClone Pharmaceuticals
First posted: 2014-11-02
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Resection.

Eligibility 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.

Primary outcomes:
measure: Recurrence-free Survival
timeFrame: 2-year
Secondary outcomes:
measure: Recurrence-free Survival (RFS)
timeFrame: 1-year
measure: Overall survival (OS)
timeFrame: 1-year
measure: Overall survival (OS)
timeFrame: 2-year
measure: Mean recurrence time
timeFrame: up to 2 years
measure: Tumor sample immune cell counts
timeFrame: tumor sample will be collected at baseline and when relapse
measure: incidence and types of Adverse Events (AE) and serious adverse event (SAE)
timeFrame: 2-year
measure: number of patients with abnormal laboratory value, vital signs and ECG result
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
citation: Ge S, Huang D. Systemic therapies for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):352-62. doi: 10.5582/ddt.2015.01047.
citation: 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.