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NCT02281266·Phase 4·INTERVENTIONAL

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

Status

Unknown

Phase

Phase 4

Enrollment

360

Locations

1

Results

Not posted

Publications

2

Study summary

What the protocol is testing.

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

Full 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.

Interventions

Treatment arms and agents.

PROCEDURE

curative resection

DRUG

thymalfasin

1.6mg twice a week, 12 months

DRUG

nucleoside analog (suggest to use entecavir)

Timeline

From registration to results.

  1. First posted

    Nov 3, 2014

  2. Study start

    Jan 2015

  3. Primary completion

    Jun 2018

  4. Study completion

    Oct 2018

  5. Results posted

    Not reported

  6. Registry updated

    Nov 21, 2014

Outcomes

What the study measures.

Primary outcomes

Recurrence-free Survival

Time frame · 2-year

Secondary outcomes

Recurrence-free Survival (RFS)

Time frame · 1-year

Overall survival (OS)

Time frame · 1-year

Overall survival (OS)

Time frame · 2-year

Mean recurrence time

Time frame · up to 2 years

Tumor sample immune cell counts

Time frame · tumor sample will be collected at baseline and when relapse

immune cell counts includes T cell counts(CD3, CD4, CD8), Treg count(FoxP3), Th17 cell count(IL-17), natural killer(NK) cell count(CD56), neutrophil count(CD66b), Mφ count(CD68), dendritic cell(DC) count (CD1a,CD83), MVD(CD31)

incidence and types of Adverse Events (AE) and serious adverse event (SAE)

Time frame · 2-year

AE and SAE will be reported. The number of patients with AE and the number of patients with SAE will be calculated.

number of patients with abnormal laboratory value, vital signs and ECG result

Time frame · 2-year

The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
70 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

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