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Trial · Interventional

Status unknownPhase 4Registry data

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

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
360 participants (estimated)
Sponsor
Jia Fan · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
Jan 2015
Primary completion
Jun 2018 (estimated)
Completion
Oct 2018 (estimated)
First posted
3 Nov 2014 (estimated)
Last update posted
21 Nov 2014 (estimated)
Conditions
Curable Hepatitis B Virus-Related Hepatocellular Carcinoma

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016201720182019
  1. Ph 4

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

    NCT02281266

    Jan 2015 to est. Oct 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • curative resectionProcedure
  • thymalfasinDrug
  • nucleoside analog (suggest to use entecavir)Drug

Arms2

  • Experimental

    treatment (T)

    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.

  • Other

    control (C)

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Recurrence-free Survival

    Time frame · 2-year

Secondary outcomes(7)
  1. Recurrence-free Survival (RFS)

    Time frame · 1-year

  2. Overall survival (OS)

    Time frame · 1-year

  3. Overall survival (OS)

    Time frame · 2-year

  4. Mean recurrence time

    Time frame · up to 2 years

  5. Tumor sample immune cell counts

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

    Registry description

    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)

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

    Time frame · 2-year

    Registry description

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

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

    Time frame · 2-year

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2015

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.

Qiu et al. 2015Expert opinion on biological therapycited by 11

PMID 26094695DOI 10.1517/14712598.2015.1039979PUB-26094695

Rights unknown
Source link

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGe 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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