Curable Hepatitis B Virus-Related Hepatocellular CarcinomaPhase 4NCT02281266
Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
A Phase 4 study testing curative resection, thymalfasin and nucleoside analog (suggest to use entecavir) in people with Curable Hepatitis B Virus-Related Hepatocellular Carcinoma, run by Jia Fan at 1 site in China.
Trial summary
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Curable Hepatitis B Virus-Related Hepatocellular Carcinoma
- What is being tested?
- curative resection, thymalfasin and nucleoside analog (suggest to use entecavir)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Oct 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Investigator Initiated Study of Thymosin in HBV-related HCC
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.
Read the 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.
- Being tested
- curative resection, thymalfasin, nucleoside analog (suggest to use entecavir)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curative resectionProcedure or surgery
thymalfasinDrug
Also called ZADAXIN
1.6mg twice a week, 12 months
nucleoside analog (suggest to use entecavir)Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: curative resection; Drug: nucleoside analog (suggest to use entecavir) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival
Measured: 2-year
Secondary outcomes (7)
Recurrence-free Survival (RFS)
Measured: 1-year
Overall survival (OS)
Measured: 1-year
Overall survival (OS)
Measured: 2-year
Mean recurrence time
Measured: up to 2 years
Tumor sample immune cell counts
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)
Measured: tumor sample will be collected at baseline and when relapse
incidence and types of Adverse Events (AE) and serious adverse event (SAE)
AE and SAE will be reported. The number of patients with AE and the number of patients with SAE will be calculated.
Measured: 2-year
number of patients with abnormal laboratory value, vital signs and ECG result
The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated.
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJun 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Curable Hepatitis B Virus-Related Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia Fan
- Sponsor type
- University, hospital or other
- Collaborators
- SciClone Pharmaceuticals
- Responsible party
- Sponsor-investigator, Jia Fan, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281266
- Sponsor's protocol ID
- ZDX-2014-05
- Status last verified
- Nov 2014
- First submitted
- 15 Oct 2014
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ge S, Huang D. Systemic therapies for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):352-62. doi: 10.5582/ddt.2015.01047.
PubMed 26632544Qiu 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.
PubMed 26094695
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator Initiated Study of Thymosin in HBV-related HCC
- ClinicalTrials.gov ID
- NCT02281266
- Acronym / sponsor ID
- ZDX-2014-05
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Jia FanUniversity, hospital or other
- Collaborators
- SciClone Pharmaceuticals
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 3 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment (T) | Experimental | Procedure: curative resection, Drug: thymalfasin, Drug: nucleoside analog (suggest to use entecavir)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. |
| control (C) | Other | Procedure: curative resection, Drug: nucleoside analog (suggest to use entecavir)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curative resection | Procedure or surgery | control (C), treatment (T) |
| thymalfasinAlso: ZADAXIN1.6mg twice a week, 12 months | Drug | treatment (T) |
| nucleoside analog (suggest to use entecavir) | Drug | control (C), treatment (T) |
Primary outcome
Recurrence-free Survival
Time frame: 2-year
7 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
incidence and types of Adverse Events (AE) and serious adverse event (SAE)
Time frame: 2-year
number of patients with abnormal laboratory value, vital signs and ECG result
Time frame: 2-year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
- Derived from this study: PubMed 26632544Ge S, Huang D. Systemic therapies for hepatocellular carcinoma. Drug Discov Ther. 2015 Oct;9(5):352-62. doi: 10.5582/ddt.2015.01047.
- Derived from this study: PubMed 26094695Qiu 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing curative resection, thymalfasin and nucleoside analog (suggest to use entecavir) in people with Curable Hepatitis B Virus-Related Hepatocellular Carcinoma, run by Jia Fan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281266, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2014.