Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-02-11 @ 9:11 PM
Study NCT ID:
NCT02281266
Status:
UNKNOWN
Last Update Posted:
2014-11-21
First Post:
2014-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077596', 'term': 'Thymalfasin'}, {'id': 'D009705', 'term': 'Nucleosides'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-20', 'studyFirstSubmitDate': '2014-10-15', 'studyFirstSubmitQcDate': '2014-10-30', 'lastUpdatePostDateStruct': {'date': '2014-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence-free Survival', 'timeFrame': '2-year'}], 'secondaryOutcomes': [{'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', '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)'}, {'measure': 'incidence and types of Adverse Events (AE) and serious adverse event (SAE)', 'timeFrame': '2-year', 'description': 'AE and SAE will be reported. The number of patients with AE and the number of patients with SAE will be calculated.'}, {'measure': 'number of patients with abnormal laboratory value, vital signs and ECG result', 'timeFrame': '2-year', 'description': 'The number of patients with abnormal laboratory value, vital signs and ECG result during the study will also be calculated.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Curable Hepatitis B Virus-Related Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '26632544', 'type': 'DERIVED', '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.'}, {'pmid': '26094695', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria during perioperative period\n\n* Male or female patients with age between 18-70 years.\n* Life expectance ≥ 3 months.\n* Diagnosis of Hepatocellular Carcinoma confirmed by Histological or Cytological examination.\n* Hepatitis B history with current HBsAg positive and/or HBV DNA positive\n* Will undergo hepatic curative resection.\n* 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\n* East Cooperative Oncology Group performance score of 0-2\n* Normal liver function or sufficient liver function, defined as Chlid's-Pugh A\n\nInclusion criteria at baseline post-operation (4weeks ± 7days post-operation)\n\n* No documented evidence of disease recurrence with computed tomography (CT) scan and CT angiography.\n* Grade A of Chlid's-Pugh score\n* 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\n* signed informed consent\n\nExclusion Criteria:\n\n* 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.\n* Taking the hepatotoxic drug or immunosuppressant drug.\n* Invasion of portal vascular and its first branch, hepatic duct and its first branch, inferior vena cava and hepatic vein.\n* Organ transplant recipient.\n* Extra-hepatic organs and lymph node metastasis.\n* 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.\n* 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\n* Known human immune deficiency virus (HIV) infection\n* hepatitis C virus (HCV) infection\n* History of stroke or transient ischemic attack within 6 months prior to randomization\n* Active or untreated central nervous system (CNS) metastasis\n* History of clinically significant drug or alcohol abuse\n* Prior treatment with immunomodulator (e.g. interferon, Thymalfasin) or traditional Chinese medicine within 30 days prior to randomization\n* Know postoperative complications (e.g. infection, bleeding, bile leak) at baseline\n* Known allergic reaction to the investigational product and its excipient.\n* Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.\n* The investigator considers the subject, for any reason, to be unacceptable for study participation.\n* Participating in other clinical trials of the drug or medical device within 30 days prior to randomization."}, 'identificationModule': {'nctId': 'NCT02281266', 'briefTitle': 'Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Investigator Initiated Study of Thymosin in HBV-related HCC', 'orgStudyIdInfo': {'id': 'ZDX-2014-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment (T)', 'description': '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.\n\nNucleoside analog plan to give to HBV DNA positive patients.', 'interventionNames': ['Procedure: curative resection', 'Drug: thymalfasin', 'Drug: nucleoside analog (suggest to use entecavir)']}, {'type': 'OTHER', 'label': 'control (C)', 'description': 'The patients of control arm will be followed up for 2 years periodically after curative resection, without the investigational product (Thymalfasin) therapy.\n\nNucleoside analog plan to give to HBV DNA positive patients.', 'interventionNames': ['Procedure: curative resection', 'Drug: nucleoside analog (suggest to use entecavir)']}], 'interventions': [{'name': 'curative resection', 'type': 'PROCEDURE', 'armGroupLabels': ['control (C)', 'treatment (T)']}, {'name': 'thymalfasin', 'type': 'DRUG', 'otherNames': ['ZADAXIN'], 'description': '1.6mg twice a week, 12 months', 'armGroupLabels': ['treatment (T)']}, {'name': 'nucleoside analog (suggest to use entecavir)', 'type': 'DRUG', 'armGroupLabels': ['control (C)', 'treatment (T)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jia Fan', 'class': 'OTHER'}, 'collaborators': [{'name': 'SciClone Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Jia Fan', 'investigatorAffiliation': 'Fudan University'}}}}