Clinical trial · Interventional
Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection
Investigator Initiated Study of Thymosin in HBV-related HCC
NCT02281266CI-TRIAL-00016132unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Curable Hepatitis B Virus-Related Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curative resection | Procedure | — | UNRESOLVED |
| nucleoside analog (suggest to use entecavir) | Drug | — | UNRESOLVED |
| thymalfasin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- 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. Nucleoside 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. Nucleoside analog plan to give to HBV DNA positive patients.
- interventionNames
- Procedure: curative resection
- Drug: nucleoside analog (suggest to use entecavir)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (2)
- 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
- DERIVEDQiu 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. PMID 26094695