Investigator Initiated Study of Thymosin in HBV-related HCC
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Recurrence-free Survival
研究概览
简要总结
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: curative resection (Procedure)
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.
干预措施: thymalfasin (Drug)
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.
干预措施: nucleoside analog (suggest to use entecavir) (Drug)
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.
干预措施: curative resection (Procedure)
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.
干预措施: nucleoside analog (suggest to use entecavir) (Drug)
结局指标
主要结局
Recurrence-free Survival
时间窗: 2-year
次要结局
- Recurrence-free Survival (RFS)(1-year)
- Overall survival (OS)(2-year)
- Mean recurrence time(up to 2 years)
- Tumor sample immune cell counts(tumor sample will be collected at baseline and when relapse)
- incidence and types of Adverse Events (AE) and serious adverse event (SAE)(2-year)
- number of patients with abnormal laboratory value, vital signs and ECG result(2-year)
研究者
Jia Fan
Prof.
Fudan University