Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT02281266
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02281266
Study Brief:
Protocol Section:
NCT02281266