Patient case: 45-year-old female with cervical cancer; genetic feature: ERBB2 (S310Y)

Clinical trial: Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection

Summary: 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.

Eligibility: 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.

Relevance to patient case: not relevant