Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer

Overview

The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2020

Detailed Description

The clinical trail of Cinobufacini combined with TACE on primary liver cancer.The trail is randomized controled.Patients are diagnosed primary liver cancer based on pathology or cell biology.They are randomized into 2 groups:both groups receive TACE.The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months..The control group only receives TACE.Mainly to study Cinobufacini leads to the influence of the immunologic function after TACE.Immunological examination and Blood biochemistry evaluation include the number ratio、activity and function of immune cell,the immune cell marker(CD3、CD4、CD8,etc),tumor marker(CEA、AFP),etc.Clinical evaluation includes image data(CT/MRI),drug toxicities,quality of life(QOL),etc.

Interventions

  • Drug: Cinobufacini injection
    • The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
  • Procedure: Transarterial Chemoembolization(TACE)
    • TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible.
  • Drug: cinobufacini tablet
    • The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.

Arms, Groups and Cohorts

  • Experimental: treatment group
    • The treatment group receives Cinobufacini injection 20ml via hepatic artery during Transarterial Chemoembolization(TACE) operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
  • Other: control group
    • The control group only receives Transarterial Chemoembolization (TACE).

Clinical Trial Outcome Measures

Primary Measures

  • tumor size
    • Time Frame: the 8th week after TACE operation

Secondary Measures

  • the number of CD4+T cell,CD8+T cell in blood
    • Time Frame: the 8th week after TACE operation
  • Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6,tumor necrosis factor(TNF)-α,interferon(INF)-γ in blood
    • Time Frame: the 8th week after TACE operation

Participating in This Clinical Trial

Inclusion Criteria

  • Age:18-70 years. – male and female. – signed the informed consent form. – Diagnosis:Primary liver cancer diagnosed by imaging、cell and pathology report. – Eastern Cooperative Oncology Group (ECOG) :0-2;life expectancy more than 3 months. – Indication for TACE,no contraindication. – First time chemotherapy or at least 6 months after last chemotherapy and radiotherapy. – At least 8 weeks after last biotherapy. – Surgery:had not received transplantation surgery,at least 2 weeks after last major surgery. Exclusion Criteria:

  • Chemotherapy is contraindicated. – Have the primary disease can cause the neuropathy. – A history of other malignant tumor in recent 5 years. – Less than 6 months after last chemotherapy or radiotherapy. – Less than 8 months after last. – Cinobufacini allergy. – Had received transplantation surgery ,less than 2 weeks after last major surgery. – Other researchers think is not suitable for this clinical trail.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The First Affiliated Hospital of Dalian Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xiaonan Cui, MD,PhD, Principal Investigator, The First Affiliated Hospital of Dalian Medical University
  • Overall Contact(s)
    • Xiaonan Cui, MD,PhD, +8618098876725, cxn23@sina.com

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