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

Primary Purpose

Liver Cancer

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Cinobufacini injection
Transarterial Chemoembolization(TACE)
cinobufacini tablet
Sponsored by
The First Affiliated Hospital of Dalian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer focused on measuring Cinobufacini

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

treatment group

control group

Arm Description

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 Transarterial Chemoembolization (TACE).

Outcomes

Primary Outcome Measures

tumor size

Secondary Outcome Measures

the number of CD4+T cell,CD8+T cell in blood
Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6,tumor necrosis factor(TNF)-α，interferon(INF)-γ in blood

Full Information

First Posted
February 10, 2019
Last Updated
February 14, 2019
Sponsor
The First Affiliated Hospital of Dalian Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03843229
Brief Title
Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
Official Title
Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 27, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Dalian Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer
Keywords
Cinobufacini

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
The control group only receives Transarterial Chemoembolization (TACE).
Intervention Type
Drug
Intervention Name(s)
Cinobufacini injection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transarterial Chemoembolization(TACE)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
cinobufacini tablet
Intervention Description
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.
Primary Outcome Measure Information:
Title
tumor size
Time Frame
the 8th week after TACE operation
Secondary Outcome Measure Information:
Title
the number of CD4+T cell,CD8+T cell in blood
Time Frame
the 8th week after TACE operation
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaonan Cui, MD,PhD
Phone
+8618098876725
Email
cxn23@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Zhang
Phone
+8618098872580
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui, MD,PhD
Organizational Affiliation
The First Affiliated Hospital of Dalian Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaonan Cui
Phone
+8618098876725
Email
cxn23@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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