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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03843229
• Other study ID #: PJ-KS-KY-2018-07(x)
• Status: Recruiting
• Phase: Phase 4
• Start date: January 27, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: February 2019
• Source: The First Affiliated Hospital of Dalian Medical University
• Contact: Xiaonan Cui, MD,PhD
• Phone: +8618098876725
• Email: cxn23[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor size		the 8th week after TACE operation
Secondary	the number of CD4+T cell,CD8+T cell in blood		the 8th week after TACE operation
Secondary	Interleukin(IL)-2,Interleukin(IL)-4,Interleukin(IL)-6,tumor necrosis factor(TNF)-a,interferon(INF)-? in blood		the 8th week after TACE operation