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

The First Affiliated Hospital of Dalian Medical University

Status and phase: Unknown; Phase 4

Conditions: Liver Cancer

Treatments: Drug: cinobufacini tablet; Procedure: Transarterial Chemoembolization(TACE); Drug: Cinobufacini injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03843229

PJ-KS-KY-2018-07(x)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

treatment group

Experimental group

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.

Treatment:

Drug: cinobufacini tablet

Procedure: Transarterial Chemoembolization(TACE)

Drug: Cinobufacini injection

control group

Other group

Description:

The control group only receives Transarterial Chemoembolization (TACE).

Treatment:

Procedure: Transarterial Chemoembolization(TACE)