Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 27, 2019
CompletedFirst Submitted
Initial submission to the registry
February 10, 2019
CompletedFirst Posted
Study publicly available on registry
February 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedFebruary 18, 2019
February 1, 2019
1.6 years
February 10, 2019
February 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
tumor size
the 8th week after TACE operation
Secondary Outcomes (2)
the number of CD4+T cell,CD8+T cell in blood
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
the 8th week after TACE operation
Study Arms (2)
treatment group
EXPERIMENTALThe 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.
control group
OTHERThe control group only receives Transarterial Chemoembolization (TACE).
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaonan Cui, MD,PhD
The First Affiliated Hospital of Dalian Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2019
First Posted
February 18, 2019
Study Start
January 27, 2019
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
February 18, 2019
Record last verified: 2019-02