Liver CancerPhase 4NCT03843229
Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
A Phase 4 study testing Cinobufacini injection, Transarterial Chemoembolization(TACE) and cinobufacini tablet in people with Liver Cancer, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Cinobufacini injection, Transarterial Chemoembolization(TACE) and cinobufacini tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2019to 1 Sep 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Jian Zhang contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116000
Xiaonan Cui, +8618098876725, cxn23@sina.com
About this study
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.
Read the 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.
- Conditions
- Liver Cancer
- Being tested
- Cinobufacini injection, Transarterial Chemoembolization(TACE), cinobufacini tablet
- Keywords
- Cinobufacini
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinobufacini injectionDrug
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.
Transarterial Chemoembolization(TACE)Procedure or surgery
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.
cinobufacini tabletDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | 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. Receives: Drug: Cinobufacini injection; Procedure: Transarterial Chemoembolization(TACE); Drug: cinobufacini tablet |
| control group | Other | The control group only receives Transarterial Chemoembolization (TACE). Receives: Procedure: Transarterial Chemoembolization(TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor size
Measured: the 8th week after TACE operation
Secondary outcomes (2)
the number of CD4+T cell,CD8+T cell in blood
Measured: 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
Measured: the 8th week after TACE operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start27 Jan 2019
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaonan Cui, MD,PhD, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843229
- Sponsor's protocol ID
- PJ-KS-KY-2018-07(x)
- Status last verified
- Feb 2019
- First submitted
- 10 Feb 2019
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Cinobufacini Combined With Transarterial Chemoembolization (TACE) on Primary Liver Cancer
- ClinicalTrials.gov ID
- NCT03843229
- Acronym / sponsor ID
- PJ-KS-KY-2018-07(x)
- Conditions
- Liver Cancer
- Keywords
- Cinobufacini
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 27 Jan 2019 (actual)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 18 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Cinobufacini injection, Procedure: Transarterial Chemoembolization(TACE), Drug: cinobufacini tabletThe 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 | Other | Procedure: Transarterial Chemoembolization(TACE)The control group only receives Transarterial Chemoembolization (TACE). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinobufacini injectionThe 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. | Drug | treatment group |
| 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. | Procedure or surgery | control group, treatment group |
| cinobufacini tabletThe 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. | Drug | treatment group |
Primary outcome
tumor size
Time frame: the 8th week after TACE operation
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhang contact
Xiaonan Cui, MD,PhD principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cinobufacini injection, Transarterial Chemoembolization(TACE) and cinobufacini tablet in people with Liver Cancer, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaonan Cui, MD,PhD (+8618098876725, cxn23@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor size (time frame: the 8th week after TACE operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.