HepatomaPhase 2NCT01236690
Study of Hepatoma Treated by Perfusing Cinobufacin Through Hepatic Artery Combining Embolotherapy
A Phase 2 study testing Cinobufacin injection in people with Hepatoma and Cinobufacin Injection, run by Changhai Hospital at 1 site in China.
Trial summary
Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatoma, Cinobufacin Injection
- What is being tested?
- Cinobufacin injection
- Type of treatment
- Injection or infusion
- How many people
- 284 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Nov 2013
- Phase
- Phase 2
- 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
- The sex does not limit, age:18-70 years old ;
- The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %;
- The patients have failure in surgical intervention or resection operation recidivist;
- Hepatic function Child-pugh A、B;
- All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;
- The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3;
- The patients participate the clinical trial voluntarily and have already signed informed consent.
Who cannot join
- Main portal vein was obstructed completely;
- The occupation of tumour are 70 % or more than 70 % in the whole liver;
- The patient has recepted TACE or other antineoplaston;
- After carcinosectomy the patient has the prophylactic;
- The patient is with renal inadequacy: Cr≥133 umol/L
- Severe cardiovascular disease;
Show all 10Show fewer
- The patient is with other diseases to influence the proposal;
- All over the body generally have metabasis or be with other malignant neoplastic disease;
- In the process of participation of other medicinal trial;
- Gravidity, lactation ,hypersensitiveness constitution or have already known adverse reaction or taboo.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of TCM, Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, 200433
changquan Ling, Doctor, +86 21 81873539, qiaocuixia@126.com
About this study
Official title: The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas.
Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .
Read the detailed description
Inclusion criterion :
- The sex does not limit, age:18-70 years old .
- The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %
- The patients have failure in surgical intervention or resection operation recidivist
- Hepatic function Child-pugh A、B
- All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results
- The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3
- The patients participate the clinical trial voluntarily and have already signed informed consent
Exclusion criterion :
- Main portal vein was obstructed completely.
- The occupation of tumor are 70 % or more than 70 % in the whole liver
- The patient has TACE or other antineoplaston
- After carcinosectomy the patient has the prophylactic
- The patient is with renal inadequacy: Cr≥133 umol/L
- Severe cardiovascular disease
- The patient is with other diseases to influence the proposal
- Conditions
- Hepatoma, Cinobufacin Injection
- Being tested
- Cinobufacin injection
- Keywords
- Transcatheter arterial embolization, Cinobufacin injection, hepatoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinobufacin injectionDrug
Also called Z34020273
Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
Measured: Nov. 2010 to Nov. 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatomaStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 284 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ling chang quan, doctor, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236690
- Sponsor's protocol ID
- CLing
- Status last verified
- Oct 2010
- First submitted
- 8 Nov 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of the Intermediate and Advanced Hepatoma Treated by Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
- ClinicalTrials.gov ID
- NCT01236690
- Acronym / sponsor ID
- CLing
- Conditions
- Hepatoma, Cinobufacin Injection
- Keywords
- Transcatheter arterial embolization, Cinobufacin injection, hepatoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 284 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 9 Nov 2010 (estimated)
- 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.
Cinobufacini has the effects of anticancer, improving the liver function, elevation of immunity and little side effects, and is important and significant for the patients with hepatitis, liver cirrhosis and hepatomas.
Compared with transarterial chemoembolization (TACE) , the clinical effect of cinobufacini is non-inferior/ equivalent.Compared with TACE, cinobufacini is superior in security .
Detailed description
Inclusion criterion :
- The sex does not limit, age:18-70 years old .
- The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %
- The patients have failure in surgical intervention or resection operation recidivist
- Hepatic function Child-pugh A、B
- All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results
- The patient's prediction of live time>6 months, who can tolerant of TACE and has quality of life ECOG score<3
- The patients participate the clinical trial voluntarily and have already signed informed consent
Exclusion criterion :
- Main portal vein was obstructed completely.
- The occupation of tumor are 70 % or more than 70 % in the whole liver
- The patient has TACE or other antineoplaston
- After carcinosectomy the patient has the prophylactic
- The patient is with renal inadequacy: Cr≥133 umol/L
- Severe cardiovascular disease
- The patient is with other diseases to influence the proposal
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The sex does not limit, age:18-70 years old ;
- The patients have inoperable advanced hepatoma without serious disorder in liver and renal, tumor occupation< 70 %;
- The patients have failure in surgical intervention or resection operation recidivist;
- Hepatic function Child-pugh A、B;
- All the cases have the definite final diagnosis of imageology results such as MRI、CT 、B ultrasonic or cytology results ;
Key exclusion criteria (10 listed)
- Main portal vein was obstructed completely;
- The occupation of tumour are 70 % or more than 70 % in the whole liver;
- The patient has recepted TACE or other antineoplaston;
- After carcinosectomy the patient has the prophylactic;
- The patient is with renal inadequacy: Cr≥133 umol/L
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 |
|---|---|---|
| Cinobufacin injectionAlso: Z34020273Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy | Drug | – |
Primary outcome
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
Time frame: Nov. 2010 to Nov. 2013
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
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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.
Ling chang quan, doctor principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cinobufacin injection in people with Hepatoma and Cinobufacin Injection, run by Changhai Hospital 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 7 inclusion and 10 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 28 Jun 2011. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of the patient's respondence for the therapy is carried out every phase, according to RECIST:CR,PR,SD and PD. (time frame: Nov. 2010 to Nov. 2013). 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 28 Jun 2011.