Hepatocellular CarcinomaNCT00644020
Phase ⅡStudy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
An observational study of Hepatocellular Carcinoma, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- mitomycin, Fluorouracil
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2007to Aug 2008
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC complicating branch cork after resection
Who may be able to join
- Written informed consent
- Age between 18 and 75 years
- Hepatocellular Carcinoma accompanied with branch vein thrombosis
- Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
- CTA or MRI no Carcinoma and bolt after operation
Who cannot join
- hypersensitivity to the composition similarity of investigational drug
- Concomitance other system primary tumor
- surface area 1.47m2～1.92m2
- HBV (-) and HCV(-)
- Patients who have received resectional surgery for HCC
- HCC complicating main portal vein cork
Show all 15Show fewer
- HCC complicating hepatic vein cork
- Patients who have received systematicness therapy for HCC
- Patients who have received immunoregulant 4 weeks before randomization
- Concurrent participation in another clinical trial involving experimental treatment is excluded 4 weeks before randomization
- uncontrolled infection, hemorrhage, guts leakage postoperative complications
- postoperative liver function Child-pugh C
- no evidence of extra-hepatic metastases postoperative
- no utility sample for gene chip research
- no physical examination, laboratory and imageology examination that baseline request
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
A Research Institute of Tumor
Guangzhou, Guangdong, 510060
Weihua Jia, Professor, 020-87343370
Yaqi Zhang, Professor
About this study
Official title: A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.
Read the detailed description
- Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.
- Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.
- Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.
- A CT scan or MRI scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- mitomycin, Fluorouracil
- Keywords
- Hepatocellular carcinoma, recurrence
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mitomycin, FluorouracilDrug
Also called mitomycin: serial numbers:071006, Fluorouracil: serial numbers:0710071
All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | the Tyroserleutide for injection at the dosage of 3mg/d Receives: Drug: mitomycin, Fluorouracil | |
| Group 2 | the Tyroserleutide for injection at the dosage of 6mg/d Receives: Drug: mitomycin, Fluorouracil | |
| Group 3 | the Tyroserleutide for injection at the dosage of 12mg/d Receives: Drug: mitomycin, Fluorouracil | |
| Group 4 | the placebo group Receives: Drug: mitomycin, Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS(disease free survival)
Measured: six month
Secondary outcomes (1)
1.OS （Overall Survival） 2.QOL (quality of life)
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Chen X P, Professor, Principal investigator, Tongji Medical College of Huazhong University of ScienceTechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644020
- Sponsor's protocol ID
- TYS-CN-1.1PUMPⅡPartA
- Other IDs
- TYS-CN-1.1PUMPⅡPartA
- Status last verified
- Dec 2007
- First submitted
- 23 Mar 2008
- Last updated
- 26 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controled, Multicenter Phase ⅡStudy to Evaluate the Safety and Efficacy of Tyroserleutide for Injection in Hepatocellular Carcinoma(HCC) Patients
- ClinicalTrials.gov ID
- NCT00644020
- Acronym / sponsor ID
- TYS-CN-1.1PUMPⅡPartA
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 26 Mar 2008 (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.
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 4 groups, including 3mg, 6mg, 12mg per day and placebo group. Each group includes 25 subjects, who have hepatic-cellular carcinoma accompanied with branch vein thrombosis. They receive investigational drug 40 days after resection surgery. Each cycle lasts 4 to 6 days with an interval of 29 days in all 6 cycles.
Detailed description
- Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the TYROSERLEUTIDE treatment group or the placebo group. No matter which group the subject is assigned, he/she would receive chemotherapy treatment through the portal vein pump which was transplanted during the carcinoma section surgery 40 days before the randomization.
- Participants will be given either TYROSERLEUTIDE or placebo through intravenous injection with an interval of 29 days, during which the participant will not take any investigational drug or any other anti-tumor treatment as well. On the day just next to the completion of each cycle of research treatment which usually lasts for 3-5 days, the participant will receive medical inspection so as to observe and ensure drug safety.
- Participants will continue to receive investigational drug for 6 cycles until being detected with recurrence or metastasis of tumor or experiencing any serious side effects.
- A CT scan or MRI scan will be performed for each participant to exclude the recurrence or metastasis of tumor and assess the effects of treatment once before the initiation of each new cycle.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: mitomycin, Fluorouracilthe Tyroserleutide for injection at the dosage of 3mg/d |
| Group 2 | – | Drug: mitomycin, Fluorouracilthe Tyroserleutide for injection at the dosage of 6mg/d |
| Group 3 | – | Drug: mitomycin, Fluorouracilthe Tyroserleutide for injection at the dosage of 12mg/d |
| Group 4 | – | Drug: mitomycin, Fluorouracilthe placebo group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC complicating branch cork after resection
Key inclusion criteria (5 listed)
- Written informed consent
- Age between 18 and 75 years
- Hepatocellular Carcinoma accompanied with branch vein thrombosis
- Carcinoma and bolt resection Integrity, cutting edge no tumor cells by microscopic lens in operation
- CTA or MRI no Carcinoma and bolt after operation
Key exclusion criteria (15 listed)
- hypersensitivity to the composition similarity of investigational drug
- Concomitance other system primary tumor
- surface area 1.47m2～1.92m2
- HBV (-) and HCV(-)
- Patients who have received resectional surgery for HCC
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 |
|---|---|---|
| mitomycin, FluorouracilAlso: mitomycin: serial numbers:071006, Fluorouracil: serial numbers:0710071All participants will receive 10mg mitomycin and 1g Fluorouracil through the chemoradiative pump which was transplanted during the operation, and this procedure would be executed a day before each research treatment period. | Drug | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
DFS(disease free survival)
Time frame: six month
1 secondary outcome
1.OS （Overall Survival） 2.QOL (quality of life)
Time frame: six month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
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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.
Chen X P, Professor principal investigator
Tongji Medical College of Huazhong University of ScienceTechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. 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 5 inclusion and 15 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 26 Mar 2008. 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.
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 Chen X P, professor (027-83662599, chenxp_53@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DFS(disease free survival) (time frame: six month). 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 26 Mar 2008.