Unresectable Hepatocellular CarcinomaPhase 4NCT00829465
Clinical Research of Licartin Combined With TACE in the Treatment of Unresectable Hepatocellular Carcinoma
A Phase 4 study testing Licartin and Transcatheter arterial chemoembolization in people with Unresectable Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital.
Trial summary
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Licartin and Transcatheter arterial chemoembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Dec 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
- diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
- confirmed to recurrent after surgery by pathology;
- KPS score of physical state ≥ 60 points;
- liver function is Child-Pugh A or B class
Who cannot join
- General situation is poor and liver function Child-Pugh is C class;
- there is a serious heart, kidney and blood system diseases in patients;
- poor compliance;
- there is allergy history of biological agents or in a state of allergy;
- pregnancy and breast-feeding women
About this study
Official title: Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. However, its overall effect is not yet satisfactory. As a result, concerning the research of drug for liver cancer and improving the overall efficacy of the treatment of liver cancer has a very real and important clinical significance and social value. Licartin (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
Read the detailed description
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. Licartin injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Licartin, Transcatheter arterial chemoembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LicartinDrug
Also called TACE and Licartin
Licartin
Transcatheter arterial chemoembolizationProcedure or surgery
TACE
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | Not described Receives: Procedure: Transcatheter arterial chemoembolization |
| therapy | Experimental | Not described Receives: Drug: Licartin; Procedure: Transcatheter arterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
OS of 1 years; TTP
Measured: 2008.12--2010-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShenFeng, Eastern Hepatobiliary Surgery Hospital
- Investigators
- Yang yefa, doctor, Study director, Second Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829465
- Sponsor's protocol ID
- EHBH-RCT-2008-013
- Status last verified
- Mar 2016
- First submitted
- 22 Dec 2008
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of in the Treatment of Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00829465
- Acronym / sponsor ID
- EHBH-RCT-2008-013
- Conditions
- Unresectable Hepatocellular Carcinoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jan 2009 (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.
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. After diagnosis, the average survival rate of patient is less than 50% in 6 month, less than 24% in 1 year and 5% in 5 year. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. However, its overall effect is not yet satisfactory. As a result, concerning the research of drug for liver cancer and improving the overall efficacy of the treatment of liver cancer has a very real and important clinical significance and social value. Licartin (Iodine-131-Labeled Metuximab) injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
Detailed description
Liver cancer is a highly invasive malignancy and the rate of surgical resection is no more than 28%. The TACE treatment, under the theoretical basis of blood supply of Liver cancer, is obviously better than the other non-surgical therapy, in terms of tumor regression, AFP decrease, survival time and the evaluation of the quality of life. Licartin injection is a antibody drug with new target and the only drug that China own the intellectual property rights. It has specific high affinity with HAb18G/CD147, the liver cell membrane antigen. Labeled 131I is taken to the liver tissue, owning high-dose concentration and releasing β particles to liver cancer cells to and kill cancer cells.
The Second Military Medical University, Eastern Hepatobiliary Surgery Hospital, planed to use the treatment of Licartin combined with TACE for the patients of unresectable hepatocellular carcinoma and evaluate the difference of tumor size, AFP change, TTP, the overall survival rate between different treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Procedure: Transcatheter arterial chemoembolization |
| therapy | Experimental | Drug: Licartin, Procedure: Transcatheter arterial chemoembolization |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- the participation is entirely voluntary, good at compliance, sign the informed consent form in person;
- diagnosed to be hepatocellular carcinoma by clinical method, imaging method and tumor markers; and the surgeons determine who can not undergo surgery;
- confirmed to recurrent after surgery by pathology;
- KPS score of physical state ≥ 60 points;
- liver function is Child-Pugh A or B class
Key exclusion criteria (5 listed)
- General situation is poor and liver function Child-Pugh is C class;
- there is a serious heart, kidney and blood system diseases in patients;
- poor compliance;
- there is allergy history of biological agents or in a state of allergy;
- pregnancy and breast-feeding women
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 |
|---|---|---|
| LicartinAlso: TACE and LicartinLicartin | Drug | therapy |
| Transcatheter arterial chemoembolizationTACE | Procedure or surgery | control, therapy |
Primary outcome
OS of 1 years; TTP
Time frame: 2008.12--2010-12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
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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.
Yang yefa, doctor study director
Second Military Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Licartin and Transcatheter arterial chemoembolization in people with Unresectable Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital.
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 5 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: finished, as of the sponsor's last update on 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OS of 1 years; TTP (time frame: 2008.12--2010-12). 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 1 Apr 2016.