Carcinoma, HepatocellularTACE-KMGNCT01393197
Transcatheter Arterial Chemoembolization With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas (TACE-KMG)
A study testing Therapeutic Chemoembolization in people with Carcinoma, Hepatocellular, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol? Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Therapeutic Chemoembolization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,480 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
- liver function:Child-Pugh A、B
- PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
- Lifespan≥6 months
- First time to receive treatment
- Can accept the follow up
- informed consent was gotten
- the number of lesion ≤ 5
Who cannot join
- pregnant or lactation woman
- emotional disturbance
- serious heart ,lung disfunction or serious diabetes mellitus
- serious reactiveness infections;（exp:type B or C hepatitis）
- liver function :Child-Pugh Score C
- thrombocyte<6×109/L
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- diffuse HCC
- widespread metastasis
- serious atherosclerosis
- acquired immunodeficiency syndrome;AIDS
- thrombosis or thrombosis event in 6 months
- renal inadequacy who need hemodialysis or peritoneal dialysis
- with other tumors except basal cell carcinoma and carcinoma in situ of cervix
- serious alimentary tract hemorrhage in 4 weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Zhi Guo, MD, 13920076145, cjr.guozhi@vip.163.com
Haipeng Yu, MD, 13352070835, jieruke@yahoo.com.cn
About this study
Official title: Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
The purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?
Read the detailed description
The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Therapeutic Chemoembolization
- Keywords
- HCC, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic ChemoembolizationOther
Also called Transcatheter Arterial Chemoembolization，TACE
Transcatheter Arterial Chemoembolization
| Study group | Role | What they receive |
|---|---|---|
| TACE -oil | Active comparator | embolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge Receives: Other: Therapeutic Chemoembolization |
| TACE-KMG ( routine dose Chemo) | Experimental | embolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2） Receives: Other: Therapeutic Chemoembolization |
| TACE-KMG( low dose Chemo ) | Experimental | embolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2） Receives: Other: Therapeutic Chemoembolization |
| TACE-KMG(without chemo) | Experimental | embolization agent:KMG microsphere( 150-450µm,0.2-2g) Receives: Other: Therapeutic Chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
Time to progression
Measured: 3 years
Secondary outcomes (2)
total survival
total survival
Measured: 3 years
remission rate
remission rate
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,480 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhi Guo, MD, Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393197
- Sponsor's protocol ID
- TMU-CIH-IR-003
- Acronym
- TACE-KMG
- Status last verified
- Nov 2010
- First submitted
- 11 Jul 2011
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Transcatheter Arterial Chemoembolization (TACE)With KMG Microsphere Treating Advance-stage Hepatocellular Carinomas
- ClinicalTrials.gov ID
- NCT01393197
- Acronym / sponsor ID
- TACE-KMG / TMU-CIH-IR-003
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- HCC, TACE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,480 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 Jul 2011 (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 purpose of this study is to evaluate the effects of Transcatheter Arterial Chemoembolization (TACE) with KMG microsphere in treating HCC. And to determine which one is better,KMG microsphere or lipiodol?
Detailed description
The most important part of effect in TACE is embolization .But there is no clinical trials on which one is better,KMG microsphere or lipiodol? what effect did chemo play in the TACE treating HCC? Which one is better,routine dose or low dose? Experts in USA and Japan had their own researches and standpoints.We think it is important to push a clinical trail to answer these problem.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TACE -oil | Active comparator | Other: Therapeutic Chemoembolizationembolization agent:Iodinated Oil or /and gelatin sponge Iodinated Oil （5-30ml）with Epirubicin （30-40mg/m2） or and gelatin sponge |
| TACE-KMG ( routine dose Chemo) | Experimental | Other: Therapeutic Chemoembolizationembolization agent:KMG microsphere( 150-450µm,0.2-2g) with routine dose Epirubicin （30-40mg/m2） |
| TACE-KMG( low dose Chemo ) | Experimental | Other: Therapeutic Chemoembolizationembolization agent:KMG microsphere( 150-450µm,0.2-2g) with low dose Epirubicin （5-10mg/m2） |
| TACE-KMG(without chemo) | Experimental | Other: Therapeutic Chemoembolizationembolization agent:KMG microsphere( 150-450µm,0.2-2g) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Hepatocellular Carinomas with diagnosis of pathology or cytology or consistent with China 2001 guideline of Clinical Diagnosis Hepatocellular Carinomas clinical stage（The Barcelona Liver Clinic staging system,BCLC B and C)，or can not receive surgical intervention
- liver function:Child-Pugh A、B
- PST 0-1（Eastern Cooperative Oncology Group Performance Score ,ECOG）
- Lifespan≥6 months
- First time to receive treatment
Key exclusion criteria (14 listed)
- pregnant or lactation woman
- emotional disturbance
- serious heart ,lung disfunction or serious diabetes mellitus
- serious reactiveness infections;（exp:type B or C hepatitis）
- liver function :Child-Pugh Score C
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 |
|---|---|---|
| Therapeutic ChemoembolizationAlso: Transcatheter Arterial Chemoembolization，TACETranscatheter Arterial Chemoembolization | Other | TACE -oil, TACE-KMG ( routine dose Chemo), TACE-KMG( low dose Chemo ), TACE-KMG(without chemo) |
Primary outcome
Time to progression
Time frame: 3 years
Time to progression
2 secondary outcomes
total survival
Time frame: 3 years
remission rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
- Related InfoLink provided by the sponsor.
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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.
Zhi Guo, MD study chair
Tianjin Medical University Cancer Institute and Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Chemoembolization in people with Carcinoma, Hepatocellular, run by Tianjin Medical University Cancer Institute and 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 8 inclusion and 14 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 Dec 2015. 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 Zhi Guo, MD (13920076145, cjr.guozhi@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: 3 years). 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 Dec 2015.