Hepatocellular CarcinomaTACE HCCNCT00518557
Synergistic Treatment for Hepatocellular Carcinoma (HCC) Using TACE With Antiangiogenesis
A study testing Transcatheter Arterial Chemoembolization in people with Hepatocellular Carcinoma, run by Southeast University, China at 1 site in China.
Trial summary
The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Transcatheter Arterial Chemoembolization
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2007to Dec 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cytologically or histologically documented HCC, who are candidates for TACE
- Child-Pugh Child A or B
- Age >= 18
- Measurable disease by RECIST criteria;
- Performance status ECOG 0-2
- Previous local therapy completed > 4 weeks
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- Written informed consent signed
- Normal organ and marrow function defined as:
- Haematopoietic:
- WBC ≥ 3,000/µlplatelet count > 80,000/mm3
- haemoglobin > 9g/dL
- Hepatic: Albumin ≥ 2.8 g/dl.serum total bilirubin ≤ 3 mg/dl; AST or ALT < 5 x ULN
- Renal: creatinine < 1.5 x ULN
Who cannot join
- Metastases
- Prior or concomitant chemotherapy or radiation therapy
- VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
- Severe and/or uncontrolled medical conditions:
- Congestive heart failure, serious cardiac arrhythmia, active coronary artery
- Severe renal impairment
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- Patients who anticipate receiving major surgery during the course of the
- Pregnant or breastfeeding patients
- Evidence of bleeding diathesis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Interventional Radiology, Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
Xiao-Hui Chen, MD, +86 25 83272121, noriko0706@sohu.com
Gang Deng, MD, +86 25 83272118, dmm1996@sina.com
About this study
Official title: Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma
The purpose of this study is to investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Transcatheter Arterial Chemoembolization
- Keywords
- liver cancer, interventional radiology, Chemoembolization, Safety, Effectiveness
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Arterial ChemoembolizationProcedure or surgery
Also called TAE
The interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All patients of this arm are treated by TACE together with Andostatin. Receives: Procedure: Transcatheter Arterial Chemoembolization |
| 2 | Active comparator | All patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin. Receives: Procedure: Transcatheter Arterial Chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability, Mortality
Measured: 6 months
Secondary outcomes (1)
Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2007 (estimated)
- Study startApr 2007
- Study completionDec 2009 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Investigators
- Gao-Jun Teng, MD, Ph.D, Principal investigator, Zhongda Hospital, Southeast University, Nanjing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00518557
- Sponsor's protocol ID
- SIMCERE-123456
- Acronym
- TACE HCC
- Status last verified
- Jan 2009
- First submitted
- 16 Aug 2007
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination Treatment of TACE With Recombinant Human Endostatin Administrated Via Hepatic Artery in Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00518557
- Acronym / sponsor ID
- TACE HCC / SIMCERE-123456
- Conditions
- Hepatocellular Carcinoma
- Keywords
- liver cancer, interventional radiology, Chemoembolization, Safety, Effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Dec 2009 (estimated)
- First posted
- 20 Aug 2007 (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 investigate safety and potential therapeutic benefits for patients with hepatocellular carcinoma by transcatheter chemoembolization with the recombinant endostatin (commercially available in China)which is also administrated via the hepatic artery. The hypothesis of this protocol is that TACE with antiangiogenic treatment may inhibit the proangiogenic effects induced by the hypoxia of TACE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Transcatheter Arterial ChemoembolizationAll patients of this arm are treated by TACE together with Andostatin. |
| 2 | Active comparator | Procedure: Transcatheter Arterial ChemoembolizationAll patients of this arm are treated by TACE alone: only mixture of Epirubicin and Lipiodol is injected into the feeding arteries of the tumor, without injection of Andostatin. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with cytologically or histologically documented HCC, who are candidates for TACE
- Child-Pugh Child A or B
- Age >= 18
- Measurable disease by RECIST criteria;
- Performance status ECOG 0-2
Key exclusion criteria (9 listed)
- Metastases
- Prior or concomitant chemotherapy or radiation therapy
- VEGF/VEGFR- inhibitors or other anti-angiogenesis agents
- Severe and/or uncontrolled medical conditions:
- Congestive heart failure, serious cardiac arrhythmia, active coronary artery
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 |
|---|---|---|
| Transcatheter Arterial ChemoembolizationAlso: TAEThe interventional procedure is performed as following steps: 1)transcatheter hepatic arterial angiography(including any feeding arteries to the tumor) is performed under a DSA unit; 2) super selectively catheterizaton of feeding arteries to the tumor is reached; 3)30 mg of Andostatin (Simcere Co. China) mixtured with 5 ml Lipiodol is injected into the tumor via the feeding arteries; 4) followed by 10 mg of Epifubicin mixtured with 5 ml of Lipiodol; 5) All feeding arteries to the tumor are occluded which is confirmed by re-angiography. | Procedure or surgery | 1, 2 |
Primary outcome
Safety and tolerability, Mortality
Time frame: 6 months
1 secondary outcome
Tumor volumetry, Changes of Tumor markers such as AFP, Curriculum survival
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- 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.
Gao-Jun Teng, MD, Ph.D principal investigator
Zhongda Hospital, Southeast University, Nanjing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcatheter Arterial Chemoembolization in people with Hepatocellular Carcinoma, run by Southeast University, China 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 13 inclusion and 9 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 22 Jan 2009. 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 Xiao-Hui Chen, MD (+86 25 83272121, noriko0706@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability, Mortality (time frame: 6 months). 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 22 Jan 2009.