Liver CancerPhase 3NCT02038296
Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
A Phase 3 study testing transarterial chemoembolization in people with Liver Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cancer
- What is being tested?
- transarterial chemoembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Mar 2013
- Phase
- Phase 3
- 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
- Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
- HCC with no previous treatment;
- age between 18 and 75 years;
- Life expectancy of at least 8 weeks;
- main tumor size greater than 5 cm;
- adequate hematologic function (platelet count: >60 × 109 platelets/L; hemoglobin: >90g/L; and prothrombin time: <3 seconds above control);
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- adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
- Child-Pugh classification A or B grade;
- Barcelona Clinic Liver Cancer (BCLC) stage B or C;
- Eastern Co-operative Group performance status of zero or one.
Who cannot join
- a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
- diffuse-type HCC;
- evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
- severe underlying cardiac or renal diseases;
- color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Interventional Radiology; Cancer Center; Guangdong General Hospital
Guangzhou, Guangdong, 510080
About this study
To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.
- Conditions
- Liver Cancer
- Being tested
- transarterial chemoembolization
- Keywords
- Hepatocellular carcinoma, Transarterial chemoembolization, Gemcitabine
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transarterial chemoembolizationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Group 1 received single-drug (doxorubicin)transarterial chemoembolization. Receives: Procedure: transarterial chemoembolization |
| Group 2 | Experimental | Group 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization Receives: Procedure: transarterial chemoembolization |
| Group 3 | Experimental | Group 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization. Receives: Procedure: transarterial chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2008
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038296
- Sponsor's protocol ID
- TAE001
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2014
- Last updated
- 17 Jan 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02038296
- Acronym / sponsor ID
- TAE001
- Conditions
- Liver Cancer
- Keywords
- Hepatocellular carcinoma, Transarterial chemoembolization, Gemcitabine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Jan 2014 (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.
To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Procedure: transarterial chemoembolizationGroup 1 received single-drug (doxorubicin)transarterial chemoembolization. |
| Group 2 | Experimental | Procedure: transarterial chemoembolizationGroup 2 received double-drug (doxorubicin and mitomycin C)transarterial chemoembolization |
| Group 3 | Experimental | Procedure: transarterial chemoembolizationGroup 3 were treated with triple-drug (doxorubicin, mitomycin C and gemcitabine)transarterial chemoembolization. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
- HCC with no previous treatment;
- age between 18 and 75 years;
- Life expectancy of at least 8 weeks;
- main tumor size greater than 5 cm;
Key exclusion criteria (5 listed)
- a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
- diffuse-type HCC;
- evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
- severe underlying cardiac or renal diseases;
- color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.
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 |
|---|---|---|
| transarterial chemoembolization | Procedure or surgery | Group 1, Group 2, Group 3 |
Primary outcome
overall survival
Time frame: 1-2 year
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 17 Jan 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transarterial chemoembolization in people with Liver Cancer, run by Guangdong Provincial People's 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 10 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 17 Jan 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
overall survival (time frame: 1-2 year). 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 17 Jan 2014.