Hepatocellular CarcinomaPhase 3NCT02149771
Combination Treatment for Advanced Liver Cancer
A Phase 3 study testing chemoembolization, endovascular stents implantation and iodine-125 seed strand implantation in people with Hepatocellular Carcinoma and Hepatic Portal Vein Tumor Invasion, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatic Portal Vein Tumor Invasion
- What is being tested?
- chemoembolization, endovascular stents implantation and iodine-125 seed strand implantation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Sep 2016
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
- (2) Child-Pugh classification grade A or B；
- （3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
Who cannot join
- advanced liver disease (bilirubin levels >3 mg/dL, ASTor ALT >5 × upper limit of normal)；
- Tumor invade the Inferior Vena Cava, extrahepatic spread;
- contraindications for doxorubicin or oxaliplatin chemotherapy;
- any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
- renal failure,cardiac ejection fraction <50 %) or end-stage disease；
- patients who were not capable of cooperation during the procedure.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone
The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.
- Being tested
- chemoembolization, endovascular stents implantation, iodine-125 seed strand implantation
- Keywords
- hepatocellular carcinoma, portal vein tumor thrombosis, stents, chemoembolization
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoembolizationProcedure or surgery
Conventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.
endovascular stents implantationDevice
Bare stents implant within portal vein.
iodine-125 seed strand implantationProcedure or surgery
Iodine-125 seed strand implant within portal vein.
| Study group | Role | What they receive |
|---|---|---|
| TACE&Stents | Experimental | chemoembolization combined with endovascular stents and iodine-125 seed strand implantation Receives: Procedure: chemoembolization; Device: endovascular stents implantation; Procedure: iodine-125 seed strand implantation |
| TACE | Active comparator | Transartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI. Receives: Procedure: chemoembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median survival time
Measured: 2 years
Secondary outcomes (1)
Time to Disease Progression
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 posted29 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionSep 2016
Why it stopped: Insufficient funding
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.
- More trials run by Shanghai Zhongshan 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Responsible party
- Principal investigator, Zhiping Yan, Shanghai Zhongshan Hospital
- Investigators
- Zhinping Yan, MD, Principal investigator, Department of Interventional Radiology, Zhongshan Hospital, Fudan UniversityJianjun Luo, MD, Study director, Department of Interventional Radiology, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02149771
- Sponsor's protocol ID
- ZS-IR 2013
- Status last verified
- Apr 2018
- First submitted
- 25 May 2014
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarterial Chemoembolisation (TACE) Combined With Endovascular Implantation of Bare Stent and Iodine-125 Seed Strand for the Treatment of Hepatocellular Carcinoma With Portal Vein Tumour Thrombosis Versus TACE Alone
- ClinicalTrials.gov ID
- NCT02149771
- Acronym / sponsor ID
- ZS-IR 2013
- Keywords
- hepatocellular carcinoma, portal vein tumor thrombosis, stents, chemoembolization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Municipal Science and Technology Commission
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 May 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.
The purpose of this study is to determine whether TACE combined endovascular stent implantation confers a survival benefit over TACE alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE&Stents | Experimental | Procedure: chemoembolization, Device: endovascular stents implantation, Procedure: iodine-125 seed strand implantationchemoembolization combined with endovascular stents and iodine-125 seed strand implantation |
| TACE | Active comparator | Procedure: chemoembolizationTransartery chemoembolisation（TACE） by administering Doxorubicin and Oxaliplatin mixed with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (1) Hepatocellular carcinoma(HCC) diagnosis confirmed by needle biopsy or by two coincidental imaging techniques associated with increased α-fetoprotein according to the American Association for the Study of Liver Diseases (AASLD) guidelines and contrast-enhancing tumour thrombus within the main portal vein and one of the first-order branch on CT or MRI;
- (2) Child-Pugh classification grade A or B；
- （3）Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
Key exclusion criteria (6 listed)
- advanced liver disease (bilirubin levels >3 mg/dL, ASTor ALT >5 × upper limit of normal)；
- Tumor invade the Inferior Vena Cava, extrahepatic spread;
- contraindications for doxorubicin or oxaliplatin chemotherapy;
- any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
- renal failure,cardiac ejection fraction <50 %) or end-stage disease；
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 |
|---|---|---|
| chemoembolizationConventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI. | Procedure or surgery | TACE, TACE&Stents |
| endovascular stents implantationBare stents implant within portal vein. | Device | TACE&Stents |
| iodine-125 seed strand implantationIodine-125 seed strand implant within portal vein. | Procedure or surgery | TACE&Stents |
Primary outcome
Median survival time
Time frame: 2 years
1 secondary outcome
Time to Disease Progression
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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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.
Zhinping Yan, MD principal investigator
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Jianjun Luo, MD study director
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
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 chemoembolization, endovascular stents implantation and iodine-125 seed strand implantation in people with Hepatocellular Carcinoma and Hepatic Portal Vein Tumor Invasion, run by Shanghai Zhongshan 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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Apr 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Median survival time (time frame: 2 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 19 Apr 2018.