Carcinoma, HepatocellularPhase 3NCT02338297
Therapeutic Effect of Ethanol-gelfoam Mixture for the Treatment of Arterioportal Shunts (APS) in Patients With HCC
A Phase 3 study testing TACE, EGM and PVA in people with Carcinoma, Hepatocellular, run by Nanjing Medical University at 2 sites in China.
Trial summary
Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- TACE, EGM and PVA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesChina
- Study dates
- Feb 2016to Dec 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- Child-Pugh A or B cirrhosis
- ECOG performance status Grade 2 or below
- No serious concurrent medical illness
- No prior treatment (including surgery) for HCC
- Histologically or cytologically proven HCC (an alphafetoprotein level > 500 ug/ml in the presence of radiological findings suggestive of HCC in a patient with chronic HBV or HCV infection can be considered eligible at investigator's discretion)
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- Unresectable and locally advanced disease without extra-hepatic disease
- Massive expansive or nodular tumor morphology with measurable lesion on CT
- Size of largest tumor <= 15cm in largest dimension
- Number of main tumor <= 5, excluding associated small satellite lesions
- Arterioportal shunts (APS) is found in the angiography of HCC blood supply
Who cannot join
- History of prior malignancy except skin cancer
- History of significant concurrent medical illness such as ischemic heart disease or heart failure
- History of acute tumor rupture
- Serum creatinine level > 180 umol/L
- Presence of biliary obstruction not amenable to percutaneous drainage
- Child-Pugh C cirrhosis
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- History of hepatic encephalopathy, or
- Intractable ascites not controllable by medical therapy, or
- History of variceal bleeding within last 3 months, or
- Serum total bilirubin level > 50 umol/L, or
- Serum albumin level < 28g/L, or
- INR > 1.3
- Presence of extrahepatic metastasis
- Predominantly infiltrative lesion
- Diffuse tumor morphology with extensive lesions involving both lobes.
- Hepatic artery thrombosis, or
- Partial or complete thrombosis of the main portal vein, or
- Tumor invasion of portal branch of contralateral lobe, or
- Hepatic vein tumor thrombus
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210009
Shi, shihb@njmu.edu.cn
Haibin Shi, MD, PhD.
- Recruiting
Zhong da hospital, Southeast university
Nanjing, Jiangsu, 210009
Gaojun Teng, MD., PhD., 02583272121, gjteng@vip.sina.com
About this study
Official title: A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)
Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.
Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).
The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- TACE, EGM, PVA
- Keywords
- Hepatocellular Carcinoma, Arterioportal shunts, Transarterial Chemoembolization, Ethanol, Gelfoam, Polyvinyl Alcohol Foam Embolization Particles (PVA)
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACEProcedure or surgery
Transarterial chemoembolisation (TACE)
EGMDrug
Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
PVADrug
Occlude arterioportal shunts(APS) with PVA
| Study group | Role | What they receive |
|---|---|---|
| TACE+EGM | Experimental | Occlude APS with EGM and perform TACE sequentially Receives: Procedure: TACE; Drug: EGM |
| TACE+PVA | Active comparator | Occlude APS with PVA and perform TACE sequentially Receives: Procedure: TACE; Drug: PVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
Measured: 3 years
APS improvement
Changes of Arterioportal Shunts Treated with PVA or EGM
Measured: 2 month
Secondary outcomes (3)
Time To Progression
Time from randomization to radiological progression. Definition of progression is based on the mRECIST criteria. Deaths during follow-up without evidence of radiological progression are censored.
Measured: every 8 weeks, upto 3 years from date of randomization
progression free survival
Time from randomization to either radiological progression or death. Patients alive and free of progression at the end of follow-up are censored.
Measured: every 8 weeks, upto 3 years from date of randomization
Response Rate
Definition of response is based on the mRECIST criteria.
Measured: every 8 weeks, upto 3 years from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2015 (estimated)
- Study startFeb 2016
- Primary completionFeb 2017 (estimated)
- Study completionDec 2017 (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 Nanjing Medical UniversityThe 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
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hai-Bin Shi, Nanjing Medical University
- Investigators
- Haibin Shi, MD, PhD., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02338297
- Sponsor's protocol ID
- HCC001
- Status last verified
- Nov 2015
- First submitted
- 18 Dec 2014
- 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
- A Randomized Controlled Trial of Ethanol-gelfoam Mixture(EGM) Versus Gelfoam for the Treatment of Arterioportal Shunts (APS) in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolization (TACE)
- ClinicalTrials.gov ID
- NCT02338297
- Acronym / sponsor ID
- HCC001
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Hepatocellular Carcinoma, Arterioportal shunts, Transarterial Chemoembolization, Ethanol, Gelfoam, Polyvinyl Alcohol Foam Embolization Particles (PVA)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 Jan 2015 (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.
Transcatheter arterial chemoembolization (TACE) is a key palliative treatment for patients with inoperable hepatocellular carcinoma (HCC). Arterioportal shunts (APS) can aggravate portal hypertension and the shunts let lipiodol flow to normal liver tissue and result in poor Lipiodol deposition in the tumor, causing liver ischemia.
Occlusion of APS is a vital and initial step for the following embolization of tumor. Ethanol-gelfoam mixture(EGM) and gelfoam only both can occlude APS in patients with hepatocellular carcinoma (HCC).
The aim of this study was to evaluate the efficacy and safety of EGM in treatment of APS in the procedure of TACE, and to analyze the prognostic factors for survival in this kind of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TACE+EGM | Experimental | Procedure: TACE, Drug: EGMOcclude APS with EGM and perform TACE sequentially |
| TACE+PVA | Active comparator | Procedure: TACE, Drug: PVAOcclude APS with PVA and perform TACE sequentially |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18
- Child-Pugh A or B cirrhosis
- ECOG performance status Grade 2 or below
- No serious concurrent medical illness
- No prior treatment (including surgery) for HCC
Key exclusion criteria (19 listed)
- History of prior malignancy except skin cancer
- History of significant concurrent medical illness such as ischemic heart disease or heart failure
- History of acute tumor rupture
- Serum creatinine level > 180 umol/L
- Presence of biliary obstruction not amenable to percutaneous drainage
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 |
|---|---|---|
| TACETransarterial chemoembolisation (TACE) | Procedure or surgery | TACE+EGM, TACE+PVA |
| EGMOcclude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM) | Drug | TACE+EGM |
| PVAOcclude arterioportal shunts(APS) with PVA | Drug | TACE+PVA |
Primary outcome
overall survival
Time frame: 3 years
Defined as time (in days) from time of TACE non-eligibility to death due to any cause, and will be evaluated every 8 weeks in the protocol treatment, and every one year in the follow-up period, respectively. Patients lost to follow-up or alive at the end of the study will be censored at the last date known to be alive.
APS improvement
Time frame: 2 month
Changes of Arterioportal Shunts Treated with PVA or EGM
3 secondary outcomes
Time To Progression
Time frame: every 8 weeks, upto 3 years from date of randomization
progression free survival
Time frame: every 8 weeks, upto 3 years from date of randomization
Response Rate
Time frame: every 8 weeks, upto 3 years from date of randomization
Results and safety
Results are not available in the source record.
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.
Haibin Shi, MD, PhD. principal investigator
The First Affiliated Hospital with Nanjing Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TACE, EGM and PVA in people with Carcinoma, Hepatocellular, run by Nanjing Medical University at 2 sites 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 11 inclusion and 19 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 1 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haibin Shi, MD, PhD. (086-025 681 369 18, shihb@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 3 years). The study lists 2 primary outcomes in all. 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.