Hepatocellular CarcinomaPhase 3NCT02971345
Endovascular Brachytherapy Combined With Stent Placement and TACE for HCC With Main Portal Vein Tumor Thrombus
A Phase 3 study testing Stent and Iodine-125 seed strand implantation, Stent and Iodine-125 seed in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma, Portal Vein Tumor Thrombus
- What is being tested?
- Stent and Iodine-125 seed strand implantation, Stent and Iodine-125 seed
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Nov 2020
- 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 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;
- (2) According to the Barcelona Clinic Liver Cancer staging classification, HCC was unsuitable for resection, liver transplantation or percutaneous radiofrequency ablation;
- (3) Tumor thrombus, a low-attenuation intraluminal filling defect extending from intrahepatic portal vein branches adjacent to primary tumor into main portal vein, was confirmed by contrast-enhanced abdominal computer tomography (CT) or magnetic resonance imaging (MRI)
- (4) At least the first-order branch of the intrahepatic portal vein was patent in one lobe;
- (5) Child-Pugh classification grade A or B;
- (6) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less;
Who cannot join
- (1) Patients had a history of any therapy for HCC or portal vein tumor thrombus;
- (2) Advanced liver disease (bilirubin levels >3 mg/dL, Aspartate transaminase or Alanine aminotransferase >5 × upper limit of normal)；
- (3) Tumor invade the Inferior Vena Cava, extrahepatic spread;
- (4) Any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
- (5) Renal failure,cardiac ejection fraction (<50 %) or end-stage disease;
- (6) Patients who were not capable of cooperation during the procedure.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Interventional Radiology, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Jianjun Luo, MD, zhangzihan0217@126.com
Zhinping Yan, MD
About this study
Official title: Endovascular Brachytherapy Combined With Stent Placement and Transcatheter Arterial Chemoembolization (TACE) for Treatment of HCC With Main Portal Vein Tumor Thrombus Versus TACE Alone: a Prospective Randomized Controlled Multicentre Trial
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.
Read the detailed description
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Zhi-ping Yan.Investigators in twenty-seven hospitals in China participate in.Patients with unresectable HCC with main portal vein tumor thrombus are enrolled. The investigators propose to recruitment 253 patients who are randomly assigned into the combined group (treated with endovascular brachytherapy combined with stent placement and TACE) and the control group (treated with TACE alone).There are 127 patients in combined group and 126 patients in control group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
- Being tested
- Stent and Iodine-125 seed strand implantation, Stent, Iodine-125 seed, Epirubicin, Ultra-fluid lipiodol
- Keywords
- Hepatocellular carcinoma, main portal vein tumor thrombus, endovascular brachytherapy, stent, 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.
Stent and Iodine-125 seed strand implantationProcedure or surgery
The patent second-order branch of the intrahepatic portal vein was punctured with a 22-gauge Chiba needle under ultrasound guidance.Stent and Iodine-125 seed strand are implanted by two 0.035-inch,150-cm-long wire.
StentDevice
Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.
Iodine-125 seedDevice
The number of Iodine-125 seeds planned to be implanted was calculated by the following formula: N = length of obstructed main portal vein (mm)/4.5 + 4. These seeds were arranged linearly and sealed into a 4-F catheter continuously to construct a Iodine-125 seed strand.
EpirubicinDrug
Epirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 30-60 mg per patient,depending on the situation of the patient.
Ultra-fluid lipiodolDrug
Also called lipiodol
Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
Gelatin sponge articlesOther
Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Brachytherapy&Stent&TACE | Experimental | Transarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation.
Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE. Receives: Procedure: Stent and Iodine-125 seed strand implantation; Device: Stent; Device: Iodine-125 seed; Drug: Epirubicin; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles |
| TACE alone | Active comparator | Only TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. Receives: Drug: Epirubicin; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: From the date of randomization until the date of death from any cause, assessed up to 24 months
Secondary outcomes (1)
Time To Progression
Time to progression follow-up is done at three months interval after lesions defined as stable with treatment of TACE or combined therapy six months after enrollment until lesions are defined as disease progression.
Measured: From the date of first procedure of TACE or combined therapy until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 253 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Lishui Country People's Hospital, Zhejiang University, Changhai Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Yibin, The First Affiliated Hospital of Shanxi Medical University, LanZhou University, The First Affiliated Hospital of Zhengzhou University, First Hospital of China Medical University, Fujian Medical University Union Hospital, Fujian Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, ZhuHai Hospital, Zhongshan Hospital Xiamen University, Yancheng Third People's Hospital, Changzhou Wujin People's Hospital, Tengzhou Central People's Hospital, Harbin Medical University, Hunan Cancer Hospital, First Affiliated Hospital of Zhejiang University
- Responsible party
- Sponsor
- Investigators
- Zhiping 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
- NCT02971345
- Sponsor's protocol ID
- ZS-IR-2016
- Status last verified
- Jun 2020
- First submitted
- 20 Nov 2016
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Luo J, Yan Z, Liu Q, Qu X, Wang J. Endovascular placement of iodine-125 seed strand and stent combined with chemoembolization for treatment of hepatocellular carcinoma with tumor thrombus in main portal vein. J Vasc Interv Radiol. 2011 Apr;22(4):479-89. doi: 10.1016/j.jvir.2010.11.029.
PubMed 21463757Luo JJ, Zhang ZH, Liu QX, Zhang W, Wang JH, Yan ZP. Endovascular brachytherapy combined with stent placement and TACE for treatment of HCC with main portal vein tumor thrombus. Hepatol Int. 2016 Jan;10(1):185-95. doi: 10.1007/s12072-015-9663-8. Epub 2015 Sep 4.
PubMed 26341514Yang M, Fang Z, Yan Z, Luo J, Liu L, Zhang W, Wu L, Ma J, Yang Q, Liu Q. Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial. J Cancer Res Clin Oncol. 2014 Feb;140(2):211-9. doi: 10.1007/s00432-013-1568-0. Epub 2013 Dec 28.
PubMed 24374800
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Brachytherapy Combined With Stent Placement and Transcatheter Arterial Chemoembolization (TACE) for Treatment of HCC With Main Portal Vein Tumor Thrombus Versus TACE Alone: a Prospective Randomized Controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT02971345
- Acronym / sponsor ID
- ZS-IR-2016
- Keywords
- Hepatocellular carcinoma, main portal vein tumor thrombus, endovascular brachytherapy, stent, chemoembolization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 253 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Ruijin Hospital, RenJi Hospital, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, The First Affiliated Hospital of Soochow University, The First Affiliated Hospital with Nanjing Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Lishui Country People's Hospital, Zhejiang University, Changhai Hospital, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, The First Affiliated Hospital of Anhui Medical University, The Second People's Hospital of Yibin, The First Affiliated Hospital of Shanxi Medical University, LanZhou University, The First Affiliated Hospital of Zhengzhou University, First Hospital of China Medical University, Fujian Medical University Union Hospital, Fujian Provincial Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, ZhuHai Hospital, Zhongshan Hospital Xiamen University, Yancheng Third People's Hospital, Changzhou Wujin People's Hospital, Tengzhou Central People's Hospital, Harbin Medical University, Hunan Cancer Hospital, First Affiliated Hospital of Zhejiang University
- Study start
- Jan 2017
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 22 Nov 2016 (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.
It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and endovascular brachytherapy combined with stent placement and TACE for HCC with main portal vein tumor thrombus.
Detailed description
It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Zhi-ping Yan.Investigators in twenty-seven hospitals in China participate in.Patients with unresectable HCC with main portal vein tumor thrombus are enrolled. The investigators propose to recruitment 253 patients who are randomly assigned into the combined group (treated with endovascular brachytherapy combined with stent placement and TACE) and the control group (treated with TACE alone).There are 127 patients in combined group and 126 patients in control group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Brachytherapy&Stent&TACE | Experimental | Procedure: Stent and Iodine-125 seed strand implantation, Device: Stent, Device: Iodine-125 seed, Drug: Epirubicin, Drug: Ultra-fluid lipiodol, Other: Gelatin sponge articlesTransarterial chemoembolization (TACE) is performed immediately following Iodine-125 seed strand and stent implantation. Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE. |
| TACE alone | Active comparator | Drug: Epirubicin, Drug: Ultra-fluid lipiodol, Other: Gelatin sponge articlesOnly TACE is performed. Epirubicin, ultra-fluid lipiodol and gelatin sponge articles are used in TACE. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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;
- (2) According to the Barcelona Clinic Liver Cancer staging classification, HCC was unsuitable for resection, liver transplantation or percutaneous radiofrequency ablation;
- (3) Tumor thrombus, a low-attenuation intraluminal filling defect extending from intrahepatic portal vein branches adjacent to primary tumor into main portal vein, was confirmed by contrast-enhanced abdominal computer tomography (CT) or magnetic resonance imaging (MRI)
- (4) At least the first-order branch of the intrahepatic portal vein was patent in one lobe;
- (5) Child-Pugh classification grade A or B;
Key exclusion criteria (6 listed)
- (1) Patients had a history of any therapy for HCC or portal vein tumor thrombus;
- (2) Advanced liver disease (bilirubin levels >3 mg/dL, Aspartate transaminase or Alanine aminotransferase >5 × upper limit of normal)；
- (3) Tumor invade the Inferior Vena Cava, extrahepatic spread;
- (4) Any contraindication to an arterial procedure such as impaired clotting tests (platelet count below 50 × 109/L or prothrombin activity below 50 %);
- (5) 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 |
|---|---|---|
| Stent and Iodine-125 seed strand implantationThe patent second-order branch of the intrahepatic portal vein was punctured with a 22-gauge Chiba needle under ultrasound guidance.Stent and Iodine-125 seed strand are implanted by two 0.035-inch,150-cm-long wire. | Procedure or surgery | Endovascular Brachytherapy&Stent&TACE |
| StentBare stent should be placed through a 7-F, 23-cm-long sheath over the wire. | Device | Endovascular Brachytherapy&Stent&TACE |
| Iodine-125 seedThe number of Iodine-125 seeds planned to be implanted was calculated by the following formula: N = length of obstructed main portal vein (mm)/4.5 + 4. These seeds were arranged linearly and sealed into a 4-F catheter continuously to construct a Iodine-125 seed strand. | Device | Endovascular Brachytherapy&Stent&TACE |
| EpirubicinEpirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 30-60 mg per patient,depending on the situation of the patient. | Drug | Endovascular Brachytherapy&Stent&TACE, TACE alone |
| Ultra-fluid lipiodolAlso: lipiodolUltra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol . | Drug | Endovascular Brachytherapy&Stent&TACE, TACE alone |
| Gelatin sponge articlesGelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter. | Other | Endovascular Brachytherapy&Stent&TACE, TACE alone |
Primary outcome
Overall Survival
Time frame: From the date of randomization until the date of death from any cause, assessed up to 24 months
1 secondary outcome
Time To Progression
Time frame: From the date of first procedure of TACE or combined therapy until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Results publication: PubMed 21463757Luo J, Yan Z, Liu Q, Qu X, Wang J. Endovascular placement of iodine-125 seed strand and stent combined with chemoembolization for treatment of hepatocellular carcinoma with tumor thrombus in main portal vein. J Vasc Interv Radiol. 2011 Apr;22(4):479-89. doi: 10.1016/j.jvir.2010.11.029.
- Results publication: PubMed 26341514Luo JJ, Zhang ZH, Liu QX, Zhang W, Wang JH, Yan ZP. Endovascular brachytherapy combined with stent placement and TACE for treatment of HCC with main portal vein tumor thrombus. Hepatol Int. 2016 Jan;10(1):185-95. doi: 10.1007/s12072-015-9663-8. Epub 2015 Sep 4.
- Results publication: PubMed 24374800Yang M, Fang Z, Yan Z, Luo J, Liu L, Zhang W, Wu L, Ma J, Yang Q, Liu Q. Transarterial chemoembolisation (TACE) combined with endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus TACE alone: a two-arm, randomised clinical trial. J Cancer Res Clin Oncol. 2014 Feb;140(2):211-9. doi: 10.1007/s00432-013-1568-0. Epub 2013 Dec 28.
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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.
Zhiping 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 Stent and Iodine-125 seed strand implantation, Stent and Iodine-125 seed in people with Hepatocellular Carcinoma and Portal Vein Tumor Thrombus, 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 6 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zihan Zhang, MD (+8615901785843, zhangzihan0217@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From the date of randomization until the date of death from any cause, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02971345, which also lists 3 linked publications.
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 11 Jun 2020.