HCCNCT03108248
ISP-TACE Versus TACE for HCC With PVTT
An observational study of HCC and Portal Vein Tumor Thrombosis, run by Zhongda Hospital at 1 site in China.
Trial summary
For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- HCC, Portal Vein Tumor Thrombosis
- What is being tested?
- ethiodized oil; doxorubicin;Gelfoam; and stent; idoine-125
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 25 Mar 2017
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Between January 2011 and December 2016, patients with HCC and PVTT underwent TACE combined with irradiation stent placement or TACE monotherapy as an initial treatment at the authors' center were retrospectively reviewed.
Who may be able to join
- (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
Who cannot join
- (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Survival Benefit of Transarterial Chemoembolization in Combination With Irradiation Stent Placement
For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.
- Conditions
- HCC, Portal Vein Tumor Thrombosis
- Being tested
- ethiodized oil; doxorubicin;Gelfoam;, stent; idoine-125
- Keywords
- transarterial chemoembolization, stent, irradiation, survival, decompensation, tumor response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ethiodized oil; doxorubicin;Gelfoam;Drug
Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.
stent; idoine-125Device
In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath.
| Study group | Role | What they receive |
|---|---|---|
| ISP-TACE group | During the study period, a total of 44 patients with HCC with PVTT underwent the irradiation stent placement and TACE were included in the ISP-TACE group. Receives: Drug: ethiodized oil; doxorubicin;Gelfoam; | |
| TACE group | During the study period, a total of 82 patients with HCC with PVTT underwent TACE monotherapy were included in the ISP-TACE group. Receives: Drug: ethiodized oil; doxorubicin;Gelfoam;; Device: stent; idoine-125 |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival
The overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up
Measured: 0-6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start1 Jan 2011
- Primary completion12 Dec 2016
- Study completion25 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCCStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gao-jun Teng, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108248
- Sponsor's protocol ID
- ZhongdaHP
- Status last verified
- Apr 2017
- First submitted
- 4 Apr 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Survival Benefit of Transarterial Chemoembolization in Combination With Irradiation Stent Placement
- ClinicalTrials.gov ID
- NCT03108248
- Acronym / sponsor ID
- ZhongdaHP
- Conditions
- HCC, Portal Vein Tumor Thrombosis
- Keywords
- transarterial chemoembolization, stent, irradiation, survival, decompensation, tumor response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 12 Dec 2016 (actual)
- Study completion
- 25 Mar 2017 (actual)
- First posted
- 11 Apr 2017 (actual)
- 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.
For patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT), the survival benefit of transarterial chemoembolization (TACE) remains modest. This study aimed to investigate whether TACE in combination with irradiation stent placement (ISP) could prolong the survival in patients with HCC and PVTT.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISP-TACE group | – | Drug: ethiodized oil; doxorubicin;Gelfoam;During the study period, a total of 44 patients with HCC with PVTT underwent the irradiation stent placement and TACE were included in the ISP-TACE group. |
| TACE group | – | Drug: ethiodized oil; doxorubicin;Gelfoam;, Device: stent; idoine-125During the study period, a total of 82 patients with HCC with PVTT underwent TACE monotherapy were included in the ISP-TACE group. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Between January 2011 and December 2016, patients with HCC and PVTT underwent TACE combined with irradiation stent placement or TACE monotherapy as an initial treatment at the authors' center were retrospectively reviewed.
Key inclusion criteria (1 listed)
- (1) newly diagnosed HCC with type II or III PVTT, (2) Child-Pugh classification grade A or B, (3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2.
Key exclusion criteria (1 listed)
- (1) type I or IV PVTT, (2) received sorafenib, systemic chemotherapy, or external radiotherapy during the treatment, (3) suffered from malignancy other than HCC, (4) with an incomplete data.
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 |
|---|---|---|
| ethiodized oil; doxorubicin;Gelfoam;Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles. | Drug | ISP-TACE group, TACE group |
| stent; idoine-125In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath. | Device | TACE group |
Primary outcome
survival
Time frame: 0-6 years
The overall survival (OS) was defined as the time from first treatment to death or the patient's last follow up
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 11 Apr 2017.
Related trials for HCC
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
Not yet recruitingPhase 3
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
Hepatocellular Carcinoma
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 2
An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCC
Hepato Cellular Carcinoma (HCC), Immune Checkpoint Inhibitor
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?
An observational study of HCC and Portal Vein Tumor Thrombosis, run by Zhongda 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 1 inclusion and 1 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 11 Apr 2017. 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?
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?
survival (time frame: 0-6 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 11 Apr 2017.