Hepatocellular Carcinoma Non-resectableNCT04966195
Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
A study testing stereotactic body raiotherapy in people with Hepatocellular Carcinoma Non-resectable and Portal Vein Tumor Thrombosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombosis, Stereotactic Body Radiotherapy
- What is being tested?
- stereotactic body raiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2015to 30 Aug 2018
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
- an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2; 3. no refractory ascites;
- 4. Child-Pugh class A and B, or class C with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver
Who cannot join
- Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
- Diffuse HCC or accompanied by distant metastasis;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Patients with a history of hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
China1 site
the second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
About this study
Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.
- Conditions
- Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombosis, Stereotactic Body Radiotherapy
- Being tested
- stereotactic body raiotherapy
- Keywords
- Hepatocellular carcinoma, Portal vein tumor thrombosis, Stereotactic body radiotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body raiotherapyRadiation
stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
| Study group | Role | What they receive |
|---|---|---|
| radiotherapy | Other | stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis Receives: Radiation: stereotactic body raiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The time from the patient received treatment to died from any cause
Measured: from enrollment to death (for any reason).assessed up to 12 months
Secondary outcomes (1)
objective response rate
complete or partial response after treatment
Measured: from enrollment to progression or death (for any reason),assessed up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start1 Dec 2015
- Primary completion30 Jun 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966195
- Sponsor's protocol ID
- (2016)-050
- Status last verified
- Jun 2017
- First submitted
- 11 Jul 2021
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stereotactic Body Radiotherapy Based Treatment for Hepatocellular Carcinoma With Extensive Portal Vein Tumor Thrombosis
- ClinicalTrials.gov ID
- NCT04966195
- Acronym / sponsor ID
- (2016)-050
- Conditions
- Hepatocellular Carcinoma Non-resectable, Portal Vein Tumor Thrombosis, Stereotactic Body Radiotherapy
- Keywords
- Hepatocellular carcinoma, Portal vein tumor thrombosis, Stereotactic body radiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 19 Jul 2021 (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.
Macrovascular invasion (MVI) is common in HCC, Portal vein tumor thrombus (PVTT) is the most common form of MVI in HCC, with an incidence ranging from 44 to 62.2%. About 10% to 60% of HCC patients have PVTT at the time of diagnosis. the prognosis for those with PVTT remains poor, as their median survival is only 2-4 months via supportive care. There is currently no widely-accepted consensus for the management of HCC with PVTT. According to some guidelines in Europe and America, HCC with PVTT is regarded as Stage C per Barcelona Clinic Liver Cancer (BCLC) Staging system, and sorafenib alone is recommended as the treatment of choice. This study is to analyze the safety and efficacy of radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
| Arm | Type | Receives |
|---|---|---|
| radiotherapy | Other | Radiation: stereotactic body raiotherapystereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- tumor thrombus involving the main trunk and/or first branches of the portal vein, unsuitable for surgery or TACE;
- an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2; 3. no refractory ascites;
- 4. Child-Pugh class A and B, or class C with good performance status; 5. no previous radiotherapy to the liver; 6. more than 700 cc of uninvolved liver
Key exclusion criteria (4 listed)
- Have received local or systemic treatments in the past, including but not limited to TACE, immunotherapy, targeted therapy, radiotherapy, radiofrequency therapy, etc.;
- Diffuse HCC or accompanied by distant metastasis;
- Severe bleeding tendency or coagulation dysfunction within the previous 6 months;
- Patients with a history of hepatic encephalopathy
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 |
|---|---|---|
| stereotactic body raiotherapystereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis | Radiation | radiotherapy |
Primary outcome
overall survival
Time frame: from enrollment to death (for any reason).assessed up to 12 months
The time from the patient received treatment to died from any cause
1 secondary outcome
objective response rate
Time frame: from enrollment to progression or death (for any reason),assessed up to 12 months
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 19 Jul 2021.
- Individual participant dataSharing planned: No
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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 study testing stereotactic body raiotherapy in people with Hepatocellular Carcinoma Non-resectable and Portal Vein Tumor Thrombosis, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 4 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 19 Jul 2021. 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?
overall survival (time frame: from enrollment to death (for any reason).assessed up to 12 months). 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 Jul 2021.