Liver NeoplasmPTHPNCT02571946
Proton Beam Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis
A study testing Proton beam therapy in people with Liver Neoplasm and Portal Vein Tumor Thrombosis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Neoplasm, Portal Vein Tumor Thrombosis, Proton Therapy
- What is being tested?
- Proton beam therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2015to Sep 2021
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatocellular carcinoma (HCC) patients
- pathologically proven
- HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline
- Portal vein tumor thrombosis (main, first branch, segmental)
- Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
- 20 or more age
Show all 13Show fewer
- Eastern Cooperative Oncology Group performance status 0 to 2 within 1 week before participate
- Adequate bone marrow function (absolute neutrophil count ≥ 1.0 x 109/l, platelet ≥ 30 x 109/l, hemoglobin ≥ 8 g/dl)
- Adequate liver/renal function within 1 week before participate
- Child-Pugh class A, B, or early C (score ≤ 10)
- Total bilirubin <3.0 mg/dL, Prothrombin time/International normalized ratio <1.7, Albumin≥2.8g/dL, Aspartate aminotransferase/alanine aminotransferase<6 times of upper normal limit
- Serum creatinine < 1,5 x upper normal limit, glomerular filtration rate > 50 ml/min Informed consent
- Women of childbearing potential and male participants must agree to practice adequate contraception while on study and for at least 6 months following the last dose of RT and for at least 28 days following the last dose of sorafenib (whichever is later).
Who cannot join
- Uncontrolled hepatic encephalopathy
- Previous history of upper abdominal radiotherapy
- Status of pregnancy or breast feeding
- Less than 12 weeks of expected survival
- Uncontrolled ascites
- Combined with disease known as radiosensitive disorder (connective tissue disorder, Ataxia-telangiectasia)
- Hard to maintain stable respiration less than 5 minutes related with respiratory disease
- Combined with uncontrolled severe acute disease other than liver
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of High Dose Proton Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Prospective Phase II Trial
The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Therefore, other loco-regional modalities, like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including portal vein tumor thrombosis (PVTT).
With the advancement of conformal RT techniques, RT was actively applied in HCC, especially in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.
Read more
Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.
In those background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients combined with PVTT.
- Conditions
- Liver Neoplasm, Portal Vein Tumor Thrombosis, Proton Therapy
- Being tested
- Proton beam therapy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton beam therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Proton beam therapy | Experimental | Not described Receives: Radiation: Proton beam therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
one-year overall survival
Measured: one-year after proton beam therapy
Secondary outcomes (13)
1 month objective response rate
Measured: 1 month after proton beam therapy
3 month objective response rate
Measured: 3 months after proton beam therapy
1 month portal vein tumor thrombosis response rate
Measured: 1 month after proton beam therapy
3 month portal vein tumor thrombosis response rate
Measured: 3 month after proton beam therapy
1 year progression free survival
Measured: one-year after proton beam therapy
1 year local progression free survival
Measured: one-year after proton beam therapy
1 year portal vein tumor thrombosis progression free survival
Measured: one-year after proton beam therapy
Adverse event
Measured: one-year after proton beam therapy
1 month Quality of life assessment compared with baseline
Measured: 1 month after proton beam therapy
3 month Quality of life assessment compared with baseline
Measured: 3 month after proton beam therapy
6 month Quality of life assessment compared with baseline
Measured: 6 month after proton beam therapy
Indocyanine green test change compared with baseline
Measured: 3 month after proton beam therapy
Hepatobiliary phase signal change after proton beam therapy
Measured: 3 month after proton beam therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2021
- Study completionSep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Proton beam radiotherapy
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Park Hee Chul, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571946
- Sponsor's protocol ID
- 2015-06-053
- Acronym
- PTHP
- Status last verified
- Nov 2023
- First submitted
- 7 Oct 2015
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Dose Proton Therapy in Hepatocellular Carcinoma With Portal Vein Tumor Thrombosis: Prospective Phase II Trial
- ClinicalTrials.gov ID
- NCT02571946
- Acronym / sponsor ID
- PTHP / 2015-06-053
- Conditions
- Liver Neoplasm, Portal Vein Tumor Thrombosis, Proton Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 8 Oct 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.
The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Therefore, other loco-regional modalities, like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including portal vein tumor thrombosis (PVTT).
With the advancement of conformal RT techniques, RT was actively applied in HCC, especially in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose.
Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively.
In those background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients combined with PVTT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proton beam radiotherapy
| Arm | Type | Receives |
|---|---|---|
| Proton beam therapy | Experimental | Radiation: Proton beam therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Hepatocellular carcinoma (HCC) patients
- pathologically proven
- HCC diagnosed based on American Association for the Study of Liver Diseases (AASLD) guideline
- Portal vein tumor thrombosis (main, first branch, segmental)
- Discussion in tumor board including gastroenterologist, radiologist, radiation oncologist
Key exclusion criteria (8 listed)
- Uncontrolled hepatic encephalopathy
- Previous history of upper abdominal radiotherapy
- Status of pregnancy or breast feeding
- Less than 12 weeks of expected survival
- Uncontrolled ascites
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 |
|---|---|---|
| Proton beam therapy | Radiation | Proton beam therapy |
Primary outcome
one-year overall survival
Time frame: one-year after proton beam therapy
13 secondary outcomes
1 month objective response rate
Time frame: 1 month after proton beam therapy
3 month objective response rate
Time frame: 3 months after proton beam therapy
1 month portal vein tumor thrombosis response rate
Time frame: 1 month after proton beam therapy
3 month portal vein tumor thrombosis response rate
Time frame: 3 month after proton beam therapy
1 year progression free survival
Time frame: one-year after proton beam therapy
1 year local progression free survival
Time frame: one-year after proton beam therapy
1 year portal vein tumor thrombosis progression free survival
Time frame: one-year after proton beam therapy
Adverse event
Time frame: one-year after proton beam therapy
1 month Quality of life assessment compared with baseline
Time frame: 1 month after proton beam therapy
3 month Quality of life assessment compared with baseline
Time frame: 3 month after proton beam therapy
6 month Quality of life assessment compared with baseline
Time frame: 6 month after proton beam therapy
Indocyanine green test change compared with baseline
Time frame: 3 month after proton beam therapy
Hepatobiliary phase signal change after proton beam therapy
Time frame: 3 month after proton beam therapy
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 22 Nov 2023.
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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 Proton beam therapy in people with Liver Neoplasm and Portal Vein Tumor Thrombosis, run by Samsung Medical Center at 1 site in South Korea.
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 13 inclusion and 8 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 22 Nov 2023. 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 South Korea. 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?
one-year overall survival (time frame: one-year after proton beam therapy). 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 22 Nov 2023.