Carcinoma, HepatocellularHCCNCT01141478

Proton Radiotherapy Plus Sorafenib Versus Sorafenib for Patients With HCC Exceeding San Francisco Criteria

A study testing Proton Beam Radiotherapy and Sorafenib in people with Carcinoma, Hepatocellular, run by Loma Linda University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Carcinoma, Hepatocellular
What is being tested?: Proton Beam Radiotherapy and Sorafenib
Type of treatment: Pill or oral medicine, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 8 Sep 2010to 10 Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients are candidates to receive both proton beam and sorafenib
Patients with tumor burden that exceeds San Francisco criteria

Who cannot join

Patients who are candidates for surgical resection
Patients with tumor burden within Milan and/or San Francisco criteria
Patients who have contraindication to receive proton
Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
Patients treated previously by any locoregional treatment
Patients with prior liver transplant

Show all 14Show fewer

Patients with child class C
Patients with model for end-stage liver disease (MELD) score of > 25
Patients with other comorbid diseases that may impact survival
Patients with ongoing alcohol intake
Patients with active sepsis
Patients with gastrointestinal bleeding within a week
Patients unwilling to sign informed consent form
Patients with history of noncompliance

Trial locations and contacts

1 site in 1 country.

United States1 site

Loma Linda University Medical Center
Loma Linda, California, 92354

Other trials in United States

About this study

Official title: Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria

This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.

Conditions: Carcinoma, Hepatocellular
Being tested: Proton Beam Radiotherapy, Sorafenib
Keywords: Carcinoma, Hepatocellular, Proton Beam Radiotherapy, Sorafenib
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton Beam RadiotherapyRadiation
Fifteen consecutive sessions
SorafenibDrug
400 mg po bid

Study groups in NCT01141478
Study group	Role	What they receive
Proton Beam Radiotherapy plus Sorafenib	Active comparator	A combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth. Receives: Radiation: Proton Beam Radiotherapy; Drug: Sorafenib
Sorafenib	Active comparator	Sorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level. Receives: Drug: Sorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Survival Rate Between Time of Consent and Time of Death
All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.
Measured: Change between time of informed consent and primary completion date of study, an average of 4 years per participant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 201010 Jun 2016

First posted10 Jun 2010 (estimated)
Study start8 Sep 2010
Primary completion26 Dec 2014
Study completion10 Jun 2016

Why it stopped: due to low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
More trials run by Loma Linda 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01141478
Sponsor's protocol ID: 5100104
Acronym: HCC
Status last verified: Sep 2021
First submitted: 24 May 2010
Last updated: 15 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Carcinoma, Hepatocellular trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Proton Beam Radiotherapy + Sorafenib vs. Sorafenib for Patients With Hepatocellular Carcinoma Exceeding San Francisco Criteria
ClinicalTrials.gov ID: NCT01141478
Acronym / sponsor ID: HCC / 5100104
Conditions: Carcinoma, Hepatocellular
Keywords: Carcinoma, Hepatocellular, Proton Beam Radiotherapy, Sorafenib
Study type: Interventional
Recruitment status: TerminatedReason stopped: due to low enrollment
Enrolment: 8 participants (actual)
Lead sponsor: Loma Linda UniversityUniversity, hospital or other
Study start: 8 Sep 2010 (actual)
Primary completion: 26 Dec 2014 (actual)
Study completion: 10 Jun 2016 (actual)
First posted: 10 Jun 2010 (estimated)
Results: Posted 22 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study is designed to determine whether proton beam radiotherapy plus Sorafenib compared to Sorafenib alone will produce the best results for treating patients with Hepatocellular Carcinoma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Proton Beam Radiotherapy plus Sorafenib	Active comparator	Radiation: Proton Beam Radiotherapy, Drug: SorafenibA combination of radiation therapy (proton) to kill tumor cells as well as Sorafenib which is a study drug administered to patients to stop tumor growth.
Sorafenib	Active comparator	Drug: SorafenibSorafenib is an oral pill taken daily to inhibit tumor growth at the cellular level.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients are candidates to receive both proton beam and sorafenib
Patients with tumor burden that exceeds San Francisco criteria

Key exclusion criteria (14 listed)

Patients who are candidates for surgical resection
Patients with tumor burden within Milan and/or San Francisco criteria
Patients who have contraindication to receive proton
Patients with contraindication to receive sorafenib including uncontrolled hypertension, coumadin treatment and prior intolerability to the drug
Patients treated previously by any locoregional treatment

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 RadiotherapyFifteen consecutive sessions	Radiation	Proton Beam Radiotherapy plus Sorafenib
Sorafenib400 mg po bid	Drug	Proton Beam Radiotherapy plus Sorafenib, Sorafenib

Primary outcome

Overall Survival Rate Between Time of Consent and Time of Death
Time frame: Change between time of informed consent and primary completion date of study, an average of 4 years per participant
All subjects are to be followed from time of consent until time of death. Subjects in both arms will require either a CT scan or MRI of the abdomen every three months to monitor tumor progression. Follow up imaging with be the same modality used at baseline (CT or MRI). All subjects are to be evaluated in the liver clinic 4 weeks after treatment and then every 3 months. Subjects in the Proton arm will require a CT or MRI 4-6 weeks after treatment and then every three months. Subjects receiving Proton therapy will also be followed in the radiation medicine clinic by their treating radiation oncologist every 3 months for the first year and then every 6 months.

Results and safety

Results posted to the registry on 22 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Proton Beam Radiotherapy Plus Sorafenib	4	3
Sorafenib	4	3

Primary outcome: Overall Survival Rate Between Time of Consent and Time of Death

Time frame: Change between time of informed consent and primary completion date of study, an average of 4 years per participant. Mean (Full Range). Unit: years

Measure	Proton Beam Radiotherapy Plus Sorafenib n = 3	Sorafenib n = 3
Value	1.6 (0.1 to 3.7)	0.36 (0.3 to 0.4)

Population analysed: two subjects withdrew prior to over all survival rate measurement

Adverse events

Time frame: Adverse events were collected from time of enrollment to death or time when a patient was lost to follow-up. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Proton Beam Radiotherapy Plus Sorafenib	1 of 4 (25%)	0 of 4 (0%)	3 of 4
Sorafenib	0 of 4 (0%)	0 of 4 (0%)	3 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Carcinoma, Hepatocellular

RecruitingObservational study
Real-world Evaluation of the HistoSonics Edison System for Treatment of Liver Tumors Across Multidisciplinary Users (BOOMBOX: Master Study)
Liver Neoplasms, Primary Liver Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingObservational study
A Study to Evaluate Patient-Reported Satisfaction, Effectiveness, and Safety of Atezolizumab in Participants Treated in Routine Clinical Practice
Lung Cancer, Hepatocellular Carcinoma
RecruitingPhase 2
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Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma

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.

Michael deVera, MD principal investigator

Loma Linda University Medical Center

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 Radiotherapy and Sorafenib in people with Carcinoma, Hepatocellular, run by Loma Linda University at 1 site in United States.

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 2 inclusion and 14 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: stopped early, as of the sponsor's last update on 15 Oct 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 United States. 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?

Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Rate Between Time of Consent and Time of Death (time frame: Change between time of informed consent and primary completion date of study, an average of 4 years per participant). 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 NCT01141478.

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 15 Oct 2021.