Advanced Hepatocellular CarcinomaPhase 1/2TheraBionicNCT00534664
Phase I/II Study of Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
A Phase 1/2 study testing TheraBionic device in people with Advanced Hepatocellular Carcinoma, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- TheraBionic device
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2005to Feb 2007
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced biopsy-proven HCC
- Performance status ECOG 0-1
- Patients with Child Pugh A and B cirrhosis scores
- Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate.
- Presence of one or more measurable lesion(s) according to the RECIST criteria.
- Lesions treated with chemoembolization or ablation by means of radio frequencies will not be considered measurable in this study.
Show all 16Show fewer
- Patients on a liver transplant waiting list may be included
- Patient must not have curative treatment options other than liver transplant
- Patient may have been treated with intrahepatic treatment (chemoembolization or intrahepatic chemotherapy) or conventional chemotherapy or sorafenib or other experimental therapies prior to study entry. There is no limit for the number of prior therapies
- Extra hepatic metastases do not constitute an exclusion criterion, except for active CNS metastases.
- At least 4 weeks must have elapsed since administration of any anti-cancer treatment.
- Other anti-cancer treatments are not permitted during this study
- Patients must be more than 18 old and must be able to understand and sign an informed consent.
- Patient must agree to be followed up according to the study protocol.
- Patients may have either stable disease or disease progression according to the principal investigator assessment.
- Patients who carry a pacemaker or any other implantable electronic device are not allowed in the study
Who cannot join
- Suspected or biopsy confirmed brain metastases
- Patients with hepatic cirrhosis with Child-Pugh class C
- Patients who have received a liver transplant.
- Patients who had a surgical resection of the disease and who do not have measurable disease.
- Pregnant women
- Patients who still show objective response (complete or partial response) according to the RECIST criteria due to the last anti-cancer therapy
- Patients diagnosed with another type of cancer (excluding basal cell carcinoma) during the last five last years or whose cancer diagnosed previously is not in remission
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Disciplina de Transplante e Cirurgia do Fígado
São Paulo, São Paulo, 05403-000
About this study
Official title: Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
The goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- TheraBionic device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraBionic deviceDevice
Daily outpatient treatment with theraBionic device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Frederico P Costa, MD, Principal investigator, Disciplina de Transplante e Cirurgia do Fígado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534664
- Sponsor's protocol ID
- THBC-HCC-01
- Acronym
- TheraBionic
- Status last verified
- Sep 2007
- First submitted
- 24 Sep 2007
- Last updated
- 26 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Determine the Effectiveness of Intrabuccally Administered Amplitude-Modulated Electromagnetic Fields in the Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00534664
- Acronym / sponsor ID
- TheraBionic / THBC-HCC-01
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Oct 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 26 Sep 2007 (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 goal of this study is to investigate the safety and feasibility of treating patients with advanced hepatocellular carcinoma with a noninvasive device administering low level of amplitude-modulated electromagnetic fields.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Advanced biopsy-proven HCC
- Performance status ECOG 0-1
- Patients with Child Pugh A and B cirrhosis scores
- Absence of medical or psychiatric contraindication which, in the opinion of the treating investigator, would make the patient's participation in this trial inappropriate.
- Presence of one or more measurable lesion(s) according to the RECIST criteria.
Key exclusion criteria (7 listed)
- Suspected or biopsy confirmed brain metastases
- Patients with hepatic cirrhosis with Child-Pugh class C
- Patients who have received a liver transplant.
- Patients who had a surgical resection of the disease and who do not have measurable disease.
- Pregnant women
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 |
|---|---|---|
| TheraBionic deviceDaily outpatient treatment with theraBionic device | Device | – |
Primary outcome
Not reported in the source record.
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 26 Sep 2007.
Related trials for Advanced Hepatocellular Carcinoma
RecruitingPhase 1
A Study of MGC026 in Participants With Advanced Solid Tumors
Advanced Solid Tumor, Advanced Cancer
Not yet recruitingPhase 1
Study of ACC-1898 in Adult Participants With Advanced Solid Tumors
Hepatocellular Carcinoma, Renal Cell Carcinoma
RecruitingPhase 1
A Study to Evaluate ALN-BCAT in Patients With Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
Advanced Solid Tumors, Ewing Sarcoma
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Frederico P Costa, MD principal investigator
Disciplina de Transplante e Cirurgia do Fígado
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TheraBionic device in people with Advanced Hepatocellular Carcinoma, run by University of Sao Paulo at 1 site in Brazil.
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 16 inclusion and 7 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 26 Sep 2007. 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 Brazil. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 26 Sep 2007; AzTrials last refreshed its copy on 1 Nov 2026.