Hepatocellular CarcinomaPhase 2NCT03606590
Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Sorafenib for Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA)
A Phase 2 study testing NovoTTF-100L(P) device and Sorafenib in people with Hepatocellular Carcinoma, run by NovoCure Ltd. at 8 sites in 6 countries.
Trial summary
The study is a prospective, phase II trial single arm, historical control aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L(P) System, in combination with sorafenib in patient with advanced HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- NovoTTF-100L(P) device and Sorafenib
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 8 sitesin 6 countries
- Study dates
- 15 Feb 2019to 14 Jan 2021
- Phase
- Phase 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
- HCC diagnosed by biopsy, or by imaging criteria (CT/MRI) and AFP
- ≥ 18 years of age
- Barcelona Clinic Liver Cancer Staging (BCLC) Stage 0-C
- Child-Turcotte-Pugh (CTP) score between 5 and 8 points
- Measurable disease per RECIST Criteria
- At least 4 weeks since major surgery
Show all 10Show fewer
- ECOG Performance Status (PS) of 0-2
- Life expectancy of at least 12 weeks
- All subjects must sign written informed consent
- Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver.
Who cannot join
- Patient candidate for surgical resection or local treatment (e.g. TACE, SIRT, RFTA, microwave, surgery)
- High levels of serum HBV DNA without anti-viral therapy
- Prior malignancy requiring anti-tumor treatment (apart from in-situ cervical cancer, in situ breast cancer, non-melanomatous skin cancers, or any malignancy for which treatment was received and there is no evidence of disease for at least 5 years) or concurrent malignancy.
- Significant co-morbidities within 4 weeks prior to enrollment, including the following:
- neurologic or psychiatric disorders such as dementia and uncontrolled seizures
- active, uncontrolled infections
Show all 16Show fewer
- active, disseminated coagulation disorder
- Significant renal impairment
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
- Chronic diarrhea
- History of any psychological or psychiatric condition that might impair the patient's ability to understand or comply with the requirements of the study or to provide consent.
- Other co-morbidities deemed by the investigator as such that may impact the compliance of the patient with the study protocol and follow up
- Implanted pacemaker, defibrillator or other electrical medical devices in the torso
- Known allergies to medical adhesives or hydrogel
- Pregnant or breast feeding (all patients of childbearing potential must use effective contraception method during the entire period of the study based on the recommendation of the investigator or a gynecologist)
- Admitted to an institution by administrative or court order
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Germany2 sites
University Medical Center - University of Freiburg
Freiburg im Breisgau, 79106
Ulm University Hospital
Ulm, 89081
Spain2 sites
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona
HM Hospitales - Centro Integral Oncológico Clara Campal
Madrid, 28050
Czechia1 site
University Hospital Fakultni Nemocnice Olomouc, Oncology Clinic
Olomouc, 779 00
Poland1 site
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, 61-701
About this study
Official title: HEPANOVA: a Phase II Trial of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
The study is a prospective, phase II trial single arm, historical control aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L(P) System, in combination with sorafenib in patient with advanced HCC. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Read the detailed description
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:
The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro hepatocellular carcinoma pre-clinical models. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In pilot study, 40 patients with locally advanced or metastatic pancreatic adenocarcinoma received chemotherapy with TTFields (150 kHz) applied to the abdomen. The combination was well tolerated and the only device-related adverse event was contact dermatitis.
In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2017).
DESCRIPTION OF THE TRIAL:
All patients included in this trial are patients with locally advanced hepatocellular carcinoma. In addition, all patients must meet all eligibility criteria.
Eligible patients will be enrolled, baseline tests will be performed and the patients will be treated continuously with the device concomitant with sorafenib until disease progression in the liver.
TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. Electrode array placement will require shaving of the abdomen/back as necessary before and during the treatment. After an initial short visit to the clinic for training and monitoring, patients will be released to continue treatment at home where they can maintain their regular daily routine.
During the trial the patient will need to return once every 4 weeks to the clinic where an examination by a physician and a routine laboratory examinations will be done. These routine visits will continue for as long as the patient's disease is not progressing in the liver. A routine CT or MRI scan of the abdomen will be performed at baseline and every 12 weeks thereafter, until disease progression in the liver. After this follow up plan, patients will be contacted once per month by telephone to answer basic questions about their health status.
SCIENTIFIC BACKGROUND:
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.
Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (150 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.
The breakthrough finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.
Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.
In conclusion, TTFields hold the promise of serving as a brand new treatment for hepatocellular carcinoma with very few side effects.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- NovoTTF-100L(P) device, Sorafenib
- Keywords
- Hepatocellular Carcinoma, Treatment, Minimal toxicity, TTFields, Tumor Treating Fields, Novocure, Sorafenib, Nexavar
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoTTF-100L(P) deviceDevice
Also called TTFields
Patients will be treated continuously with the NovoTTF-100L(P) device. NovoTTF-100L(P) treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. The treatment enables the patient to maintain regular daily routine.
SorafenibDrug
Also called Nexavar
Sorafenib 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal).
| Study group | Role | What they receive |
|---|---|---|
| TTFields in combination with sorafenib | Experimental | Patients will be treated continuously with TTFields, in addition to sorafenib Receives: Device: NovoTTF-100L(P) device; Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
The percentage of patients who had either complete response or partial response per RECIST criteria following enrollment in the trial.
Measured: 30 months
Secondary outcomes (7)
In-field control rate at one year
The percentage of patients who did not have progression confined to the right hypochondriac and epigastric anatomical regions (defined by the diaphragm as a superior border, the left midclavicular line as a lateral border and the subcostal plane as an inferior border) per RECIST criteria at one year following the time of enrollment in the trial, or death.
Measured: 12 months
Overall survival
The time from enrollment in the trial until date of death.
Measured: 30 months
Progression Free Survival
The time from enrollment in the trial until progression per RECIST Criteria or death.
Measured: 30 months
Distant metastases-free survival rate at 1 year
The percentage of patients who did not have new metastases outside of the liver (compared to the baseline CT/MRI) at one year following the time of enrollment in the trial, or death.
Measured: 12 months
Overall survival at one year
The percentage of patients who are alive at one year following the time of enrollment in the trial.
Measured: 12 months
Progression free survival at 6 and 12 months
the percentage of patients who are not progressive per RECIST Criteria, or dead at 6 and 12 months following the time of enrollment in the trial.
Measured: 12 months
Severity and frequency of adverse events
Incidence of adverse event out of the number of patients who receive at least 1 day of TTFields treatment.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start15 Feb 2019
- Primary completion14 Jan 2021
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoCure Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606590
- Sponsor's protocol ID
- EF-30
- Status last verified
- Nov 2024
- First submitted
- 23 Jul 2018
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
PubMed 15126372Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.
PubMed 17551011Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.
PubMed 22608262Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.
PubMed 19387848Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.
PubMed 26658786Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.
PubMed 26670971Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.
PubMed 29260225
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HEPANOVA: a Phase II Trial of Tumor Treating Fields (TTFields, 150kHz) Concomitant with Sorafenib for Advanced Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT03606590
- Acronym / sponsor ID
- EF-30
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, Treatment, Minimal toxicity, TTFields, Tumor Treating Fields, Novocure, Sorafenib, Nexavar
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- NovoCure Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 14 Jan 2021 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 31 Jul 2018 (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.
The study is a prospective, phase II trial single arm, historical control aimed to test the efficacy and safety of TTFields, using the NovoTTF-100L(P) System, in combination with sorafenib in patient with advanced HCC. The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
Detailed description
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:
The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro hepatocellular carcinoma pre-clinical models. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In pilot study, 40 patients with locally advanced or metastatic pancreatic adenocarcinoma received chemotherapy with TTFields (150 kHz) applied to the abdomen. The combination was well tolerated and the only device-related adverse event was contact dermatitis.
In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2017).
DESCRIPTION OF THE TRIAL:
All patients included in this trial are patients with locally advanced hepatocellular carcinoma. In addition, all patients must meet all eligibility criteria.
Eligible patients will be enrolled, baseline tests will be performed and the patients will be treated continuously with the device concomitant with sorafenib until disease progression in the liver.
TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. Electrode array placement will require shaving of the abdomen/back as necessary before and during the treatment. After an initial short visit to the clinic for training and monitoring, patients will be released to continue treatment at home where they can maintain their regular daily routine.
During the trial the patient will need to return once every 4 weeks to the clinic where an examination by a physician and a routine laboratory examinations will be done. These routine visits will continue for as long as the patient's disease is not progressing in the liver. A routine CT or MRI scan of the abdomen will be performed at baseline and every 12 weeks thereafter, until disease progression in the liver. After this follow up plan, patients will be contacted once per month by telephone to answer basic questions about their health status.
SCIENTIFIC BACKGROUND:
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.
Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (150 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.
The breakthrough finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.
Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.
In conclusion, TTFields hold the promise of serving as a brand new treatment for hepatocellular carcinoma with very few side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TTFields in combination with sorafenib | Experimental | Device: NovoTTF-100L(P) device, Drug: SorafenibPatients will be treated continuously with TTFields, in addition to sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HCC diagnosed by biopsy, or by imaging criteria (CT/MRI) and AFP
- ≥ 18 years of age
- Barcelona Clinic Liver Cancer Staging (BCLC) Stage 0-C
- Child-Turcotte-Pugh (CTP) score between 5 and 8 points
- Measurable disease per RECIST Criteria
Key exclusion criteria (16 listed)
- Patient candidate for surgical resection or local treatment (e.g. TACE, SIRT, RFTA, microwave, surgery)
- High levels of serum HBV DNA without anti-viral therapy
- Prior malignancy requiring anti-tumor treatment (apart from in-situ cervical cancer, in situ breast cancer, non-melanomatous skin cancers, or any malignancy for which treatment was received and there is no evidence of disease for at least 5 years) or concurrent malignancy.
- Significant co-morbidities within 4 weeks prior to enrollment, including the following:
- Implanted pacemaker, defibrillator or other electrical medical devices in the torso
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 |
|---|---|---|
| NovoTTF-100L(P) deviceAlso: TTFieldsPatients will be treated continuously with the NovoTTF-100L(P) device. NovoTTF-100L(P) treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. The treatment enables the patient to maintain regular daily routine. | Device | TTFields in combination with sorafenib |
| SorafenibAlso: NexavarSorafenib 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). | Drug | TTFields in combination with sorafenib |
Primary outcome
Overall response rate
Time frame: 30 months
The percentage of patients who had either complete response or partial response per RECIST criteria following enrollment in the trial.
7 secondary outcomes
In-field control rate at one year
Time frame: 12 months
Overall survival
Time frame: 30 months
Progression Free Survival
Time frame: 30 months
Distant metastases-free survival rate at 1 year
Time frame: 12 months
Overall survival at one year
Time frame: 12 months
Progression free survival at 6 and 12 months
Time frame: 12 months
Severity and frequency of adverse events
Time frame: 30 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 14 Nov 2024.
- Background: PubMed 15126372Kirson ED, Gurvich Z, Schneiderman R, Dekel E, Itzhaki A, Wasserman Y, Schatzberger R, Palti Y. Disruption of cancer cell replication by alternating electric fields. Cancer Res. 2004 May 1;64(9):3288-95. doi: 10.1158/0008-5472.can-04-0083.
- Background: PubMed 17551011Kirson ED, Dbaly V, Tovarys F, Vymazal J, Soustiel JF, Itzhaki A, Mordechovich D, Steinberg-Shapira S, Gurvich Z, Schneiderman R, Wasserman Y, Salzberg M, Ryffel B, Goldsher D, Dekel E, Palti Y. Alternating electric fields arrest cell proliferation in animal tumor models and human brain tumors. Proc Natl Acad Sci U S A. 2007 Jun 12;104(24):10152-7. doi: 10.1073/pnas.0702916104. Epub 2007 Jun 5.
- Background: PubMed 22608262Stupp R, Wong ET, Kanner AA, Steinberg D, Engelhard H, Heidecke V, Kirson ED, Taillibert S, Liebermann F, Dbaly V, Ram Z, Villano JL, Rainov N, Weinberg U, Schiff D, Kunschner L, Raizer J, Honnorat J, Sloan A, Malkin M, Landolfi JC, Payer F, Mehdorn M, Weil RJ, Pannullo SC, Westphal M, Smrcka M, Chin L, Kostron H, Hofer S, Bruce J, Cosgrove R, Paleologous N, Palti Y, Gutin PH. NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality. Eur J Cancer. 2012 Sep;48(14):2192-202. doi: 10.1016/j.ejca.2012.04.011. Epub 2012 May 18.
- Background: PubMed 19387848Kirson ED, Giladi M, Gurvich Z, Itzhaki A, Mordechovich D, Schneiderman RS, Wasserman Y, Ryffel B, Goldsher D, Palti Y. Alternating electric fields (TTFields) inhibit metastatic spread of solid tumors to the lungs. Clin Exp Metastasis. 2009;26(7):633-40. doi: 10.1007/s10585-009-9262-y. Epub 2009 Apr 23.
- Background: PubMed 26658786Giladi M, Schneiderman RS, Voloshin T, Porat Y, Munster M, Blat R, Sherbo S, Bomzon Z, Urman N, Itzhaki A, Cahal S, Shteingauz A, Chaudhry A, Kirson ED, Weinberg U, Palti Y. Mitotic Spindle Disruption by Alternating Electric Fields Leads to Improper Chromosome Segregation and Mitotic Catastrophe in Cancer Cells. Sci Rep. 2015 Dec 11;5:18046. doi: 10.1038/srep18046.
- Background: PubMed 26670971Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, Taylor LP, Lieberman F, Silvani A, Fink KL, Barnett GH, Zhu JJ, Henson JW, Engelhard HH, Chen TC, Tran DD, Sroubek J, Tran ND, Hottinger AF, Landolfi J, Desai R, Caroli M, Kew Y, Honnorat J, Idbaih A, Kirson ED, Weinberg U, Palti Y, Hegi ME, Ram Z. Maintenance Therapy With Tumor-Treating Fields Plus Temozolomide vs Temozolomide Alone for Glioblastoma: A Randomized Clinical Trial. JAMA. 2015 Dec 15;314(23):2535-43. doi: 10.1001/jama.2015.16669.
- Background: PubMed 29260225Stupp R, Taillibert S, Kanner A, Read W, Steinberg D, Lhermitte B, Toms S, Idbaih A, Ahluwalia MS, Fink K, Di Meco F, Lieberman F, Zhu JJ, Stragliotto G, Tran D, Brem S, Hottinger A, Kirson ED, Lavy-Shahaf G, Weinberg U, Kim CY, Paek SH, Nicholas G, Bruna J, Hirte H, Weller M, Palti Y, Hegi ME, Ram Z. Effect of Tumor-Treating Fields Plus Maintenance Temozolomide vs Maintenance Temozolomide Alone on Survival in Patients With Glioblastoma: A Randomized Clinical Trial. JAMA. 2017 Dec 19;318(23):2306-2316. doi: 10.1001/jama.2017.18718.
- Individual participant dataSharing planned: Undecided
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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.
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NovoTTF-100L(P) device and Sorafenib in people with Hepatocellular Carcinoma, run by NovoCure Ltd. at 8 sites in 6 countries.
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 10 inclusion and 16 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 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Spain, Czechia, France, Italy and 1 more country. 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 phase mean?
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.
What does the primary outcome measure?
Overall response rate (time frame: 30 months). 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 NCT03606590, which also lists 7 linked publications.
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 14 Nov 2024.