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Effect of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC) (HEPANOVA)

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ClinicalTrials.gov Identifier: NCT03606590
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
NovoCure Ltd. ( NovoCure GmbH )

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Device: NovoTTF-100L(P) device Drug: Sorafenib Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HEPANOVA: A Phase II Trial of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC)
Actual Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TTFields in combination with sorafenib
Patients will be treated continuously with TTFields, in addition to sorafenib
Device: NovoTTF-100L(P) device
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.
Other Name: TTFields

Drug: Sorafenib
Sorafenib 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal).
Other Name: Nexavar




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. In-field control rate at one year [ Time Frame: 12 months ]
    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.

  2. Overall survival [ Time Frame: 30 months ]
    The time from enrollment in the trial until date of death.

  3. Progression Free Survival [ Time Frame: 30 months ]
    The time from enrollment in the trial until progression per RECIST Criteria or death.

  4. Distant metastases-free survival rate at 1 year [ Time Frame: 12 months ]
    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.

  5. Overall survival at one year [ Time Frame: 12 months ]
    The percentage of patients who are alive at one year following the time of enrollment in the trial.

  6. Progression free survival at 6 and 12 months [ Time Frame: 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.

  7. Severity and frequency of adverse events [ Time Frame: 30 months ]
    Incidence of adverse event out of the number of patients who receive at least 1 day of TTFields treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. HCC diagnosed by biopsy, or by imaging criteria (CT/MRI) and AFP
  2. ≥ 18 years of age
  3. Barcelona Clinic Liver Cancer Staging (BCLC) Stage 0-C
  4. Child-Turcotte-Pugh (CTP) score between 5 and 8 points
  5. Measurable disease per RECIST Criteria
  6. At least 4 weeks since major surgery
  7. ECOG Performance Status (PS) of 0-2
  8. Life expectancy of at least 12 weeks
  9. All subjects must sign written informed consent
  10. Able to operate the NovoTTF-100L(P) System independently or with the help of a caregiver.

Exclusion Criteria:

  1. Patient candidate for surgical resection or local treatment (e.g. TACE, SIRT, RFTA, microwave, surgery)
  2. High levels of serum HBV DNA without anti-viral therapy
  3. 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.
  4. Significant co-morbidities within 4 weeks prior to enrollment, including the following:

    1. neurologic or psychiatric disorders such as dementia and uncontrolled seizures
    2. active, uncontrolled infections
    3. active, disseminated coagulation disorder
    4. Significant renal impairment
    5. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia)
    6. Chronic diarrhea
    7. 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.
    8. Other co-morbidities deemed by the investigator as such that may impact the compliance of the patient with the study protocol and follow up
  5. Implanted pacemaker, defibrillator or other electrical medical devices in the torso
  6. Known allergies to medical adhesives or hydrogel
  7. 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)
  8. Admitted to an institution by administrative or court order

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606590


Contacts
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Contact: Antonia Mahnig +41 41 455 36 32 clinicaltrials@novocure.com

Locations
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France
CHU de Nantes Recruiting
Nantes Cedex 01, France, 44093
Contact: Yann Touchefeu, Dr.       Yann.TOUCHEFEU@chu-nantes.fr   
Principal Investigator: Yann Touchefeu, Dr.         
Germany
University Medical Center - University of Freiburg Recruiting
Freiburg, Germany, 79106
Contact: Anca-Ligia Grosu, Prof. Dr.       anca.grosu@uniklinik-freiburg.de   
Principal Investigator: Anca-Ligia Grosu, Prof. Dr.         
Italy
Università Campus Bio-Medico di Roma Recruiting
Rome, Italy, 00128
Contact: Bruno Vincenzi, Dr.       b.vincenzi@unicampus.it   
Principal Investigator: Bruno Vincenzi, Dr.         
Spain
Vall d'Hebron Institute of Oncology (VHIO) Recruiting
Barcelona, Spain
Contact: Teresa Macarulla, Dr.    +34-932748855    tmacarulla@vhio.net   
Contact: Raquel García Pelaez    +34-934893000    rgarcia@vhio.net   
Principal Investigator: Teresa Macarulla Mercade, Dr.         
HM Hospitales - Centro Integral Oncológico Clara Campal Recruiting
Madrid, Spain, 28050
Contact: Antonio Cubillo, Dr.       acubillo@hmhospitales.com   
Principal Investigator: acubillo@hmhospitales.com acubillo@hmhospitales.com, Dr.         
Sponsors and Collaborators
NovoCure GmbH

Publications:

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Responsible Party: NovoCure GmbH
ClinicalTrials.gov Identifier: NCT03606590     History of Changes
Other Study ID Numbers: EF-30
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NovoCure Ltd. ( NovoCure GmbH ):
Hepatocellular Carcinoma
Treatment
Minimal toxicity
TTFields
Tumor Treating Fields
Novocure
Sorafenib
Nexavar
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action