The HEPANOVA trial (also known as the “EF-30 trial”) is a prospective (analogous to a drug Phase II), single arm, historical control study designed to test the overall response rate of Tumor Treating Fields (TTFields) in combination with sorafenib for patients with locally advanced liver cancer, which is not amenable to surgical resection or other treatments which target the specific tumor location. During the study, TTFields at 150 kHz are generated by a medical device, the NovoTTF-100L(P) System [About TTFields] , which is used by the patient at home. The trial is expected to enroll a total of 25 patients. The trial is now enrolling patients in multiple centers across Europe [HEPANOVA Centers].

The HEPANOVA Trial Design

Patients who were recently diagnosed with locally advanced liver (hepatocellular) cancer, and where surgical resection or loco-regional treatment is not possible are candidates for this trial. Loco-regional treatments are therapies such as radiation therapy or treatments which are delivered directly to the tumor using an arterial catheter. Final eligibility in the trial can only be determined by the clinical trial physician in one of the clinical trial centers. All patients enrolled in the trial will receive a standard of care treatment for their liver cancer with sorafenib (400 mg twice daily), similar to standard of care therapy for patients who are not participating in the trial.

Study treatment

The patient will receive continuous TTFields (150 kHz) treatment using the NovoTTF-100L(P) System concomitant to standard of care sorafenib (400 mg twice daily) . In order to apply the device, the patient needs to wear four Transducer Arrays taped on the abdomen, back and flanks. Transducer Array placement may require shaving of the abdomen/back before starting to use the device.  New sets of arrays will need to be applied twice a week for as long as the device is used.

The use of the device will start in an outpatient setting and will include training on the operation of the equipment by a qualified Novocure Device Support Specialist (DSS). Patients will continue to use the device at home [Living with TTFields]. Patients using the NovoTTF-100L(P) System can maintain the use of the device alone (with the help of a family member or a care giver if needed) or may receive support from their DSS.

The system is user-friendly and all technical aspects related to using it are maintained by the DSS. The DSS can also help patients in finding technical solutions, to allow each individual to receive TTFields while maintaining his/her normal daily routines.

Eligibility

For the complete list of eligibility criteria please go to clinicaltrials.gov or consult with a HEPANOVA trial physician:
Inclusion Criteria (summary, not complete list):

  1. New diagnosis of hepatocellular carcinoma in locally advanced stage where surgical resection or other loco-regional treatments are not possible.
  2. At least 18 years of age.

Exclusion Criteria (summary, not complete list):

  1. Other serious medical conditions, which will not allow the participation in the study
  2. High levels of serum DNA of hepatitis B virus without anti-viral therapy
  3. Implantable electrical medical devices in the torso, such as pacemakers or defibrillators

Enrollment

Expected total enrollment is 25 patients. The trial is currently open for enrollment in 1 medical center in Spain. Please contact the center as soon as possible if you would like to participate in the HEPANOVA trial.

 

Trial Costs

The trial sponsor (Novocure) will pay for reasonable technical treatment-related supplies, including the NovoTTF-100L(P) System and accessories. Patients and their insurance will be responsible for medical treatments received in the normal course of patient care. The trial sponsor will also reimburse patients for some travel costs related to the trial’s procedures. Such reimbursement can be done only according to the policy and approval of the trial center at which the patient is being treated. Please consult with the clinical trial team at the center prior to enrolling in the trial about the local reimbursement policy and your rights.