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

NCT03606590 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-11-14

No results posted yet for this study

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.

Conditions

Interventions

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.

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).

Sponsors & Collaborators

  • NovoCure Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2021-01-14
Completion
2021-01-14

Countries

  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03606590 on ClinicalTrials.gov