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 : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Device: NovoTTF-100L(P) device Drug: Sorafenib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||HEPANOVA: A Phase II Trial of Tumor Treating Fields (TTFields, 150kHz) Concomitant With Sorafenib For Advanced Hepatocellular Carcinoma (HCC)|
|Estimated Study Start Date :||December 2018|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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
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
- 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.
- 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.
- Overall survival [ Time Frame: 30 months ]The time from enrollment in the trial until date of death.
- Progression Free Survival [ Time Frame: 30 months ]The time from enrollment in the trial until progression per RECIST Criteria or death.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Lori A. Ladd||+1 603 389 email@example.com|
|Vall d'Hebron Institute of Oncology (VHIO)||Recruiting|
|Contact: Teresa Macarulla, Dr. +34-932748855 firstname.lastname@example.org|
|Contact: Raquel García Pelaez +34-934893000 email@example.com|
|Principal Investigator: Teresa Macarulla Mercade, Dr.|
|HM Hospitales - Centro Integral Oncológico Clara Campal||Recruiting|
|Madrid, Spain, 28050|
|Contact: Antonio Cubillo, Dr. firstname.lastname@example.org|
|Principal Investigator: email@example.com firstname.lastname@example.org, Dr.|