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Small Molecule

Regorafenib for Liver Cancer

Phase 2
Waitlist Available
Led By William Blackstock, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must not have curative treatment options, including surgery or radiofrequency ablation, available.
Other anti-cancer treatments are not permitted during this study, including alternative medicine and herbal therapies.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4 months and at 6 months from the date of enrollment
Awards & highlights

Study Summary

This trial is testing whether adding electromagnetic fields to the drug Regorafenib can help people with liver cancer live longer without the cancer growing, compared to people who just take Regorafenib.

Eligible Conditions
  • Liver Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4 months and at 6 months from the date of enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 4 months and at 6 months from the date of enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival
Secondary outcome measures
Change in Alpha-fetoprotein Levels
Comparison of Adverse Events (WFBCCC 55319 to RESORCE historical trial)
Incidences of Adverse Events
+2 more

Side effects data

From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607
82%
Diarrhoea
76%
Nausea
71%
Fatigue
57%
Vomiting
53%
Abdominal pain
30%
Neuropathy peripheral
27%
Dyspnoea
25%
Anaemia
23%
Neutrophil count decreased
23%
Constipation
22%
Weight decreased
21%
Hypokalaemia
20%
Oedema peripheral
18%
Dehydration
17%
Cough
17%
Neutropenia
17%
Pyrexia
17%
Peripheral sensory neuropathy
16%
Thrombocytopenia
15%
Platelet count decreased
15%
Back pain
13%
Mucosal inflammation
13%
Temperature intolerance
13%
Dysgeusia
13%
Chromaturia
12%
White blood cell count decreased
12%
Urinary tract infection
11%
Dizziness
11%
Depression
10%
Hyponatraemia
10%
Stomatitis
10%
Ascites
10%
Dysphagia
10%
Anxiety
9%
Headache
9%
Abdominal distension
9%
Insomnia
8%
Arthralgia
8%
Asthenia
8%
Pain in extremity
8%
Alopecia
7%
Urine ketone body present
7%
Blood alkaline phosphatase increased
7%
Pulmonary embolism
6%
Lymphopenia
6%
Leukopenia
6%
Blood bilirubin increased
6%
Dyspepsia
5%
Sepsis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Hypertension
5%
Urine leukocyte esterase positive
5%
Abdominal pain upper
5%
Gastrooesophageal reflux disease
5%
Proteinuria
5%
Rash
4%
Flatulence
4%
Chills
3%
Dry mouth
3%
Myalgia
3%
Epistaxis
3%
Muscle spasms
2%
Pneumonia
2%
pelvic fracture
2%
Haematemesis
2%
Disease progression
2%
Pleural effusion
2%
Confusional state
2%
Mental status changes
2%
malignant neoplasm progression
1%
pancreatic carcinoma
1%
Lung abscess
1%
Oesophagitis
1%
Large intestine perforation
1%
embolism
1%
fall
1%
Death
1%
Haemorrhage intranial
1%
Atrial fibrillation
1%
Colitis
1%
Enterocutaneous fistula
1%
Gastrointestinal haemorrhage
1%
Upper gastrointestinal haemorrhage
1%
Chest pain
1%
somnolence
1%
syncope
1%
Febrile neutropenia
1%
Acute kidney injury
1%
Acute respiratory failure
1%
Hypoxia
1%
Pneumonia aspiration
1%
Clostridium difficile colitis
1%
Influenza
1%
Perirectal abscess
1%
Salmonella sepsis
1%
Septic shock
1%
hip fracture
1%
deep vein thrombosis
1%
haematoma
1%
pelvic venous thrombosis
1%
Cholangitis
1%
Ischaemic cerebral infarction
1%
Hyperglycaemia
1%
subdural haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Napabucasin Plus FOLFOX6
Napabucasin Plus FOLFOX6 Plus Bevacizumab
Napabucasin Plus FOLFIRI Plus Bevacizumab
Napabucasin Plus Regorafenib
Napabucasin Plus FOLFIRI
Napabucasin Plus Irinotecan
Napabucasin Plus CAPOX

Trial Design

1Treatment groups
Experimental Treatment
Group I: Regorafenib and TheraBionicExperimental Treatment2 Interventions
TheraBionic is a device that consists of battery-driven radiofrequency electromagnetic field generator. The metal mouth spoon antenna is placed on the anterior part of the tongue during treatment. Regorafenib is a 40 mg tablet administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Regorafenib
2014
Completed Phase 2
~1580

Find a Location

Who is running the clinical trial?

TheraBionic, Inc.UNKNOWN
1 Previous Clinical Trials
166 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,158 Total Patients Enrolled
4 Trials studying Liver Cancer
208 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,128 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this an unprecedented research endeavor?

"Currently, Regorafenib is the subject of 58 ongoing investigations in 418 cities and 30 nations. This drug was first trialled by Bayer in 2014 with 38 participants, attaining Phase 2 approval. Since then, a further 82 examinations have been executed."

Answered by AI

What ailments can Regorafenib be employed to combat?

"Patients who have received anti-VEGF therapy, established advanced directives, and were prescribed Sorafenib can be administered Regorafenib to treat their condition."

Answered by AI

Has the FDA sanctioned Regorafenib for use?

"Regorafenib has been classified with a safety score of 2 due to the limited evidence supporting its efficacy, although there is some proof that it can be used without major risk."

Answered by AI

What is the upper limit for individuals participating in this medical study?

"Affirmative. Clinicaltrials.gov has records that this research is actively enrolling patients, with the first posting having been made on January 26th 2021 and being updated as recently as October 26th 2022. 25 participants are needed to be recruited from 1 medical site."

Answered by AI

Are there any extant reports pertaining to the efficacy of Regorafenib?

"At present, Regorafenib is the subject of 58 ongoing trials with 7 at Phase 3. Most are located in Commack, New york; however 1205 other sites have also launched research initiatives for this medication."

Answered by AI

Are there any vacant slots for participants in this trial?

"Affirmative. According to clinicaltrials.gov, this research endeavour was first shared on January 26th 2021 and is actively seeking volunteers for participation. 25 recruits are being sought out from a single medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib
2021. "Study Of Intrabucally Administered Electromagnetic Fields and Regorafenib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04327700.
~0 spots leftby May 2024
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