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Tyrosine Kinase Inhibitor
Cabozantinib S-malate for Liver Cancer
Phase 2
Waitlist Available
Led By Kaylyn Kit Man Wong
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a histologically confirmed diagnosis of HCC or a non-invasive diagnosis of HCC as per the American Association for the Study of Liver Diseases (AASLD) criteria
If available, archival tissue must be submitted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, every 2 cycles until cycle 4, then every 3 cycles until disease progression, up to 10 months 16 days.
Awards & highlights
Study Summary
This trial is testing whether a cancer drug and immunotherapy drug work better together than either drug alone to treat patients with advanced liver cancer.
Eligible Conditions
- Liver Cancer
- Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, every 2 cycles until cycle 4, then every 3 cycles until disease progression, up to 10 months 16 days.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, every 2 cycles until cycle 4, then every 3 cycles until disease progression, up to 10 months 16 days.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants With Objective Response (Complete or Partial Response)
Secondary outcome measures
Number of Participants With Adverse Events
Number of Participants With Disease Control (Complete + Partial Response + Stable Disease)
Overall Survival Time in Months
+1 moreSide effects data
From 2019 Phase 2 trial • 13 Patients • NCT0231543085%
Fatigue
77%
Nausea
62%
Dysgeusia
62%
Vomiting
54%
Alkaline Phosphatase Increased
54%
Aspartate Aminotransferase Increased
54%
Mucositis Oral
54%
Abdominal Pain
46%
Hypertension
46%
Anorexia
38%
Alanine Aminotransferase Increased
38%
Thromboembolic Event
38%
Anemia
38%
Diarrhea
38%
Constipation
38%
Cough
38%
Weight Loss
38%
Dyspnea
31%
Hypomagnesemia
31%
Back Pain
31%
Lipase Increased
31%
Hypoalbuminemia
23%
Hypophosphatemia
23%
Hyperglycemia
23%
Dizziness
23%
Palmar-Plantar Erythrodysesthesia Syndrome
23%
Alopecia
23%
Hypothyroidism
23%
Pain In Extremity
23%
Oral Pain
23%
Pain
23%
Headache
15%
Sore Throat
15%
Activated Partial Thromboplastin Time Prolonged
15%
Myalgia
15%
Bloating
15%
White Blood Cell Decreased
15%
Insomnia
15%
Dry Mouth
15%
Dyspepsia
15%
Dehydration
15%
Hypocalcemia
15%
Dry Skin
15%
Flushing
15%
Peripheral Sensory Neuropathy
15%
Abdominal Distension
15%
Platelet Count Decreased
8%
Generalized Muscle Weakness
8%
Allergic Rhinitis
8%
Creatinine Increased
8%
Hyponatremia
8%
Flank Pain
8%
Bone Pain
8%
Gastroesophageal Reflux Disease
8%
Chest Pain - Cardiac
8%
Vertigo
8%
Neutrophil Count Decreased
8%
Arthralgia
8%
Syncope
8%
Proteinuria
8%
Pleural Effusion
8%
Nasal Congestion
8%
Pleuritic Pain
8%
Hoarseness
8%
Nail Discoloration
8%
Ventricular Tachycardia
8%
Tinnitus
8%
Gastrointestinal Pain
8%
Floaters
8%
Dysphagia
8%
Blood Bilirubin Increased
8%
Lung Infection
8%
Fever
8%
Depression
8%
Hypersomnia
8%
Hypotension
8%
Productive Cough
8%
Memory Impairment
8%
Anxiety
8%
Cardiac Troponin I Increased
8%
Urinary Incontinence
8%
Pancreatitis
8%
Upper Respiratory Infection
8%
Bruising
8%
Weight Gain
8%
Skin Induration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cabozantinib
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cabozantinib S-malate, pembrolizumab)Experimental Treatment2 Interventions
Patients receive cabozantinib S-malate PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib S-malate
2013
Completed Phase 2
~470
Pembrolizumab
2017
Completed Phase 2
~1950
Find a Location
Who is running the clinical trial?
ExelixisIndustry Sponsor
116 Previous Clinical Trials
18,084 Total Patients Enrolled
1 Trials studying Liver Cancer
University of WashingtonLead Sponsor
1,728 Previous Clinical Trials
1,840,927 Total Patients Enrolled
1 Trials studying Liver Cancer
1,000 Patients Enrolled for Liver Cancer
Kaylyn Kit Man WongPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
1 Previous Clinical Trials
37 Total Patients Enrolled
Frequently Asked Questions
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