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Tyrosine Kinase Inhibitor

Cabozantinib for Liver Cancer

Phase 2
Recruiting
Led By Jennifer Knox, M.D.
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC)
Not amenable to curative surgery or local treatment for recurrent disease
Must not have
Receiving any other investigational agents
Had systemic therapy or radiotherapy <3 weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

This trial tests cabozantinib in patients with liver cancer who had a liver transplant but whose cancer has returned. Cabozantinib works by blocking proteins that help cancer cells grow. The goal is to see if this drug can control the disease in these patients.

Who is the study for?
Adults who've had a liver transplant to treat hepatocellular carcinoma (liver cancer) but now have recurrence. They should not have tried cabozantinib before, may have had one prior therapy for advanced cancer, and must be able to swallow pills. Excluded are those with recent treatments, other serious health issues like infections or heart problems, pregnant women, or anyone with conditions that might interfere with the trial.
What is being tested?
The study is testing cabozantinib's effectiveness in controlling recurrent liver cancer after a transplant. It targets proteins involved in tumor growth. Participants will take this drug until it stops working for them or side effects become too severe.
What are the potential side effects?
Cabozantinib can cause hand-foot skin reactions, diarrhea, weight loss due to decreased appetite, fatigue, high blood pressure and mouth sores. More serious side effects could include bleeding complications and holes in the stomach or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You had a liver transplant in the past to treat liver cancer.
Select...
Your cancer cannot be treated with surgery or other local treatments that can cure it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease control rate
Secondary study objectives
Number of Side Effects Reported
Overall survival
Progression-free survival

Side effects data

From 2022 Phase 2 trial • 45 Patients • NCT02101736
95%
HYPOTHYROIDISM
73%
DIARRHEA
55%
WEIGHT LOSS
50%
FATIGUE
41%
ANOREXIA
41%
ALANINE AMINOTRANSFERASE INCREASED
41%
Neutrophil Count Decreased
41%
ASPARTATE AMINOTRANSFERASE INCREASED
41%
VOMITING
41%
NAUSEA
36%
HEADACHE
36%
PALMAR-PLANTAR ERYTHRODYSESTHESIA SYNDROME
36%
PAIN IN EXTREMITY
36%
HYPERTENSION
32%
PROTEINURIA
32%
PAIN
27%
White Blood Cell Count Decreased
27%
ABDOMINAL PAIN
23%
PLATELET COUNT DECREASE
23%
HYPONATREMIA
23%
Renal & Urinary Disorders - Other, Ketonuria
23%
Decreased Platelet Count
23%
Platelet Count Decreased
23%
Skin Hypopigmentation
23%
HAIR COLOR CHANGE
18%
HEMOGLOBIN INCREASED
18%
HYPOKALEMIA
18%
Upper Respiratory Infection
18%
HYPOPHOSPHATEMIA
18%
Alopecia
18%
Hyperkalemia
14%
HYPOGLYCEMIA
14%
Pruritis
14%
HYPERGLYCEMIA
14%
BILIRUBIN INCREASED
14%
ACNEIFORM RASH
14%
Cough
14%
Blood Bilirubin Increased
14%
DIZZINESS
14%
Rash Acneiform
14%
Rash Maculopapular
14%
Skin And Subcutaneous Disorders - Other, Achromotricia
14%
CONSTIPATION
14%
Fever
9%
TUMOR PAIN
9%
Papulopustular Rash
9%
ALKALINE PHOSPHATASE INCREASED
9%
Creatinine Increased
9%
Back Pain
9%
ABSOLUTE NEUTROPHIL COUNT DECREASED
9%
LIPASE INCREASED
9%
Paresthesia
9%
Skin And Subcutaneous Tissue Disorders- Other, Rash Unspecified
9%
ORAL PAIN
9%
LYMPHOCYTE COUNT DECREASED
9%
NASAL CONGESTION
9%
WEIGHT GAIN
9%
HYPOCALCEMIA
9%
DRY SKIN
5%
SKIN INFECTION
5%
Skin And Subcutaneous Disorders - Other, Dry Skin Patches
5%
Sore Throat
5%
Skin And Subcutaneous Tissue Disorders - Other, Skin Color Change
5%
Investigations - Other, International Normalized Ration Increased
5%
Musculoskeletal And Connective Tissue Disorder - Other, Tendinitis
5%
Skin And Subcutaneous Tissue Disorders- Other, Blister/Bug Bite On Finger
5%
Skin And Subcutaneous Tissue Disorders- Other, Sore On Lips
5%
Hypertension
5%
SERUM AMYLASE INCREASED
5%
Behaviour Disturbance
5%
Rash Ezcematoid
5%
JOINT RANGE OF MOTION DECREASED
5%
Hypermagnesemia
5%
HYPOMAGNESEMIA
5%
Scalp Pain
5%
Investigations - Other, Eosinophilia
5%
Gastrointestinal Disorders - Other, Dental Pain
5%
Hypotension
5%
Psychiatric Disorders - Other, Mood Swings
5%
URINARY URGENCY
5%
Allergic Rhinitis
5%
Sinus Tachycardia
5%
Periodontal Disease
5%
Peripheral Sensory Neuropathy
5%
Scalp Lesion
5%
Myalgia
5%
Tooth Infection
5%
ANXIETY
5%
Muscle Weakness Lower Limb
5%
Peripheral Motor Neuropathy
5%
Tachycardia
5%
URINARY FREQUENCY
5%
Conjunctivitis
5%
Muscle Weakness Upper Limb
5%
Neuropathy
5%
Sinusitis
5%
Stomach Pain
5%
Syncope
5%
RASH
5%
Activated Partial Thromboplastin Time Prolonged
5%
Gastrointestinal Disorders - Other, Buccal Cyst
5%
HEMATURIA
5%
Breast Pain
5%
Joint Range Of Motion Decreased
5%
INSOMNIA
5%
Surgical & Medical Procedures - Other, Dental Extractions
5%
DIFFICULTY WALKING, BACK PAIN, BOWEL/BLADDER URGENCY, LEGS GAVE OUT, AND PARESTHESIAS
5%
Infections And Infestations - Other, Gi Viral Infection
5%
Skin And Subcutaneous Tissue Disorders- Other, Erythema
5%
TENDONITIS
5%
Infections And Infestations - Other, Covid-19
5%
Investigations - Other, Increased Mean Corpuscular Volume
5%
Skin And Subcutaneous Tissue Disorders- Other, Transient Erythema
5%
SUBJECT WAS ADMITTED TO THE HOSPITAL ON 10/24/20 WITH GRADE 2 WEIGHT LOSS THAT THE PHYSICIAN FELT NE
5%
Injury, Poisoning And Procedural Complications - Other, Ankle Injury
5%
Injury, Poisoning And Procedural Complications- Other, Scalp Laceration
5%
Musculoskeletal And Connective Tissue Disorders - Other, Extremity Cramps
5%
Skin And Subcutaneous Tissue Disorders- Other, New Freckles/Moles
5%
SINUS BRADYCARDIA
5%
HYPERTHYROIDISM
5%
Creatine Phosphokinase Increased
5%
Skin And Subcutaneous Tissue Disorders - Other: Blue Lips (Not Cyanosis)
5%
Urine Discoloration
5%
SPINAL CORD COMPRESSION
5%
ANEMIA
5%
PARONYCHIA
5%
BRUISING
5%
HYPOALBUMINEMIA
5%
Ear And Labyrinth Disorders - Other, Impacted Cerumen
5%
Ear Pain
5%
Elevated Amylase
5%
Facial Pain
5%
Gastrointestinal Disorders - Other, Stomatitis
5%
Hoarseness
5%
Laryngitis
5%
Leg Pain
5%
Localized Edema
5%
Lung Infection
5%
Metabolism And Nutrition Disorders - Other, Decreased Oral Intake
5%
Metabolism Other - Decreased Vitamin D
5%
Metbolism And Nutrition Disorders - Other, Hyperchloremia
5%
Mucositis Oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort B
Cohort A

Trial Design

1Treatment groups
Experimental Treatment
Group I: CabozantinibExperimental Treatment1 Intervention
Cabozantinib, at a dose of 60 mg orally (by mouth), once a day (at bedtime), continuously.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cabozantinib
FDA approved

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver cancer, such as cabozantinib, work by inhibiting receptor tyrosine kinases, which are proteins involved in the signaling pathways that promote tumor growth and angiogenesis (formation of new blood vessels). Cabozantinib specifically targets pathways like c-MET/ERK/p21/PKM2 and VEGFR2, which are essential for cancer cell proliferation and blood supply to tumors. This inhibition can slow down or stop the progression of the cancer. Understanding these mechanisms is crucial for liver cancer patients as it highlights how these treatments can effectively control tumor growth and potentially improve survival outcomes.
Cabozantinib-based combination therapy for the treatment of hepatocellular carcinoma.Targeting molecular signal transduction pathways in hepatocellular carcinoma and its implications for cancer therapy.M2 macrophages mediate sorafenib resistance by secreting HGF in a feed-forward manner in hepatocellular carcinoma.

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,517 Previous Clinical Trials
499,505 Total Patients Enrolled
3 Trials studying Liver Cancer
51 Patients Enrolled for Liver Cancer
IpsenIndustry Sponsor
350 Previous Clinical Trials
74,438 Total Patients Enrolled
Jennifer Knox, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
2 Previous Clinical Trials
57 Total Patients Enrolled

Media Library

Cabozantinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04204850 — Phase 2
Liver Cancer Research Study Groups: Cabozantinib
Liver Cancer Clinical Trial 2023: Cabozantinib Highlights & Side Effects. Trial Name: NCT04204850 — Phase 2
Cabozantinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04204850 — Phase 2
~4 spots leftby Oct 2025