Actively Recruiting
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Led by University of California, Irvine · Updated on 2026-04-30
35
Participants Needed
1
Research Sites
368 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2 single-arm, open-label clinical trial determining efficacy of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.
CONDITIONS
Official Title
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic or radiographic diagnosis of hepatocellular carcinoma
- At least one lesion amenable to TACE treatment
- Child-Pugh A-B7 (B7 based on Albumin allowed)
- Not a candidate for resection or transplantation
- Age 18 years or older
- ECOG performance status 0, 1, or 2
- At least one measurable lesion (untreated or progressed after previous locoregional treatment)
- Adequate organ and marrow function as specified
- Women of child-bearing potential and men must agree to use effective contraception
- Female of child-bearing potential defined by specific criteria
- Life expectancy greater than 3 months
- Ability to swallow tablets
- Willingness to sign informed consent
You will not qualify if you...
- Any prior systemic anti-cancer treatment
- Toxicities from prior anti-cancer therapy other than alopecia not resolved to grade 1 or baseline
- Locoregional treatment for HCC within 3 months
- Vp4 or Vp3 portal vein thrombus
- Extrahepatic disease
- Use of other investigational agents
- Allergic reactions to study drugs or similar compounds
- Concomitant use of certain anticoagulants (exceptions apply)
- Prothrombin time (PT)/INR or PTT test ≥ 1.3 x ULN within 28 days before first dose
- Uncontrolled illnesses such as active infections, heart failure, uncontrolled hypertension, recent stroke or ischemic events, unstable angina, arrhythmia
- Gastrointestinal conditions like tumor invading GI tract, active ulcers, inflammatory bowel disease, recent abdominal fistula, perforation, obstruction, or abscess
- Significant bleeding events within 12 weeks before first dose
- Cavitating pulmonary lesions or airway disease
- Lesions invading major blood vessels except intrahepatic vasculature
- Other disorders precluding safe participation such as serious wounds, uncontrolled hypothyroidism, moderate to severe hepatic impairment
- Psychiatric or social conditions limiting compliance
- Major surgery within 2 weeks or minor surgery within 10 days before first dose without complete healing
- Prior treatment with cabozantinib
- QTcF > 500 ms within 28 days before first dose
- Use of small molecule kinase inhibitors within 2 weeks before first dose
- History of other primary cancers within 3 years except certain treated cancers
- Inability to comply with study procedures
- Pregnancy or nursing
- Fibrolamellar HCC
- Recent systemic anticancer therapy or radiation therapy within specified timeframes
- Live vaccine within 30 days before first dose
- Immunodeficiency or recent immunosuppressive therapy
- Severe hypersensitivity to study drugs
- Active autoimmune disease requiring recent systemic treatment
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known HIV infection
- Known active tuberculosis
- Conditions or therapies that may interfere with study or participant safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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