Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma (NCT04472767) | Clinical Trial Compass
RecruitingPhase 2
Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma
United States35 participantsStarted 2020-08-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. Leukocytes β₯ 2,000/mcL
β. absolute neutrophil count β₯ 1000/mcL
β. platelets β₯ 60,000/mcl
β. total bilirubin within normal institutional limits
β. AST(SGOT)/ALT(SPGT) β€ 3 X institutional upper limit of normal or β€ 5 X if liver metastases are present
β. creatinine \<1.5ULN
β. hemoglobin β₯ 8 g/dL
β. Serum albumin β₯ 2.8 g/dL
Exclusion criteria
β. Prophylactic use of low-dose aspirin for cardioprotection (per local applicable guidelines) and low dose low molecular weight heparins (LMWH).
β. Therapeutic doses of LMWH in subjects with a screening platelet count \> 100,000/ΞΌL, without known brain metastases, and who are on a stable dose of the anticoagulant for at least 1 week before first dose of study treatment without clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
β. ongoing or active infection
β. symptomatic congestive heart failure
β. uncontrolled hypertension defined as sustained blood pressure (BP) \> 150 mm Hg systolic or \> 100 mm Hg diastolic despite optimal antihypertensive treatment
What they're measuring
1
Percentage of Participants with Progression-free Survival at 6 Months
Timeframe: 6 months
2
Complete Response Rate
Timeframe: From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
Trial details
NCT IDNCT04472767
SponsorUniversity of California, Irvine
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2026-06-01
Contact for this trial
Chao Family Comprehensive Cancer Center University of California, Irvine
β. Stroke (including transient ischemic attack \[TIA\]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose