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A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)

Last updated on March 14, 2019

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Study Location
Aichi Cancer Center Hospital
Nagoya, Aichi, 464-8681 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatocellular Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Diagnosis of locally advanced or metastatic HCC, obtained by histology/cytology (on a
prior tumor biopsy) or by imaging with serum α-fetoprotein (AFP) ≥400 ng/mL.

- All patients must provide at least 1 archival tumor specimen. If archival tumor
specimen is no longer available, de novo tumor biopsy will be required during
screening.

- HCC not amenable to local therapy.

- Measurable disease according to RECIST v. 1.1.

- Child Pugh Class A disease.

- BCLC stage B or C disease.

- No evidence of uncontrolled hypertension as documented by 2 baseline blood pressure
readings taken at least 1 hour apart.

- ECOG performance status 0 or 1.

- Adequate bone marrow function, renal and liver functions

- Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (LLN) as assessed by
multigated acquisition (MUGA) scan or echocardiogram (ECHO).

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Prior systemic treatment for advanced HCC, including prior treatment with approved or
investigational drugs.

- Any prior locoregional therapy within 4 weeks and radiotherapy or surgical procedure
within 2 weeks (4 weeks for major surgery) of enrollment.

- Patients with known symptomatic brain metastases requiring steroids.

- Presence of hepatic encephalopathy (ie, Child Pugh score of 2 or 3) and/or clinically
relevant ascites (ie, Child Pugh score of 3).

- Presence of main portal vein invasion by HCC.

- Any of the following within the 12 months prior to enrollment: myocardial infarction,
severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic
congestive heart failure, LVEF less than LLN, clinically significant pericardial
effusion, cerebrovascular accident, transient ischemic attack.

- Active infection requiring systemic therapy except for hepatitis C virus (HCV) and
hepatitis B virus (HBV).

NCT03289533
Pfizer
Active, not recruiting
A Study Of Avelumab In Combination With Axitinib In Advanced HCC (VEGF Liver 100)

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[email protected]

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