To compare the overall survival of patients with advanced HCC receiving axitinib + best supportive care (BSC) versus (vs) placebo + BSC following failure of one prior antiangiogenic therapy.
Patients will be randomized (2:1 ratio) to receive either axitinib + BSC (Arm A) or placebo + BSC (Arm B).
Axitinib or placebo will be administered, twice daily (BID) on a continuous daily dosing schedule.
The primary objective is to compare the overall survival (OS; time from randomization to death) in patients with hepatocellular carcinoma (HCC) who had disease progression during or following sorafenib therapy, or were intolerant to this agent. Patients will receive either ramucirumab (IMC-1121B) drug product plus best supportive care (BSC) or placebo plus BSC.
1:1 randomization of IV ramucirumab/placebo infusion every 2 weeks. A treatment cycle will be defined as 2 weeks, with radiologic evaluation every 6 weeks (± 3 days) after first dose of study therapy for the first 6 months, and every 9 weeks (± 3 days) thereafter.
To evaluate current staging system for patients with hepatocellular carcinoma (HCC) and evaluate if new blood tests at the time of HCC diagnosis improves the accuracy of predicting outcomes of patients with liver cancer.
To evaluate the usefulness of new markers found in blood that may help to diagnose hepatocellular carcinoma (HCC) early among people with cirrhosis. If we can establish new tumor markers for the detection of this tumor at early stage, which are currently lacking, this information could be applied to patients at the highest risk of HCC. We plan to store blood for this and future studies that may lead to better tests for the early detection of HCC.
Able and willing to provide written informed consent
Age ≥18 years of age
AFP lab result within 180 days prior to date of consent
All other lab results within 180 days prior to date of consent
Ultrasound or other imaging within 6 months prior to consent OR up to 2 weeks after consent showing no liver mass
Diagnosis of cirrhosis based one or more of the following:
US or CT showing cirrhotic appearing liver with splenomegaly and platelet count
of < 120 mm³
Esophageal or gastric varicies on endoscopy AND presence of chronic liver disease
MELD ≤ 15 OR INR is ≤ 1.5, total bilirubin is ≤ 1.7 and patient has a history of intrinsic renal disease
Clinical evidence of significant hepatic decompensation
Grade 3–4 encephalopathy
Child Class C
AFP ≥ 20 ng/ml without proof of a dynamic CT scan or triple phase MRI within 3 months prior to consent OR up to 2 weeks after consent indicating no mass suggestive of HCC
Detection of HCC at initial evaluation
Significant co-morbid medical conditions with life expectancy less than 1 year
Cancer history within the last 5 years (excluding non-melanoma skin cancer)
Need for long-term immunosuppressive therapy for solid organ transplant
Prior solid organ transplant
Michael Volk, MD email@example.com