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Hepatocellular Carcinoma

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A multicenter, global, randomized, double-blind study of axitinib plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma following failure of one prior antiangiogenic therapy

 

Enrollment status: Closed for enrollment; patients continue to be followed.

 

Primary objective

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.

Study design

Main inclusion criteria

Main exclusion criteria

Costs for the patient

Principal investigator: Michael Volk, MDmvolk@med.umich.edu

Contact persons:

Sherry Fu – (734) 647-3635 or sherryfu@med.umich.edu

Natalie Fisher – (734) 232-0284 or brownnat@med.unich.edu


A multicenter, randomized, double-blind, phase 3 study of ramucirumab (IMC-1121B) drug product and best supportive care (BSC) versus placebo and BSC as second-line treatment in patients with hepatocellular carcinoma following first-line therapy with sorafenib

 

Enrollment status: Closed for enrollment; patients continue to be followed.

 

Primary objective

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 (hereafter referred to as ramucirumab DP) plus best supportive care (BSC) or placebo plus BSC.

Study design

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.

Main Inclusion Criteria

Main exclusion criteria

Costs for the patient

Most study-related testing costs covered by the sponsor; study medication provided free of charge.

Principal investigator: Michael Volk, MDmvolk@med.umich.edu

Contact persons:

Sherry Fu – (734) 647-3635 or sherryfu@med.umich.edu

Natalie Fisher – (734) 232-0284 or brownnat@med.unich.edu


Diagnosis and prognosis of patients with hepatocellular carcinoma

 

Enrollment status: Actively enrolling

 

Primary objective

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.

Principal investigator: Michael Volk, MD mvolk@med.umich.edu

Contact persons:

Sherry Fu (734) 647-3635 or sherryfu@umich.edu

Natalie Fisher (734) 232-0284 or brownnat@umich.edu


Early detection and prognosis of hepatocellular carcinoma

Enrollment status: Actively enrolling

Primary objective

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.

Main inclusion criteria

Main exclusion criteria

Principal investigator

Contact persons