Hepatocellular Carcinoma


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 (HCC) 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

  • 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.

Main inclusion criteria

  • Locally advanced or metastatic HCC
  • Failure of one prior antiangiogenic therapy. Antiangiogenic agents include sorafenib, bevacizumab, and brivanib only.
  • Child-Pugh Class A
  • ECOG performance status 0 or 1
  • Contact study team for remaining details

Main exclusion criteria

  • Contact study team for details. 

Costs for the patient

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

Principal investigator

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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 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

  • Locally advanced or metastatic HCC
  • Must have failed sorafenib. Sorafenib must have been the most recent treatment.
  • Child-Pugh score of < 9
  • ECOG performance status 0 or 1.
  • Contact study team for remaining details

Main exclusion criteria

  • Contact study team for details.

Costs for the patient

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

Principal investigator

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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.

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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

  • 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:

    • Histology

    • 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

Main exclusion criteria

  • Clinical evidence of significant hepatic decompensation

    • Refractory ascites

    • Grade 3–4 encephalopathy

    • Hepatorenal syndrome

    • 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

Principal investigator

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