Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib

May 1, 2026 updated by: Memorial Sloan Kettering Cancer Center

Phase II Study of Sorafenib Plus Doxorubicin in Patients With Advanced Hepatocellular Carcinoma With Disease Progression on Sorafenib

The purpose of this study is to find out what effects, good and/or bad, the combination of the drug sorafenib in combination with the drug doxorubicin might have on the growth and spread of liver cancer (HCC).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States
        • Memorial Sloan Kettering Cancer Center at Basking Ridge
    • New York
      • Commack, New York, United States, 11725
        • Memorial Sloan Kettering Cancer Center @ Suffolk
      • Harrison, New York, United States, 10604
        • Memorial Sloan Kettering West Harrison
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • Rockville Centre, New York, United States, 11570
        • Memorial Sloan Kettering Cancer Center at Mercy Medical Center
      • Sleepy Hollow, New York, United States, 10591
        • Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of HCC confirmed histologically, excluding mixed HCC histology (e.g. HCC plus cholangiocarcinoma) or fibrolamellar variant.
  • Prior treatment with sorafenib as single agent or in combination, with no less than 200 mg once every other day dose of sorafenib, with radiologic evidence of progression of disease.
  • Measurable disease using RECIST 1.1 criteria.
  • Non-cirrhotic or no more than Child-Pugh A cirrhosis.
  • Expected survival of at least 3 months.
  • Age ≥ 18 years.
  • KPS ≥ 70%
  • Fully recovered from any prior surgery and/or radiation and none within 2 weeks of initiating treatment.
  • Patients may have been treated with locoregional liver directed therapies such as embolization, chemo-embolization including drug-eluting beads doxorubicin chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is excluded), radiation, radioactive microspheres, etc., provided that they either have a target lesion that has not been subjected to local therapy and/or the target lesion(s) within the field of the local therapy has shown an increase of ≥25% in the size since last treatment. Such therapy must be completed at least 4 weeks prior to treatment initiation. Patients that have received palliative radiation therapy to the bone need not wait 4 weeks to begin protocol therapy.
  • Informed consent must be obtained prior to study initiation.
  • Total bilirubin ≤3.0 mg/dL and no evidence of bile obstruction.
  • Absolute neutrophil count (ANC) ≥1,500/μL.
  • Platelets ≥75,000/μL.
  • Serum creatinine ≤ 1.5 x the upper limit of normal range, or, if serum creatinine >1.5 x the upper limit of normal range, then the creatinine clearance must be ≥ 60 mL/min.
  • Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon.
  • Patients with a history of hypertension should be well controlled (< 140/90 mmHg) on a regimen of anti-hypertensive therapy.
  • Brain metastases are allowed if well controlled and without seizures.
  • Prior palliative radiation therapy to bone sites is allowed as long as it is completed more than two weeks ago.

Exclusion Criteria:

  • Significant cardiac disease:
  • Congestive heart failure > Class II New York Heart Association (NYHA).
  • Myocardial infarction within 6 months prior to study entry.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  • Serious myocardial dysfunction, defined as scintigraphically (MUGA, myocardial scintigram) or echocardiogram determined absolute left ventricular ejection fraction (LVEF) below normal (<50%).
  • Participation in concurrent investigational studies.
  • Prior loco-regional therapy including drug-eluting beads doxorubicin chemoembolization (prior non drug eluting beads chemoembolization with doxorubicin is excluded) is allowed.
  • Prior exposure to systemic intravenously given doxorubicin.
  • Pregnancy or lactation.
  • Uncontrolled inter-current illness or psychiatric illness or social situations that would limit compliance with study requirements.
  • Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis. Allografts, including but not limited to liver and bone marrow transplants.
  • Bleeding esophageal or gastric varices within 30 days prior to treatment initiation.

Concomitant treatment with Rifampin or St John's Wort. Patients should discontinue these drugs at least 4 weeks prior to starting protocol treatment.

  • Subjects known to be HIV positive.
  • History of bleeding diathesis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sorafenib plus Doxorubicin
Doxorubicin 60 mg/m2 IV on Day 1 of each 3 weeks cycle until unacceptable toxicity Sorafenib 400 mg PO BID or last dose patient from previous sorafenib based therapy, until unacceptable toxicity or disease progression, after which sorafenib can be continued as a single agent.
Drug: Doxorubicin
Drug: Sorafenib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
median overall survival
Time Frame: 2 years
2 years
median time to progression
Time Frame: 2 years
2 years
median progression free survival
Time Frame: 2 years
2 years
toxicity
Time Frame: 2 years
Toxicity rate will be reported by type and severity according to the NCI common toxicity criteria version 4 and descriptive statistics will be provided.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Bayer
National Comprehensive Cancer Network

Investigators

  • Principal Investigator: Ghassan Abou-Alfa, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimated)

April 25, 2013

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 1, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-259

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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