New combo tackles liver cancer after standard drug fails
NCT ID NCT01840592
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding doxorubicin to sorafenib can help people with advanced liver cancer whose disease has progressed while on sorafenib alone. The study enrolls 30 adults with confirmed liver cancer and Child-Pugh A cirrhosis or no cirrhosis. Researchers are measuring overall survival, tumor progression, and side effects to see if the combination is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sorafenib and doxorubicin
- What this could lead to
- If it works, this combination could offer a new treatment option for people with advanced liver cancer whose disease has worsened on standard sorafenib therapy.
- What could go wrong
- This is a small, early-phase trial with only 30 participants, so results may not apply widely. The combination may cause significant side effects, and there is no guarantee it will improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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30 people
The number who actually took part.
- Started
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Apr 2013
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
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Memorial Sloan Kettering Cancer Center at Basking Ridge
Basking Ridge, New Jersey, United States
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Memorial Sloan Kettering Cancer Center at Mercy Medical Center
Rockville Centre, New York, 11570, United States
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Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center
Sleepy Hollow, New York, 10591, United States
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Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
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