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New combo tackles liver cancer after standard drug fails

NCT ID NCT01840592

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

30 people

The number who actually took part.

Started

Apr 2013

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Cancer Center at Basking Ridge

    Basking Ridge, New Jersey, United States

  • Memorial Sloan Kettering Cancer Center at Mercy Medical Center

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center

    Sleepy Hollow, New York, 10591, United States

  • Memorial Sloan Kettering West Harrison

    Harrison, New York, 10604, United States

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