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Anti-tumor antibiotic

Sorafenib + Doxorubicin for Liver Cancer

Phase 2
Waitlist Available
Led By Ghassan Abou-Alfa, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-cirrhotic or no more than Child-Pugh A cirrhosis
Age ≥ 18 years
Must not have
History of bleeding diathesis
Significant cardiac disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will test the effect of combining two drugs, sorafenib and doxorubicin, on liver cancer growth and spread.

Who is the study for?
This trial is for adults with advanced liver cancer (HCC) who have seen their disease progress despite being treated with Sorafenib. They should not have severe cirrhosis, heart issues, or other serious illnesses and must not be pregnant. Prior treatments are allowed under certain conditions, but they can't have had systemic doxorubicin before.
What is being tested?
The study tests the combination of two drugs: Sorafenib and Doxorubicin on liver cancer growth after previous treatment failure with just Sorafenib. It aims to understand the effects—both good and bad—of this drug duo on controlling cancer progression.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, vomiting, hair loss, mouth sores; heart problems due to Doxorubicin; increased blood pressure from Sorafenib; and possible liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver is healthy or only slightly damaged.
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I am 18 years old or older.
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I am mostly able to care for myself.
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My liver cancer is confirmed and not a mixed or fibrolamellar type.
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I've been treated with sorafenib for my cancer, but it has still progressed.
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My bilirubin levels are low and I don't have a bile duct blockage.
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My kidney function is within the normal range.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of unusual bleeding.
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I have a serious heart condition.
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I have been treated with doxorubicin through an IV before.
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I have had an organ or bone marrow transplant from a donor.
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I am not taking Rifampin or St John's Wort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
toxicity

Side effects data

From 2020 Phase 2 trial • 40 Patients • NCT01900002
12%
AST increase
12%
Hypertension
9%
Hyponatremia
9%
Fatigue
6%
Vomiting
6%
Nausea
6%
Dizziness
6%
Diarrhea
6%
ALT increase
3%
Weight Loss
3%
Hypertenstion
3%
Duodenal Ulcer
3%
Sepsis
3%
Acute Renal Failure
3%
Hypotension
3%
Hypophosphatemia
3%
Hematuria
3%
Hepatic Hemorrhage
3%
Urinary Retention
3%
Dyspnea
3%
Weakness
3%
Abdominal Pain
3%
Rectal Bleed
3%
Palmar-Planta Erythrodysesthesia
3%
Thrombocytopenia
3%
Hyperbilirubinemia
3%
Proteinuria
3%
Mucositis
3%
Encephalopathy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Sorafenib Tosylate, TheraSphere)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Sorafenib plus DoxorubicinExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~8030
Sorafenib
2014
Completed Phase 3
~1670

Find a Location

Who is running the clinical trial?

BayerIndustry Sponsor
2,260 Previous Clinical Trials
25,309,415 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,526 Total Patients Enrolled
21 Trials studying Liver Cancer
7,813 Patients Enrolled for Liver Cancer
National Comprehensive Cancer NetworkNETWORK
118 Previous Clinical Trials
7,860 Total Patients Enrolled
2 Trials studying Liver Cancer
64 Patients Enrolled for Liver Cancer

Media Library

Doxorubicin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01840592 — Phase 2
Liver Cancer Research Study Groups: Sorafenib plus Doxorubicin
Liver Cancer Clinical Trial 2023: Doxorubicin Highlights & Side Effects. Trial Name: NCT01840592 — Phase 2
Doxorubicin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01840592 — Phase 2
~1 spots leftby Apr 2025
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