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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

Hyponatremia

Fatigue

ALT increase

Vomiting

Nausea

Dizziness

Diarrhea

Hypophosphatemia

Mucositis

Encephalopathy

Weight Loss

Hypertenstion

Duodenal Ulcer

Sepsis

Acute Renal Failure

Hypotension

Hematuria

Hepatic Hemorrhage

Urinary Retention

Dyspnea

Weakness

Abdominal Pain

Rectal Bleed

Palmar-Planta Erythrodysesthesia

Thrombocytopenia

Hyperbilirubinemia

Proteinuria

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (Sorafenib Tosylate, TheraSphere)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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