The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2023-12-31

Brief Summary

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To investigate the safety and efficacy of deferoxamine (DFO) combined with conventional transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC).

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Detailed Description

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DFO, an iron chelator, is considered as a potential drug to the treatment of HCC. Ferrum is an important transition metal for organisms and the liver plays a major role in its storage. However, in pathologic conditions, it will lead to hepatocyte injury through the free radicals generated by excess iron. In addition, excess iron accumulation in the liver increases toxic free iron, which is closely associated with hepatic inflammation, as well as the development and progression of HCC. Reduction of iron is likely an important therapeutic targets for treating HCC. Iron reduction therapy has been efficacious in both in animal HCC models and results of clinical studies also suggest potential efficacy for HCC. DFO chelates iron by forming a stable complex that prevents the iron from entering into further chemical reactions. The investigators assume that DFO, combined with TACE, may provide additional efficacy in patients with unresectable HCC.

Conditions

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Hepatocellular Carcinoma Non-resectable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Deferoxamine

Patients are treated with deferoxamine and conventional TACE.

Group Type EXPERIMENTAL

Deferoxamine and conventional TACE

Intervention Type DRUG

Deferoxamine is injected before conventional transarterial chemoembolization.

Conventional TACE

Patients are treated with conventional TACE.

Group Type ACTIVE_COMPARATOR

Conventional TACE

Intervention Type DRUG

Conventional chemoembolization drugs are injected through hepatic artery.

Interventions

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Conventional TACE

Conventional chemoembolization drugs are injected through hepatic artery.

Intervention Type DRUG

Deferoxamine and conventional TACE

Deferoxamine is injected before conventional transarterial chemoembolization.

Intervention Type DRUG

Other Intervention Names

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TACE Deferoxamine & TACE

Eligibility Criteria

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Inclusion Criteria

* Adult patients, ≥ 18 years of age.
* The participant must have histologically-confirmed, unresectable HCC
* At least 1 measurable lesion, and overall tumor lesions occupying \< 50% of liver volume
* The participant has provided signed informed consent
* No known allergy to contrast media
* Not pregnant
* No vascular anatomy or bleeding that would preclude catheter placement or emboli injection

Exclusion Criteria

* Patients receiving concurrent radiotherapy or immunotherapy.
* Patients who have received previous chemotherapy, biological agents, or radiotherapy.
* Prior transarterial chemoembolisation (TACE) or transarterial embolisation (TAE).
* Prior liver transplantation or liver resection.
* Current or recent (within 10 days of study start) use of full-dose anticoagulants for therapeutic purposes.
* Patients with high risk esophageal/gastric varices.
* The participant has central nervous system (CNS) metastases or carcinomatous meningitis
* The participant has poorly-controlled hypertension \[in other words (ie), blood pressure in abnormal range despite medical management\]

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No