The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    100
  • sponsor
    Jinan Military General Hospital
Updated on 22 January 2021

Summary

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

Description

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.

Details
Condition Hepatocellular Carcinoma Non-resectable
Treatment Conventional TACE, Deferoxamine and conventional TACE
Clinical Study IdentifierNCT03652467
SponsorJinan Military General Hospital
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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]
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