The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

The Safety and Efficacy of Deferoxamine Combined With Conventional Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma

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

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.

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]