The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

Jinan Military General Hospital

Status and phase

Unknown

Phase 1

Conditions

Hepatocellular Carcinoma Non-resectable

Treatments

Drug: Conventional TACE

Drug: Deferoxamine and conventional TACE

Study type

Interventional

Funder types

Other

Identifiers

NCT03652467

JNZY20181245

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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]