Clinical trial NCT03652467: The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma
Official title: The Safety and Efficacy of Deferoxamine Combined With Conventional Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hepatocellular Carcinoma Non-resectable
Keywords: Deferoxamine
Transarterial chemoembolization
Unresectable hepatocellular carcinoma
Lead sponsor: Jinan Military General Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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 \[in other words (ie), blood pressure in abnormal range despite medical management\]

Primary outcomes:
measure: Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer
timeFrame: First dose to date of progressive disease or death due to any cause [every 3 cycles up to 36 months (1 cycle=2 weeks)]
Secondary outcomes:
measure: Time to Progression
timeFrame: First dose to date of PD [every 3 cycles up to 36 months (1 cycle=2 weeks)]
measure: Overall Survival
timeFrame: First dose to date of death up to 36 months
measure: Percentage of Participants With Complete Response or Partial Response
timeFrame: First dose to date of objective progressive disease (PD) or death up to 36 months
measure: Duration of Response
timeFrame: Time of first response (CR, PR or Stable disease) to disease progression, or death due to any cause [every 3 cycles up to 36 months (1 cycle=2 weeks)]
measure: Tumor Necrosis
timeFrame: Baseline to the end of the study (up to 3 years, 36 months)
measure: Number of Participants With Iron Reduction of Liver
timeFrame: Baseline to the end of the study (up to 3 years, 36 months)
measure: The Prognostic Value of Reduction of Liver Iron
timeFrame: Prior to TACE at baseline, 1 -3 days after the therapy
measure: Number of Participants With Drug-Related Treatment-Emergent Adverse Events
timeFrame: First dose to 36 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: 960th hospital of PLA
state: Shandong
Study officials:
References: