The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma

NCT03652467 | Unknown Phase 1

• 1 other identifier: JNZY20181245
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatocellular Carcinoma Non-resectable

Keywords

Deferoxamine; Transarterial chemoembolization; Unresectable hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer

  PFS is defined as the time from the first day of therapy to the first evidence of disease progression or death from any cause. As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, disease progression is having at least a 20% increase in the sum of the longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of a new lesion. Participants who are alive and without disease progression and participants who did not progress and are subsequently lost to follow-up are censored at the last objective tumor assessment.

  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 (8)

• Time to Progression

  First dose to date of PD [every 3 cycles up to 36 months (1 cycle=2 weeks)]

• Overall Survival

  First dose to date of death up to 36 months

• Percentage of Participants With Complete Response or Partial Response

  First dose to date of objective progressive disease (PD) or death up to 36 months

• Duration of Response

  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)]

• Tumor Necrosis

  Baseline to the end of the study (up to 3 years, 36 months)

Study Arms (2)

Deferoxamine

EXPERIMENTAL

Patients are treated with deferoxamine and conventional TACE.

Drug: Deferoxamine and conventional TACE

Conventional TACE

ACTIVE COMPARATOR

Patients are treated with conventional TACE.

Drug: Conventional TACE

Interventions

Conventional TACE DRUG

Conventional chemoembolization drugs are injected through hepatic artery.

Also known as: TACE

Conventional TACE

Deferoxamine and conventional TACE DRUG

Deferoxamine is injected before conventional transarterial chemoembolization.

Also known as: Deferoxamine & TACE

Deferoxamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jinan Military General Hospital: lead

Study Sites (1)

960th hospital of PLA

Jinan, Shandong, 250031, China

RECRUITING

MeSH Terms

Interventions

Deferoxamine

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: August 29, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: December 31, 2023
• Last Updated: February 22, 2019

Record last verified: 2019-02

Locations

CN (1)