- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652467
The Safety and Efficacy of Deferoxamine for Treating Unresectable Hepatocellular Carcinoma
February 20, 2019 updated by: Li Min, Jinan Military General Hospital
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shandong
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Jinan, Shandong, China, 250031
- Recruiting
- 960th hospital of PLA
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Contact:
- Min Li, M.D.
- Phone Number: 13953176057
- Email: liminyingxiang@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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]
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Deferoxamine
Patients are treated with deferoxamine and conventional TACE.
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Deferoxamine is injected before conventional transarterial chemoembolization.
Other Names:
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Active Comparator: Conventional TACE
Patients are treated with conventional TACE.
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Conventional chemoembolization drugs are injected through hepatic artery.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer
Time Frame: First dose to date of progressive disease or death due to any cause [every 3 cycles up to 36 months (1 cycle=2 weeks)]
|
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.
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First dose to date of progressive disease or death due to any cause [every 3 cycles up to 36 months (1 cycle=2 weeks)]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Progression
Time Frame: First dose to date of PD [every 3 cycles up to 36 months (1 cycle=2 weeks)]
|
The time from first day of therapy to the first date of objective evidence of progressive disease (PD) by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
PD is defined as having at least a 20% increase in sum of longest diameter of target lesions and/or unequivocal progression of a non-target lesion and/or detection of new lesion.
Time to PD is censored at the date of death or study discontinuation.
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First dose to date of PD [every 3 cycles up to 36 months (1 cycle=2 weeks)]
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Overall Survival
Time Frame: First dose to date of death up to 36 months
|
Overall survival (OS) is the duration from first dose to death due to any cause.
OS is censored at last contact date for participants who are alive at the end of follow-up period or lost to follow-up.
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First dose to date of death up to 36 months
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Percentage of Participants With Complete Response or Partial Response
Time Frame: First dose to date of objective progressive disease (PD) or death up to 36 months
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Objective response rate (ORR) is defined as the percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR).
As classified according to Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR is the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeters (mm) and normalization of tumor marker level of non-target lesions.
PR is having at least a 30% decrease in sum of longest diameter of target lesions.
|
First dose to date of objective progressive disease (PD) or death up to 36 months
|
Duration of Response
Time Frame: 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)]
|
Duration of response is the interval from the date of initial documented response [complete response (CR) , partial response (PR) or Stable disease] to the first documented date of disease progression, initiation of other (or additional) antitumor therapy is first reported, or death due to any cause.
As classified according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, CR is the disappearance of all target lesions, PR is having at least a 30% decrease in the sum of the longest diameter of target lesions, and stable disease is defined as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
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.
Data are censored for participants who did not progress or die.
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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)]
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Tumor Necrosis
Time Frame: Baseline to the end of the study (up to 3 years, 36 months)
|
Tumor necrosis is quantified in liver lesions greater than 2 cm at Baseline.
When MRI showed many cut surfaces for a single tumor, tumor size and the size of necrotic area is measured by accumulation of the serial sections containing the tumor.
Lipiodol accumulation without contrast enhance in tumor after TACE is regarded as an indication of necrosis.
Tumor necrosis is assessed at Baseline and 1-3 days prior to the next scheduled transarterial chemoembolisation (TACE) till disease progression.
The extent of tumor necrosis is presented as the percentage of the tumor volume at Baseline.
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Baseline to the end of the study (up to 3 years, 36 months)
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Number of Participants With Iron Reduction of Liver
Time Frame: Baseline to the end of the study (up to 3 years, 36 months)
|
The iron of liver will be measured by MRI, where R2* and QSM is applied to present the quantity of iron.
Iron reduction is assessed at Baseline and 1-3 days prior to the next scheduled transarterial chemoembolisation.
The test will be repeated 1 -3 days after the therapy.
The reduction of liver iron will be calculated accordingly.
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Baseline to the end of the study (up to 3 years, 36 months)
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The Prognostic Value of Reduction of Liver Iron
Time Frame: Prior to TACE at baseline, 1 -3 days after the therapy
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The iron of liver will be measured by MRI, where R2* and QSM is applied to present the quantity of iron.
All patients will undergo MRI before TACE, and the test will be repeated 1 -3 days after the therapy till disease progression.
The reduction of liver iron will be calculated accordingly.
Based on the measurements mentioned above, the prognostic value of reduction of liver iron will be analyzed.
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Prior to TACE at baseline, 1 -3 days after the therapy
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Number of Participants With Drug-Related Treatment-Emergent Adverse Events
Time Frame: First dose to 36 months
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Data presented are the number of participants who experienced treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 or higher TEAEs, or adverse events (AEs) leading to discontinuation of treatment that are considered by the investigator to be related to ramucirumab.
A summary of SAEs and other nonserious AEs, regardless of causality, is located in the Reported Adverse Events section.
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First dose to 36 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Anticipated)
September 1, 2022
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
August 22, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
February 22, 2019
Last Update Submitted That Met QC Criteria
February 20, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Estrogens, Non-Steroidal
- Estrogens
- Chelating Agents
- Sequestering Agents
- Iron Chelating Agents
- Siderophores
- Chlorotrianisene
- Deferoxamine
Other Study ID Numbers
- JNZY20181245
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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