The Safety and Efficacy of Deferoxamine Combined With Conventional Transarterial Chemoembolization in Patients With Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer
研究概览
简要总结
To investigate the safety and efficacy of deferoxamine (DFO) combined with conventional transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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]
研究组 & 干预措施
Deferoxamine
Patients are treated with deferoxamine and conventional TACE.
干预措施: Deferoxamine and conventional TACE (Drug)
Conventional TACE
Patients are treated with conventional TACE.
干预措施: Conventional TACE (Drug)
结局指标
主要结局
Progression Free Survival (PFS) in Participants With Unresectable Hepatocellular Cancer
时间窗: 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.
次要结局
- Overall Survival(First dose to date of death up to 36 months)
- Time to Progression(First dose to date of PD [every 3 cycles up to 36 months (1 cycle=2 weeks)])
- 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))
- Number of Participants With Iron Reduction of Liver(Baseline to the end of the study (up to 3 years, 36 months))
- The Prognostic Value of Reduction of Liver Iron(Prior to TACE at baseline, 1 -3 days after the therapy)
- Number of Participants With Drug-Related Treatment-Emergent Adverse Events(First dose to 36 months)
研究者
Li Min
Director
Jinan Military General Hospital