JPRN-UMIN000029922尚未招募1 期
Phase 1/2 Study of Hyperthermic Isolated Limb Perfusion with Melphalan for Patients with In-Transit Malignant Melanoma of the Extremity - MM_ILI
Keio Univesity Hospital0 个研究点目标入组 14 人开始时间: 2017年11月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 80years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Have allergic histories of Melphalan or iodine contrast agent. 2) Have a possibility of pregnancy or cannot agree with contraception between the date of informed consent and 3 months after treatment. 3) Have poorly controlled diseases such as heart diseases and pulmonary diseases that can be at risk of general anesthesia and avascularization of limbs. 4) Have in-transit metastases tend to be relieved by pretreatment (if invariant, can be registered even if it is not in exacerbation trend). 5) Be unlikely to survive for 3 months from the original registration due to progress of other organ metastasis. 6) Have a pretreatment history of chemotherapy, immunity checkpoint inhibitor (anti-CTLA-4 antibody) except for anti-PD-1 antibody, interferon alpha-2b, interferon beta, other immunotherapy, and molecular targeted therapeutic agents within 4 weeks from the date of registration. 7) Within 8 weeks after initiation of anti-PD-1 antibody, or after 8 weeks and effective for treatment. 8) Have a limb ischemic disease (such as obstructive arteriosclerosis and Buerger's disease), severe vasculitis. Doctors judge (In principle ABI 0.9 or above is the qualification criteria, and if less than 0.9, assess the suitability by MR angiography/ CT angiography.) 9) Have a symptomatic brain metastasis. 10) Be determined to be ineligible by doctors.
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