JPRN-jRCT2041230050招募中4 期
An Uncontrolled, Open-label, Multicenter Safety Confirmation Study of 5 or More Cycles of Photoimmunotherapy with Cetuximab Sarotalocan Sodium (Genetical Recombination) in Patients with Unresectable, Locally Advanced or Locally Recurrent Head and Neck Cancer
agamatsu Kazuo0 个研究点目标入组 35 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Patients with unresectable, locally advanced, or locally recurrent head and neck cancer
- •2. Patients who failed to respond to standard therapies such as chemoradiotherapy or for whom no appropriate therapy is available
- •3. Patients who had completed the fourth cycle of photoimmunotherapy with Akalux after its market launch and require the fifth cycle
- •4. Patients with at least one lesion of head and neck cancer that can be illuminated
- •5. Patients aged 18 years or older at the time of enrollment
- •6. Patients
排除标准
- •1. Patients with Grade 3 or higher AEs that fail to recover to Grade 2 or lower after the fourth cycle of Akalux photoimmunotherapy (PIT) If the principal investigator (sub-investigator) of the post-marketing clinical study judges that the toxicity is acceptable, the appropriateness of enrollment may be judged after discussion with the medical monitor at the sponsor of the post-marketing clinical study.
- •2. Patients with ECOG PS >=3
- •3. Patients who received other treatments for the underlying disease after the fourth cycle of Akalux PIT
- •4. Patients with unequivocal disease progression after the fourth cycle of Akalux PIT
- •5. Patients whose lesions after the fourth cycle of Akalux PIT are CR and who need PIT for lesions other than those at the laser illuminated site
- •6. Patients with a history of hypersensitivity to any of the ingredients of ASP-1929
- •7. Patients with tumor involvement of the carotid artery
- •8. Female patients with positive pregnancy tests
- •Female patients require pregnancy testing if they have had their first menstrual period, had not undergone a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, and have not had their periods for at least 12 months without an alternative medical cause.
- •9. Nursing mothers and females who may (or intend to) become pregnant during the study period
- •10. Males unwilling to use contraception
- •11. Any condition which in the investigator opinion deems the patient an unsuitable candidate to receive study treatment
研究者
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