JPRN-jRCT2031230036招募中Unknown
Anti-PD-1 antibody therapy for epithelial skin malignancies: an investigator-initiated, open-label, single-arm, multicenter, expanded access program.
Takeru Funakoshi0 个研究点目标入组 27 人开始时间: 2023年4月17日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 27
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Age 20 years or older
- •2) Patients who are incurable by surgical treatment and radiation treatment, and who have been confirmed by histology to have advanced or recurrent epithelial skin malignancies
- •3) Patients who have more than one of measurable lesions or immeasurable lesion as defined in RECIST Guideline Version 1.1 within 14 days prior to enrollment in this clinical trial
- •4) Patients with ECOG PS 0-1
排除标准
- •1) Patients who have high degree of hypersensitivity or medical history of the other antibody product
- •2) Patients who judged by principal investigator or sub-investigator to influence the drug safety evaluation, because of who have been remained side effects of previous treatment or the impact of the surgery
- •3) Patients who have been merged the autoimmune disease or who have medical history of the autoimmune disease (chronic or recurrent)
- •4) Patients who have cancer duplication (However, patients who have been completely resected carcinoma (basal cell, epithelial, mucosal or superficial bladder) or patients who have other carcinoma that don't show recurrence more than five years before obtaining consent are can be registered)
- •5) Patients who have central nervous system metastasis (However, patients who are asymptomatic and do not need treatment can be registered)
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