JPRN-jRCT2080224666暂停1 期
A phase Ib/II clinical study to investigate safety and efficacy of photo-immunotherapy (PIT) using ASP-1929 in patients with esophageal cancer for which complete cure cannot be expected with existing therapies
ational Cancer Center Hospital East0 个研究点目标入组 43 人开始时间: 2019年5月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 43
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
- •Inclusion criteria including below but not limited to:
- •1) Esophageal cancer patients histologically diagnosed with squamous cell carcinoma.
- •2) Patients in whom the wall invasion depth of esophageal cancer is judged as less than T2 by endoscopy and endoscopic ultrasonography. (in case of patients of Target 1, at the remaining or recurrent lesion).
- •3) The following patients of Target 1 or Target 2.
- •Target 1:Among esophageal cancer patients with a local remaining or recurrent lesion after chemotherapy(CRT) or radiotherapy(RT), those who meet either of the following conditions:
- •Patients who show a local lesion remaining or recurrent after Laserphyrin photodynamic therap(PDT).
- •Patients who are not targeted in Laserphyrin PDT.
- •Target 2:Esophageal cancer patients intolerant to surgical resection as well as RT, or not wishing either treatment.
- •4) Patients showing neither lymph node metastasis nor distant metastasis in image by CT at screening.
- •5) Patients aged greater than 20 years at the time of consent obtaining.
- •6) Patients whose ECOG performance status (PS) is in the range of 0 to 2 within 14 days before enrollment.
- •7) Patients from whom written consent to participate in the study is obtained.
- •8) Patients who are judged to have sufficient organ functions based on laboratory values measured within 14 days before enrollment.
- •9) Female patients of childbearing potential.
排除标准
- •Exclusion criteria including below but not limited to:
- •1) In case of Target 1, patients in whom aorta invasion of the primary lesion is judged in the CT performed before chemoradiotherapy or radiotherapy
- •2) Patients in whom the lesion exceeds the size or thickness defined in protocol by endoscopy and endoscopic ultrasonography at screening.
- •3) Patients with active multiple cancers. However, patients with asynchronous or synchronous multiple cancer who doesn't require systemic therapy for at least 6 months after consent obtaining, or on whom complete cure can be expected with a local therapy such as endoscopic therapy, is handled as eligible.
- •4) Patients with a poorly controlled severe complication.
- •5) Patients with an uncontrolled infection.
- •6) Patients with a history of significant infusion reaction (greater than Grade 3) to cetuximab
- •7) Patients who had received chemotherapy, administration of cetuximab or RT within 4 weeks before enrollment.
- •8) Patients needing ophthalmological examination or surgical operation etc., in which exposure to strong light is foreseeable, within 4 weeks after administration of the investigational drug.
- •9) Pregnant or breastfeeding female patients.
- •10) Patients who are judged by the principal investigator as ineligible to be administered the investigational drug, or in whom the principal investigator judges that laser illumination cannot be performed safely.
- •11) Patients who have experienced ASP-1929 against esophageal cancer in the past.
研究者
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