JPRN-jRCT1080223615已完成1 期
Phase I Study of TBI-1401(HF10) Plus Chemotherapy in Patient with Unresectable Pancreatic Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
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) Patients with histologically or cytologically confirmed unresectable pancreatic cancer (stage III or IV) based on the General Rules for the Study of Pancreatic Cancer (The 7th edition). Patient(stage III) who never received anti-cancer therapy (radiation therapy, chemotherapy, immunotherapy, surgery, clinical trials) or patient (stage IV) who previously received gemcinabine-base therapy.
- •2) Patients with primary lesion will be intratumorally injectable for TBI-1401(HF10) by EUS (endoscopic ultrasound).
- •3) Patients must have at least one measurable lesion evaluated by Computed Tomography (CT) scan on RECIST ver.1.1 at pre-treatment.
- •4) Patients must have a life expectancy greater than or equal to 12 weeks.
- •5) Patients must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0-1.
排除标准
- •1) Patients receiving anti-herpes medication within 1 week prior to TBI-1401(HF10) treatment (except local treatment such as ointment).
- •2) Patients with a significant tumor bleeding or coagulation abnormality that could not treat intratumoral injection or biopsy in safe.
- •3) Patients receiving other clinical study drugs or products within 4 weeks prior to initiating study treatment.
- •4) Patients with active CNS metastases.
- •5) Patients with ascites, except acceptable mild ascites.
研究者
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