JPRN-jRCT1061230031招募中2 期
Phase II study of FOLFOX for unresectable pancreatic cancer patients with germline BRCA pathogenic variant
Ioka Tatsuya0 个研究点目标入组 33 人开始时间: 2023年6月29日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
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) Pathologically confirmed pancreatic cancer.
- •2) Patients with (presumed) germline pathogenic variant of BRCA1 or BRCA2
- •3) Unresectable or recurrent cancer
- •4) Age is 18 years or older
- •5) ECOG performance status of 0 or 1.
- •6) Patients determined by their physician to be ineligible for FOLFIRINOX therapy.
- •7) No previous chemotherapy using platinum agents for pancreatic cancer.
- •8) No previous chemotherapy using PARP inhibitor.
- •9) Adequate organ functions.
- •10) Written informed consent.
排除标准
- •1) Synchronous or metachronous malignancies.
- •2) Central nerve system metastasis.
- •3) Pleural effision or ascites requiring puncture or drainage.
- •4) Grade 2 or higher peripheral sensory or motor neurophathy.
- •5) Received blood transfusions, blood products, or G-CSF within 2 weeks.
- •6) Chronic treatment with corticosteroids or other immunosuppressive agents.
- •7) Interstitial pneumonia, pulmonary fibrosis.
- •8) Serious co-existing illness.
- •9) Active infection except for viral hepatitis.
- •10) Pregnant or lactating women, or women of childbearing potential.
- •11) Psychiatric disease.
研究者
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