JPRN-jRCT2080224829已完成3 期
A Phase III, Randomized, Multi-Center, Double-Blind, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With and Following Chemoradiotherapy Compared to Chemoradiotherapy Alone for Treatment in Women With Locally Advanced Cervical Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 72
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
- Female
入选标准
- •2. Aged at least 18 years
- •3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO (2009) Stages IB2 to IIB node positive or FIGO (2009) IIIA-IVA any node
- •4. No prior chemotherapy or radiotherapy for cervical cancer
- •5. WHO/ECOG performance status of 0-1
- •6. At least 1 lesion, not previously irradiated, that q
- •ualifies as a RECIST 1.1 Target Lesion at baseline
排除标准
- •1. Diagnosis of small cell (neuroendocrine) histology or mucinous adenocarcinoma cervical cancer
- •2. Intent to administer a fertility-sparing treatment regimen
- •3. Undergone a previous hysterectomy
- •4. Evidence of metastatic disease per RECIST 1.1 including lymph nodes 15 mm (short axis) or more above the L1 cephalad body in the inguinal region or outside the planned radiation field
- •5. History of allogeneic organ transplantati
- •6. Active or prior documented autoimmune or inflammatory disorders
- •7. Uncontrolled intercurrent illness
- •8.History of another primary malignancy and active primary immunodeficiency
研究者
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