EUCTR2018-002872-42-HU进行中（未招募）1 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 (CALLA). - CALLA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 714
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •2. Aged at least 18 years
- •3. Documented evidence of cervical adenocarcinoma or squamous carcinoma FIGO Stage IB2-IIB Node positive or 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 qualifies as a RECIST 1.1 Target Lesion at baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 571
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 143
排除标准
- •1. Diagnosis of small cell (neuroendocrine) histology 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) above the L1 cephalad body or outside the planned radiation field.
- •5. History of allogeneic organ transplantation
- •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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