EUCTR2018-000366-11-FR
进行中（未招募）
1 期
A phase III randomized, double-blinded trial of platinum-based chemotherapy with or without atezolizumab followed by niraparib maintenance with or without atezolizumab in patients with recurrent ovarian, tubal or peritoneal cancer and platinum treatment-free interval (TFIp) >6 months. - ANITA
Grupo Español de Investigación en Cáncer de Ovario (GEICO)0 个研究点目标入组 414 人2019年11月18日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Recurrent ovarian, tubal or peritoneal cancer
- 发起方
- Grupo Español de Investigación en Cáncer de Ovario (GEICO)
- 入组人数
- 414
- 状态
- 进行中（未招募）
- 最后更新
- 5年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Patients \= 18 years old
- •2\. Life expectancy \=3 months
- •3\. Signed informed consent and ability to comply with treatment and follow\-up
- •4\. Histologically confirmed diagnosis (cytology alone excluded) of high\- grade serous or endometrioid ovarian, primary peritoneal or tubal carcinoma. In addition, mixed histologies with predominat high grade serous or endometrioid, or undifferentiated adenocarcinoma of the ovary are allowed
- •5\. BRCA mutational status is known (germline or somatic)
- •6\. Relapsed disease more than 6 months after the last platinum dose:
- •7\. No more than 2 prior lines of chemotherapy are allowed, and the last one must contain a platinum\-based regimen
- •8\. At least one measurable lesion to assess response by RECIST v1\.1 criteria.
- •9\. Mandatory de novo tumor biopsy (collected within 3mths prior to randomization) sent to central laboratory as a FFPE sample for PD\-L1 status determination for randomization
- •10\. Two additional tumour samples are needed. Archival tumor sample must be available for exploratory PD\-L1 testing in archival tissue and archival or fresh tissue sample for biomarkers must also be available.
排除标准
- •1\.Non\-epithelial tumor of the ovary, the fallopian tube or the peritoneum
- •2\.Ovarian tumors of low malignant potential or low grade
- •3\.Other malignancy within the last 5 years except curatively treated non\-melanoma skin cancer, in situ cancer of the cervix and ductal carcinoma in situ (DCIS)
- •4\.Major surgery or patients who have not completely recovered from the effects of any major surgery at randomization
- •5\.Core biopsy or other minor surgical procedure.
- •6\.Administration of other CT drugs, anticancer therapy or anti\-neoplastic hormonal therapy, or TTT with other investigational agents or devices
- •7\.Palliative radiotherapy
- •8\.Current or recent chronic use of aspirin or clopidogrel
- •9\.Clinically significant cardiovascular disease
- •10\.Resting ECG with QTc \>470 msec on 2 or more time points within a 24 h period or family history of long QT syndrom
结局指标
主要结局
未指定
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