高级检索
当前位置: 首页 > 详情页

Sintilimab combined with bevacizumab in relapsed/persistent ovarian clear cell carcinoma (INOVA): an investigator-initiated, multicentre clinical trial - a study protocol of clinical trial

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

单位: [1]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Minist Educ,Canc Biol Res Ctr,Key Lab,Wuhan,Hubei,Peoples R China [2]Wuhan Union Hosp, Dept Gynecol Oncol, Wuhan, Hubei, Peoples R China [3]Shandong Univ, Dept Obstet & Gynecol, Qilu Hosp, Jinan, Shandong, Peoples R China
出处:
ISSN:

关键词: immunology gynaecological oncology therapeutics

摘要:
Background Ovarian clear cell carcinoma (OCCC) has an abysmal prognosis with a median overall survival (OS) of 25.3 months because of a low response to chemotherapy. The 5-year disease-specific survival rate after recurrence is 13.2%, with more than two-thirds of the patients dying within a year. Therefore, it is urgent to explore new therapeutic options for OCCC. Based on the characteristic immune-suppressive tumour microenvironment derived from the gene expression profile of OCCC, the combination of immunoantiangiogenesis therapy might have certain efficacy in recurrent/persistent OCCC. This trial aims to evaluate the efficacy and safety of sintilimab and bevacizumab in patients who have failed platinum-containing chemotherapy with recurrent or persistent OCCC. Method and analysis In this multicentre, single-arm, open-label, investigator-initiated clinical trial, 38 patients will be assigned to receive sintilimab 200 mg plus bevacizumab 15 mg/kg every 3 weeks. The eligibility criteria include histologically diagnosed patients with recurrent or persistent OCCC who have been previously treated with at least one-line platinum-containing chemotherapy; patients with Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with an expected survival greater than 12 weeks. The exclusion criteria include patients previously treated with immune checkpoint inhibitor and patients with contraindications of bevacizumab and sintilimab. The primary endpoint is the objective response rate. The secondary endpoints are progression-free survival, time to response, duration of response, disease control rate, OS, safety and quality of life. Statistical significance was defined as p<0.05. Ethics and dissemination This trial was approved by the Research Ethics Commission of Tongji Medical College of Huazhong University of Science and Technology (2020-S337). The protocol of this study is registered at www. clinicaltrials.gov. The trial results will be published in peer-reviewed journals and at conferences.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2021]版:
大类 | 4 区 医学
小类 | 3 区 医学:内科
最新[2025]版:
大类 | 4 区 医学
小类 | 4 区 医学:内科
JCR分区:
出版当年[2020]版:
Q2 MEDICINE, GENERAL & INTERNAL
最新[2024]版:
Q2 MEDICINE, GENERAL & INTERNAL

影响因子: 最新[2024版] 最新五年平均 出版当年[2020版] 出版当年五年平均 出版前一年[2019版] 出版后一年[2021版]

第一作者:
第一作者单位: [1]Huazhong Univ Sci & Technol,Tongji Med Coll,Tongji Hosp,Minist Educ,Canc Biol Res Ctr,Key Lab,Wuhan,Hubei,Peoples R China
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:622 今日访问量:0 总访问量:452 更新日期:2025-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)