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Biomarker-driven targeted therapy in patients with recurrent platinum-resistant epithelial ovarian cancer (BRIGHT): protocol for an open-label, multicenter, umbrella study

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单位: [1]National Clinical Research Center for Obstetrics and Gynecology,Department of Gynecological Oncology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [2]Cancer Biology Research Center (Key Laboratory of the Ministry of Education,Hubei Provincial Key Laboratory of Tumor Invasion and Metastasis),Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [3]Department of Gynecology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Beijing Cancer Hospital, Beijing, China [4]Department of Gynecology and Obstetrics, Qilu Hospital of Shandong University, Jinan, China [5]Department of Gynecologic Oncology, Shandong Cancer Hospital and Institute, Jinan, China [6]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [7]Department of Gynecological Oncology, Anhui Provincial Cancer Hospital, Hefei, China [8]Gynecological Oncology Center, Chongqing University Cancer Hospital, Chongqing, China [9]Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China [10]Department of Gynecology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China [11]Department of Obstetrics and Gynecology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China [12]Department of Gynecologic Oncology, Hubei Cancer Hospital, Wuhan, China
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Platinum-resistant, recurrent ovarian cancer has an abysmal prognosis with limited treatment options. Poly-(ADP-ribose)-polymerase (PARP), angiogenesis, and immune checkpoint inhibitors might improve the outcomes of platinum-resistant, recurrent ovarian cancer, but accurate patient selections for those therapies remain a significant clinical challenge.To evaluate the efficacy and safety of biomarker-driven combinatorial therapies of pamiparib, tislelizumab, bevacizumab, and nab-paclitaxel in platinum-resistant, recurrent ovarian cancer.A precision medicine combination of PARP inhibitors, anti-angiogenic therapy, immunotherapy, and chemotherapy will improve disease outcomes of platinum-resistant, recurrent ovarian cancer by accounting for genomic and immunologic features.The BRIGHT Trial is a prospective, open-label, multicenter, phase II, umbrella study planning to enroll 160 patients with serous, endometrioid, or clear cell platinum-resistant, recurrent ovarian cancer from 11 clinical centers in China. Patients are assigned to one of three experimental arms based on biomarkers. Patients with BRCA1/2 mutations will receive pamiparib plus bevacizumab (arm 1, n=40) regardless of CD8+ tumor-infiltrating lymphocytes count. Patients with wild-type BRCA1/2 (BRCAwt) and ≥3 CD8+ tumor-infiltrating lymphocytes count will receive the combination of tislelizumab, bevacizumab, and nab-paclitaxel (arm 2, n=50), while BRCAwt patients with <3 CD8+ tumor-infiltrating lymphocytes count will receive bevacizumab plus dose-dense nab-paclitaxel (arm 3, n=50). After completing patient enrollment in arm 2, another 20 BRCAwt patients with ≥3 CD8+ tumor-infiltrating lymphocytes count will be included as an arm 2 expansion. Treatment will continue until disease progression or intolerable toxicity, and all adverse events will be recorded.Eligible patients include those aged ≥18 with serous, endometrioid, or clear cell ovarian cancer, platinum-resistant recurrence, and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.Objective response rate (ORR) assessed by the investigators by the RECIST 1.1 criteria.160 patients.Recruitment is estimated to be completed by 2024 and results may be published by 2027.ClinicalTrials.gov: NCT05044871.© IGCS and ESGO 2024. No commercial re-use. See rights and permissions. Published by BMJ.

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出版当年[2023]版:
大类 | 2 区 医学
小类 | 3 区 妇产科学 3 区 肿瘤学
最新[2025]版:
大类 | 3 区 医学
小类 | 3 区 妇产科学 3 区 肿瘤学
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出版当年[2022]版:
Q1 OBSTETRICS & GYNECOLOGY Q2 ONCOLOGY
最新[2024]版:
Q1 OBSTETRICS & GYNECOLOGY Q1 ONCOLOGY

影响因子: 最新[2024版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

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第一作者单位: [1]National Clinical Research Center for Obstetrics and Gynecology,Department of Gynecological Oncology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [2]Cancer Biology Research Center (Key Laboratory of the Ministry of Education,Hubei Provincial Key Laboratory of Tumor Invasion and Metastasis),Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China
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通讯机构: [1]National Clinical Research Center for Obstetrics and Gynecology,Department of Gynecological Oncology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China [2]Cancer Biology Research Center (Key Laboratory of the Ministry of Education,Hubei Provincial Key Laboratory of Tumor Invasion and Metastasis),Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan,China
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