Nimotuzumab plus induction chemotherapy followed by radiotherapy/concurrent chemoradiotherapy plus nimotuzumab for locally advanced nasopharyngeal carcinoma: protocol of a multicentre, open-label, single-arm, prospective phase II trial.
Nimotuzumab plus induction chemotherapy followed by radiotherapy/concurrent chemoradiotherapy plus nimotuzumab for locally advanced nasopharyngeal carcinoma: protocol of a multicentre, open-label, single-arm, prospective phase II trial.
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DOI：
10.1136/bmjopen-2021-051594
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发表时间：
2022-08-25
期刊：
影响因子：
2.9
通讯作者：
Zeng, Lei
中科院分区：
文献类型：
--
作者：
Yuan, Jing-Jing;Ding, Jian-Wu;Li, Jin-Wei;Hu, Rong-Huan;Gong, Dan;Hu, Jia-Li;Zhu, Kai-Bin;Liu, Yan;Ding, Yu-Hai;Wei, Jia-Wang;Zeng, Jian-Lun;Lu, Zhi-Bing;Yin, Wei-Hua;Ai, Su-Fen;Zha, Guo-Hua;Zhang, Zhi-Lin;Zou, Rui;Zeng, Lei
表皮生长因子受体（EGFR）是鼻咽癌（NPC）的治疗靶点。抗EGFR单克隆抗体、诱导化疗(ICT)、同步化疗和放疗治疗鼻咽癌的最佳组合方式仍不明确。之前的研究都没有根据 ICT 加抗 EGFR 单克隆抗体的疗效进行分层来制定后续治疗策略。本研究旨在通过评估该治疗方案的疗效是否不劣于ICT加同步放化疗（历史对照），以增加ICT疗效不佳患者的治疗强度，并降低ICT疗效良好患者的治疗毒性。经病理证实的临床III-IVA期（第八届美国癌症联合委员会/国际癌症控制联盟分期系统）的WHO II/III型鼻咽癌患者将被纳入该研究。他们将接受 ICT 加尼妥珠单抗 (NTZ)，然后接受放疗加 NTZ 或同步放化疗加 NTZ（根据 ICT 加 NTZ 的疗效分层）。主要终点是 3 年无失败生存率；次要终点是3年总生存率、无远处转移生存率和局部区域无复发生存率、肿瘤和治疗毒性的短期缓解率。本研究方案已获得南昌大学第二附属医院伦理委员会批准。我们的研究结果将在同行评审的期刊上传播。实施策略已到位，以确保参与者的隐私和机密。 ChiCTR2000041139。
Epidermal growth factor receptor (EGFR) is a therapeutic target in nasopharyngeal carcinoma (NPC). The optimal combined modality of optimal combined modality of anti-EGFR monoclonal antibodies, induction chemotherapy (ICT), concurrent chemotherapy and radiotherapy for NPC remains poorly defined. None of previous studies have developed subsequent treatment strategies on the basis of stratification according to the efficacy following ICT plus anti-EGFR mAbs. This study aims to increase treatment intensity for patients with poor efficacy of ICT and reduce treatment toxicity for patients with favourable efficacy of ICT by assessing whether the efficacy of this treatment regimen is non-inferior to ICT plus concurrent chemoradiotherapy (historic controls). Pathology-confirmed WHO type II/III NPC patients at clinical stage III–IVA (eighth American Joint Committee on Cancer/Union for International Cancer Control staging system) will be included in the study. They will receive ICT plus nimotuzumab (NTZ), followed by radiotherapy plus NTZ or concurrent chemoradiotherapy plus NTZ (stratified based on the efficacy of ICT plus NTZ). The primary endpoint is 3-year failure-free survival rate; while the secondary endpoints are 3-year overall survival rate, distant metastasis-free survival rate and locoregional recurrence-free survival rate, and short-term remission rate of tumour and treatment toxicity. The study protocol has been approved by the Ethics Committee of the Second Affiliated Hospital of Nanchang University. Our findings will be disseminated in a peer-reviewed journal. Implementation strategies are in place to ensure privacy and confidentiality of participants. ChiCTR2000041139.
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影响因子：
50.5
作者：
Zhao, C.;Miao, J.;Xie, C.
通讯作者：
Xie, C.
新辅助化疗后同步放化疗与单独同步放化疗治疗局部晚期鼻咽癌：一项 III 期多中心随机对照试验。
影响因子：
8.4
作者：
Cao, Su-Mei;Yang, Qi;Hong, Ming-Huang
通讯作者：
Hong, Ming-Huang
II-IVb 期鼻咽癌同步放化疗联合或不联合抗 EGFR 靶向治疗：大队列和长期随访的回顾性分析
影响因子：
12.4
作者：
You R;Hua YJ;Liu YP;Yang Q;Zhang YN;Li JB;Li CF;Zou X;Yu T;Cao JY;Zhang MX;Jiang R;Sun R;Mo HY;Guo L;Cao KJ;Lin AH;Sun Y;Qian CN;Ma J;Chen MY
通讯作者：
Chen MY
影响因子：
6.6
作者：
Sigismund S;Avanzato D;Lanzetti L
通讯作者：
Lanzetti L
DOI：
10.1002/hed.10307
发表时间：
2003-10-01
影响因子：
2.9
作者：
Ma, BBT;Poon, TCW;Chan, ATC
通讯作者：
Chan, ATC