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替雷利珠单抗用于根治性同步放化疗后病理残留的食管鳞状细胞癌患者巩固治疗:一项多中心、随机、对照II期试验

Tislelizumab for consolidation therapy in patients with pathologically residual Esophageal Squamous Cell Carcinoma after definitive concurrent Chemoradiotherapy: a multicenter, randomized, controlled phase II trial.

作者信息

Meng Xi, Sun Hongfu, Cui Tiantian, Huang Wei

机构信息

The Second Affiliated Hospital of Shandong First Medical University, Tai'an, Shandong, China.

Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong, China.

出版信息

Future Oncol. 2024 Dec;20(40):3397-3402. doi: 10.1080/14796694.2024.2432290. Epub 2024 Nov 26.

DOI:10.1080/14796694.2024.2432290
PMID:39589855
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11776850/
Abstract

Although concurrent Chemoradiotherapy (cCRT) is presently the standard intervention for patients with inoperable, locally advanced Esophageal Squamous Cell Carcinoma (ESCC), it has been associated with poor long-term survival outcomes. Notably, Immune Checkpoint Inhibitors (ICIs) improve the long-term survival of Esophageal Cancer (EC) patients, with manageable Adverse Effects (AEs). Herein, 90 patients with residual pathology after radical simultaneous Radiotherapy (RT) for inoperable/refused-to-operate ESCC were enrolled and randomized into two treatment groups (Chemotherapy+immunotherapy and chemotherapy alone) in a 2:1 ratio. This study will also discuss the value of immunotherapy in improving long-term survival outcomes in patients with pathological residuals after concurrent RT for locally advanced, inoperable ESCC.Clinical trial registration: http://www.chictr.org.cn/identifier is ChiCTR2200063345.

摘要

尽管同步放化疗(cCRT)目前是不可切除的局部晚期食管鳞状细胞癌(ESCC)患者的标准干预措施,但它与较差的长期生存结果相关。值得注意的是,免疫检查点抑制剂(ICIs)可改善食管癌(EC)患者的长期生存,且不良反应(AEs)可控。在此,90例因不可切除/拒绝手术的ESCC接受根治性同步放疗(RT)后有残留病理的患者被纳入研究,并按2:1的比例随机分为两个治疗组(化疗+免疫治疗和单纯化疗)。本研究还将探讨免疫治疗在改善局部晚期、不可切除的ESCC同步放疗后有病理残留患者的长期生存结果方面的价值。临床试验注册:http://www.chictr.org.cn/标识符为ChiCTR2200063345。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb06/11776850/89a816d2a261/IFON_A_2432290_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb06/11776850/89a816d2a261/IFON_A_2432290_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bb06/11776850/89a816d2a261/IFON_A_2432290_F0001_B.jpg

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本文引用的文献

1
First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50).纳武利尤单抗联合伊匹木单抗或化疗对比单纯化疗一线治疗晚期食管鳞癌的日本亚组分析:开放标签、III 期临床试验(CheckMate 648/ONO-4538-50)。
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J Clin Oncol. 2022 Sep 10;40(26):3065-3076. doi: 10.1200/JCO.21.01926. Epub 2022 Apr 20.
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Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial.卡瑞利珠单抗联合化疗对比安慰剂用于治疗晚期或转移性食管鳞癌患者的生存和无进展生存期的影响:ESCORT-1 期随机临床试验。
JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
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Pembrolizumab plus chemotherapy versus chemotherapy alone for first-line treatment of advanced oesophageal cancer (KEYNOTE-590): a randomised, placebo-controlled, phase 3 study.帕博利珠单抗联合化疗与单纯化疗一线治疗晚期食管癌(KEYNOTE-590):一项随机、安慰剂对照、III 期研究。
Lancet. 2021 Aug 28;398(10302):759-771. doi: 10.1016/S0140-6736(21)01234-4.
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Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer.纳武利尤单抗辅助治疗食管或胃食管结合部癌。
N Engl J Med. 2021 Apr 1;384(13):1191-1203. doi: 10.1056/NEJMoa2032125.
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Randomized Phase III KEYNOTE-181 Study of Pembrolizumab Versus Chemotherapy in Advanced Esophageal Cancer.帕博利珠单抗对比化疗用于晚期食管癌的随机 III 期 KEYNOTE-181 研究。
J Clin Oncol. 2020 Dec 10;38(35):4138-4148. doi: 10.1200/JCO.20.01888. Epub 2020 Oct 7.
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Lancet Oncol. 2020 Jun;21(6):832-842. doi: 10.1016/S1470-2045(20)30110-8. Epub 2020 May 13.
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