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本文引用的文献

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Gut microbiota-mediated nucleotide synthesis attenuates the response to neoadjuvant chemoradiotherapy in rectal cancer.肠道微生物群介导的核苷酸合成减弱了直肠癌对新辅助放化疗的反应。
Cancer Cell. 2023 Jan 9;41(1):124-138.e6. doi: 10.1016/j.ccell.2022.11.013. Epub 2022 Dec 22.
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Hypofractionated, 3-week, preoperative radiotherapy for patients with soft tissue sarcomas (HYPORT-STS): a single-centre, open-label, single-arm, phase 2 trial.软组织肉瘤患者的短程、3 周术前放疗(HYPORT-STS):一项单中心、开放标签、单臂、Ⅱ期临床试验。
Lancet Oncol. 2022 Dec;23(12):1547-1557. doi: 10.1016/S1470-2045(22)00638-6. Epub 2022 Nov 4.
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Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.软组织肉瘤,第 2.2022 版,NCCN 肿瘤学临床实践指南。
J Natl Compr Canc Netw. 2022 Jul;20(7):815-833. doi: 10.6004/jnccn.2022.0035.
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Commensal bacteria and fungi differentially regulate tumor responses to radiation therapy.共生细菌和真菌可差异化调节肿瘤对放射疗法的反应。
Cancer Cell. 2021 Sep 13;39(9):1202-1213.e6. doi: 10.1016/j.ccell.2021.07.002. Epub 2021 Jul 29.
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Radiation Therapy for Treatment of Soft Tissue Sarcoma in Adults: Executive Summary of an ASTRO Clinical Practice Guideline.成人软组织肉瘤放射治疗:ASTRO 临床实践指南执行摘要。
Pract Radiat Oncol. 2021 Sep-Oct;11(5):339-351. doi: 10.1016/j.prro.2021.04.005. Epub 2021 Jul 26.
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Immune-related toxicities of checkpoint inhibitors: mechanisms and mitigation strategies.检查点抑制剂的免疫相关毒性:机制与缓解策略。
Nat Rev Drug Discov. 2022 Jul;21(7):495-508. doi: 10.1038/s41573-021-00259-5. Epub 2021 Jul 27.
7
Soft tissue and visceral sarcomas: ESMO-EURACAN-GENTURIS Clinical Practice Guidelines for diagnosis, treatment and follow-up.软组织和内脏肉瘤:ESMO-EURACAN-GENTURIS诊断、治疗及随访临床实践指南
Ann Oncol. 2021 Nov;32(11):1348-1365. doi: 10.1016/j.annonc.2021.07.006. Epub 2021 Jul 22.
8
Gut microbiota signatures are associated with toxicity to combined CTLA-4 and PD-1 blockade.肠道微生物组特征与 CTLA-4 和 PD-1 联合阻断的毒性相关。
Nat Med. 2021 Aug;27(8):1432-1441. doi: 10.1038/s41591-021-01406-6. Epub 2021 Jul 8.
9
Efficacy and Safety of Hypofractionated Preoperative Radiotherapy for Primary Locally Advanced Soft Tissue Sarcomas of Limbs or Trunk Wall.肢体或躯干壁原发性局部晚期软组织肉瘤术前短程放疗的疗效与安全性
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10
Radiation-induced neoantigens broaden the immunotherapeutic window of cancers with low mutational loads.辐射诱导的新生抗原拓宽了低突变负荷癌症的免疫治疗窗口。
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新辅助放疗和肿瘤内免疫治疗联合手术治疗肢体软组织肉瘤的临床试验。

Neo-adjuvant radiation and intratumoral immunotherapy followed by surgery- trial for extremity soft tissue sarcoma.

机构信息

The Comprehensive Cancer Center of Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.

Department of Orthopaedics, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, China.

出版信息

Future Oncol. 2024;20(30):2233-2240. doi: 10.1080/14796694.2024.2385291. Epub 2024 Sep 13.

DOI:10.1080/14796694.2024.2385291
PMID:39268916
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11508951/
Abstract

Extremity soft tissue sarcoma (ESTS) is a rare malignant nonepithelial disease, calling for combined modality treatments with surgery to further improve local control rates and long-term survival, especially in patients with multiple local recurrences with or without risk of amputation. In this double-arm, open-label, Phase II clinical trial, we will enroll 30 patients with pathologically confirmed ESTS without nodal involvement or distant metastases. Patients are randomly assigned to the combination treatment group or the radiation monotherapy group. Additionally, tumor and biological samples will be obtained directly before and after neoadjuvant therapy, allowing for studies of immune response and primary drug resistance mechanisms. ChiCTR2200060659 (http://www.chictr.org.cn) (ClinicalTrials.gov).

摘要

肢体软组织肉瘤(ESTS)是一种罕见的恶性非上皮性疾病,需要采用联合治疗模式,包括手术,以进一步提高局部控制率和长期生存率,尤其是对于那些存在多次局部复发且有或无截肢风险的患者。在这项双臂、开放标签、II 期临床试验中,我们将招募 30 名经病理证实且无淋巴结受累或远处转移的 ESTS 患者。患者将被随机分配至联合治疗组或单纯放疗组。此外,将在新辅助治疗前后直接获取肿瘤和生物样本,以进行免疫反应和原发性药物耐药机制的研究。ChiCTR2200060659(http://www.chictr.org.cn)(ClinicalTrials.gov)。