دورية أكاديمية
أعرض في EDS

The role of cytoreductive nephrectomy in metastatic renal cell carcinoma in immune-oncology era (SEVURO-CN): study protocol for a multi-center, prospective, randomized trial.

التفاصيل البيبلوغرافية
العنوان: The role of cytoreductive nephrectomy in metastatic renal cell carcinoma in immune-oncology era (SEVURO-CN): study protocol for a multi-center, prospective, randomized trial.
المؤلفون: Park JS; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea., Kim J; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.; Department of Urology, Yongin Severance Hospital, Yonsei University Health System, Seoul, South Korea., Jeon J; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.; Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea., Lee J; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea., Jang WS; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea., Lee SH; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea., Han WK; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea., Choi YD; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea., Koo KC; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.; Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea., Cho KS; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.; Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea., Chung BH; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.; Department of Urology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea., Ham WS; Department of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea. uroham@yuhs.ac.
المصدر: Trials [Trials] 2024 Jul 03; Vol. 25 (1), pp. 447. Date of Electronic Publication: 2024 Jul 03.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Carcinoma, Renal Cell*/surgery , Carcinoma, Renal Cell*/drug therapy , Carcinoma, Renal Cell*/secondary , Kidney Neoplasms*/pathology , Kidney Neoplasms*/drug therapy , Kidney Neoplasms*/surgery , Nephrectomy*/adverse effects , Nephrectomy*/methods , Cytoreduction Surgical Procedures*/adverse effects , Randomized Controlled Trials as Topic* , Multicenter Studies as Topic*, Humans ; Prospective Studies ; Nivolumab/therapeutic use ; Nivolumab/adverse effects ; Immune Checkpoint Inhibitors/therapeutic use ; Immune Checkpoint Inhibitors/adverse effects ; Ipilimumab/therapeutic use ; Ipilimumab/adverse effects ; Treatment Outcome ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Time Factors ; Female ; Adult
مستخلص: Background: The role of cytoreductive nephrectomy (CN) in the treatment of metastatic renal cell carcinoma (mRCC) remains unclear in the immuno-oncology (IO) era. The results of two randomized trials, CARMENA and SURTIME, questioned the role and timing of CN. However, despite the latest advances in the systemic treatment of mRCC, previous trials have only used targeted therapy, and no studies have fully investigated the role of CN in immune checkpoint inhibitor (CPI) settings, and there is an urgent need for future studies to better define the role and timing of CN.
Methods: This study is an open-label, multi-center, parallel, prospective, randomized, interventional clinical study to evaluate the efficacy of CN in combination with CPIs in mRCC patients with International mRCC Database Consortium (IMDC) intermediate- and poor-risk. Synchronous mRCC patients with ≤ 3 IMDC risk features will be randomly allocated to three groups (1, upfront CN; 2, deferred CN; and 3, systemic therapy [ST] only). For ST, the nivolumab plus ipilimumab combination regimen, one of the standard regimens for intermediate- and poor-risk mRCC, is chosen. The primary endpoint is overall survival. The secondary endpoints are progression-free survival, objective response rate, number of participants with treatment-related adverse events, and number of participants with surgical morbidity. We will analyze the genetic mutation profiles of the tumor tissue, circulating tumor DNA, urine tumor DNA, and tumor-infiltrating lymphocytes. The gut and urine microbial communities will be analyzed. The study will begin in 2022 and will enroll 55 patients.
Discussion: This study is one of the few prospective randomized trials to evaluate the benefit of CN in the treatment of synchronous mRCC in the IO era. The SEVURO-CN trial will help identify the role and timing of CN, thereby rediscovering the value of CN.
Trial Registration: ClinicalTrials.gov, NCT05753839. Registered on 3 March 2023.
(© 2024. The Author(s).)
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معلومات مُعتمدة: DH2022-12 Korean Urological Surgery Research Society
فهرسة مساهمة: Keywords: Cytoreductive nephrectomy; Immune checkpoint inhibitors; Ipilimumab; Kidney neoplasms; Nivolumab; Prospective studies; Renal cell carcinoma
سلسلة جزيئية: ClinicalTrials.gov NCT05753839
المشرفين على المادة: 31YO63LBSN (Nivolumab)
0 (Immune Checkpoint Inhibitors)
0 (Ipilimumab)
تواريخ الأحداث: Date Created: 20240703 Date Completed: 20240704 Latest Revision: 20240706
رمز التحديث: 20240706
مُعرف محوري في PubMed: PMC11223430
DOI: 10.1186/s13063-024-08234-2
PMID: 38961439
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-024-08234-2