Evidence map›Paper›PMID 38961439›Full record

ArticleTrials2024

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.

Jee Soo Park, Jongchan Kim, Jinhyung Jeon, Jongsoo Lee, Won Sik Jang, Seung Hwan Lee, Woong Kyu Han, Young Deuk Choi, Kyo Chul Koo, Kang Su Cho and 2 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05753839 (The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05753839 narecruitingnot on this map

The Role of Cytoreductive Nephrectomy in Metastatic Renal Cell Carcinoma in Immuno-oncology Era: SEVURO-CN Trial

TypeinterventionalSponsorYonsei UniversityRan2023 to 2031Enrolled40ConditionsKidney Cancer, Clear Cell Renal Cell Carcinoma Metastatic, Synchronous NeoplasmArmsCytoreductive nephrectomy±metastasectomy, Human-derived materials sampling
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Article
  3. Role of Cytoreductive Nephrectomy in the Immune Checkpoint Inhibitor Era: A Multicenter Collaborative Study.International journal of urology : official journal of the Japanese Urological Association · 2025
    Article
  4. Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Jee Soo ParkDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Jongchan KimDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Jinhyung JeonDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Jongsoo LeeDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Won Sik JangDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Seung Hwan LeeDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Woong Kyu HanDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Young Deuk ChoiDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Kyo Chul KooDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Kang Su ChoDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Byung Ha ChungDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea.
Won Sik HamDepartment of Urology and Urological Science Institute, Yonsei University College of Medicine, Seoul, South Korea. uroham@yuhs.ac.ORCID http://orcid.org/0000-0003-2246-8838

Funding

Korean Urological Surgery Research Society DH2022-12
6 · The paper itself

Abstract

backgroundThe 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.

methodsThis 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 registrationClinicalTrials.gov, NCT05753839. Registered on 3 March 2023.

Indexed as

Carcinoma, Renal CellCytoreduction Surgical ProceduresKidney NeoplasmsMulticenter Studies as TopicNephrectomyRandomized Controlled Trials as TopicAdultAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansImmune Checkpoint InhibitorsIpilimumabNivolumabProspective StudiesTime FactorsTreatment OutcomeImmune Checkpoint InhibitorsIpilimumabNivolumabCytoreductive nephrectomyImmune checkpoint inhibitorsIpilimumabKidney neoplasmsNivolumabProspective studiesRenal cell carcinoma

Identifiers

PMID38961439
PMCPMC11223430

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.