Evidence map›Paper›PMID 39999445›Full record

Trial reportThe Journal of urology2025

A Phase 2 Study of Tislelizumab as Neoadjuvant Treatment of Cisplatin-Ineligible High-Risk Upper Tract Urothelial Carcinoma.

Jiwei Huang, Xingyun Cai, Cheoklong Ng, Yuansheng Luo, Qiong Chen, Zaoyu Wang, Keying Qiao, Wen Kong, Jin Zhang, Yonghui Chen and 6 more

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of urology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04672330 (A Phase II Study of Tislelizumab), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

NCT04672330 phase2completednot on this map

A Phase II Study of Tislelizumab(T) as Neoadjuvant Treatment for Cisplatin-ineligible High Risk Upper Tract Urothelial Carcinoma (UTUC)

TypeinterventionalSponsorRenJi HospitalRan2020 to 2023Enrolled16ConditionsNeoadjuvant Immunotherapy of Cisplatin-ineligible High Risk Upper Urinary Tract Urothelial CarcinomaArmsTislelizumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Jiwei HuangDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.ORCID 0000-0002-1463-670X
Xingyun CaiDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Cheoklong NgDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yuansheng LuoDepartment of Radiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Qiong ChenDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Zaoyu WangDepartment of Pathology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Keying QiaoSchool of Life Sciences and Technology, Tongji University, Shanghai, China.
Wen KongDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Jin ZhangDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yonghui ChenDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Wei Zhang3D Medicines Inc, Shanghai, China.
Jiyang Zhang3D Medicines Inc, Shanghai, China.
Dadong Zhang3D Medicines Inc, Shanghai, China.
Guangyu WuDepartment of Radiology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Haige ChenDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Wei XueDepartment of Urology, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe investigated the efficacy and safety of tislelizumab as neoadjuvant therapy in patients with cisplatin-ineligible high-risk upper tract urothelial carcinoma (UTUC). MATERIALS AND

methodsIn this single-arm phase 2 trial (NCT04672330), 20 patients with high-risk UTUC were enrolled. Eligibility criteria included high-risk UTUC (defined as high-grade UTUC confirmed by endoscopic biopsy or urinary cytology, radiographic evidence of invasion [cT2-T4N0-2M0], and/or hydronephrosis), an Eastern Cooperative Oncology Group performance status of 0 to 2, no previous systemic therapy, and cisplatin ineligibility. Patients received neoadjuvant tislelizumab before radical surgery. Contrast-enhanced MRI was performed before the third dose and again before surgery. The primary end point was pathological complete response rate (ypT0N0). Secondary end points included pathological response rate (≤ypT1N0), objective response rate, disease-free survival, safety profile, and perioperative complications. Multiplex immunofluorescence assessed immune cell populations in the tumor microenvironment.

resultsAmong the 20 patients, 13 underwent radical nephroureterectomy, 1 received endoscopic ablation, and 3 had segmental ureteral resection. Three patients declined surgery because of disease progression or adverse events. The pathological complete response rate was 20%, with 45% of patients restaged to ≤ pT1. Median disease-free survival and overall survival were not reached. Grade 3/4 treatment-related adverse event occurred in 15% of patients. MRI analysis revealed higher apparent diffusion coefficient entropy in patients with partial response. Exploratory analysis showed increased PD-L1

conclusionsNeoadjuvant tislelizumab showed promising efficacy and manageable toxicity in patients with high-risk, cisplatin-ineligible UTUC. Increased apparent diffusion coefficient entropy on MRI and the presence of PD-L1

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Transitional CellKidney NeoplasmsNeoadjuvant TherapyUreteral NeoplasmsAgedAged, 80 and overCisplatinFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedCisplatintislelizumabneoadjuvant treatmenttislelizumabupper tract urothelial carcinoma

Identifiers

PMID39999445
PMCPMC12708035

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.