Evidence map›Paper›PMID 39777450›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2025

Phase II Pilot Trial of Tislelizumab plus Low-Dose Nab-Paclitaxel for Extensive Very High-Risk Non-Muscle-Invasive Bladder Cancer.

Yunkai Qie, Shiwang Huang, Chong Shen, Zhouliang Wu, La Da, Kaipeng Jia, Zhe Zhang, Gangjian Zhao, Lili Wang, Guoping Xu and 15 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. The Role of Natural Compounds in Bladder Urothelial Carcinoma Treatment.International journal of molecular sciences · 2026
    Review
  4. Review
  5. 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

25 authors.

Yunkai Qie *Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0001-7848-3653
Shiwang Huang *Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0002-3941-2892
Chong Shen *Department of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0005-1580-1577
Zhouliang WuDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0001-2009-4468
La DaDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0003-3625-6975
Kaipeng JiaDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0003-0306-2031
Zhe ZhangDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0002-3938-4190
Gangjian ZhaoDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0003-3876-4308
Lili WangDepartment of Medical Oncology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0002-5022-9634
Guoping XuDepartment of Radiology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0003-8132-8656
Yang ZhaoDepartment of Radiology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0003-4656-172X
Rui LiangDepartment of Pathology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0002-5948-7517
Jianing GuoDepartment of Pathology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0001-8809-195X
Changping LiDepartment of Health Statistics, School of Public Health, Tianjin Medical University, Tianjin, China.ORCID 0000-0002-8690-6748
Hua DongDepartment of Nuclear Medicine, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0001-3064-4777
Man LiDepartment of Gastroenterology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0001-7222-3527
Hongjun LiDepartment of Rheumatology and Immunology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0002-1784-3605
Houyuan ChenDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0009-8191-7550
Dawei TianDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0003-1428-4422
Changli WuDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0007-7215-7866
Wei ZhangDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0009-6420-9499
Zesheng AnDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0001-6055-613X
Haitao WangDepartment of Medical Oncology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0002-5972-1393
Yuanjie NiuTianjin Key Laboratory of Urology, Tianjin Institute of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0009-0001-8271-9021
Hailong HuDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.ORCID 0000-0001-8675-5524

Funding

the Clinical Medicine Research Project fund of the Second Hospital of Tianjin Medical University 2023LC03the Scientific Research Project fund of Tianjin Municipal Education Commossion 2022ZD069the Talent Cultivation Project of the Department of Urology, the Second Hospital of Tianjin Medical University MNRC202313the Tianjin Institute of Urology Talent Funding Program MYSRC202310the Tianjin Municipal Health Industry Key Project fund TJWJ2022XK014the Youth Fund of the Second Hospital of Tianjin Medical University 2022ydey15
6 · The paper itself

Abstract

purposeCombinations of immune checkpoint inhibitors and nab-paclitaxel have improved outcomes in advanced urothelial carcinoma and muscle-invasive bladder cancer. This study evaluates the safety and efficacy of tislelizumab combined with low-dose nab-paclitaxel in extensive very high-risk non-muscle-invasive bladder cancer. PATIENTS AND

methodsTRUCE-02 was a single-arm phase II trial that included 63 patients with visually incomplete resection and/or high-volume high-grade T1 tumors (with or without carcinoma in situ) who were ineligible for or declined radical cystectomy. Patients received intravenous tislelizumab (200 mg on day 1) and nab-paclitaxel (200 mg on day 2) every 3 weeks, with assessment approximately 3 months after initial administration. The primary endpoint was the complete response (CR) rate of high-risk disease. Main secondary endpoints included safety and duration of CR.

resultsThe safety analysis included all 63 patients, and the efficacy analysis included 59 patients. Thirty-seven patients (62.7%; 95% confidence interval, 49.1%-75.0%) achieved a CR of high-risk disease, with a 24-month sustained response rate of 96.3% (95% confidence interval, 89.4%-100.0%). Grade 3 to 4 treatment-related adverse events occurred in nine patients (14%), with no fatal events reported.

conclusionsTislelizumab plus low-dose nab-paclitaxel was well tolerated and showed promising antitumor activity, making it a potential alternative for patients with extensive very high-risk non-muscle-invasive bladder cancer who are ineligible for or decline radical cystectomy.

Indexed as

AlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsPaclitaxelUrinary Bladder NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedNeoplasm InvasivenessNon-Muscle Invasive Bladder NeoplasmsPilot ProjectsTreatment Outcome130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedPaclitaxeltislelizumab

Identifiers

PMID39777450
PMCPMC11873803

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.