Evidence map›Paper›PMID 33047430›Full record

Trial reportCancer science2021

Tislelizumab in Asian patients with previously treated locally advanced or metastatic urothelial carcinoma.

Dingwei Ye, Jiyan Liu, Aiping Zhou, Qing Zou, Hanzhong Li, Cheng Fu, Hailong Hu, Jian Huang, Shaoxing Zhu, Jie Jin and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04004221 (A Single-Arm, Multicenter Phase 2 Study of BGB-A317 in Patients With Previously Treated PD-L1+ Locally Advanced or Metastatic Urothelial Bladder Cancer), which is not on this map. Cited by 74 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 4 pooled it
5.7field-weighted citation impact, top 3% of its field
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.

NCT04004221 phase2completednot on this map

A Single-Arm, Multicenter Phase 2 Study of BGB-A317 in Patients With Previously Treated PD-L1+ Locally Advanced or Metastatic Urothelial Bladder Cancer

TypeinterventionalSponsorBeiGeneRan2017 to 2021Enrolled113ConditionsLocally Advanced or Metastatic Urothelial Bladder CancerArmsTislelizumab
3 · Its place in the literature

Who cites it

74 citing papers in PubMed, 4 syntheses or guidelines pooled it, 113 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Immunotherapy for advanced or metastatic urothelial carcinoma.The Cochrane database of systematic reviews · 2023
    Pooled it
  5. Phase II Pilot Trial of Tislelizumab plus Low-Dose Nab-Paclitaxel for Extensive Very High-Risk Non-Muscle-Invasive Bladder Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
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  10. Review
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14 more citing papers are in PubMed but not listed here.

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

20 authors at 16 institutions in 2 countries.

Dingwei YeDepartment of Urology, Fudan University Shanghai Cancer Center, Shanghai, China.
Jiyan LiuDepartment of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.
Aiping ZhouDepartment of Medical Oncology, Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Institute & Hospital, Beijing, China.
Qing ZouDepartment of Medical Oncology, Jiangsu Cancer Hospital, Nanjing, China.
Hanzhong LiDepartment of Urology, Peking Union Medical College Hospital, Beijing, China.
Cheng FuDepartment of Urological Surgical Oncology, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning, China.
Hailong HuDepartment of Urology, The Second Hospital of Tianjin Medical University, Tianjin, China.
Jian HuangDepartment of Urology, Sun Yat-Sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China.
Shaoxing ZhuDepartment of Medical Oncology, Zhejiang Cancer Hospital, Zhejiang, China.
Jie JinDepartment of Urology, Peking University First Hospital, Beijing, China.
Lulin MaDepartment of Urology, Peking University Third Hospital, Beijing, China.
Jianming GuoDepartment of Urology, Zhongshan Hospital, Fudan University, Shanghai, China.
Jun XiaoDepartment of Urology, Anhui Provincial Hospital, Hefei, China.
Se Hoon ParkDepartment of Medicine, Division of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea.
Dahong ZhangDepartment of Urology, Zhejiang Provincial People's Hospital, Zhejiang, China.
Xiusong QiuDepartment of Medical Oncology, BeiGene (Beijing) Co., Ltd, Beijing, China.
Yuanyuan BaoDepartment of Medical Oncology, BeiGene (Beijing) Co., Ltd, Beijing, China.
Lilin ZhangDepartment of Medical Oncology, BeiGene (Beijing) Co., Ltd, Beijing, China.
Wei ShenDepartment of Medical Oncology, BeiGene (Beijing) Co., Ltd, Beijing, China.
Feng BiDepartment of Medical Oncology, West China Hospital, Sichuan University, Chengdu, China.
BeiGene (China) · CNSun Yat-sen University · CNAnhui Provincial Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFudan University Shanghai Cancer Center · CNJiangsu Cancer Hospital · CNLiaoning Cancer Hospital & Institute · CNPeking Union Medical College Hospital · CNPeking University · CNPeking University First Hospital · CNSichuan University · CNSungkyunkwan University · KRTianjin Medical University · CNWest China Hospital of Sichuan University · CNZhejiang Cancer Hospital · CNZhejiang Provincial People's Hospital · CN

Funding

BeiGene, Ltd.
6 · The paper itself

Abstract

Tislelizumab, an anti-programmed death protein-1 (PD-1) monoclonal antibody, was engineered to minimize binding to the FcγR on macrophages to abrogate antibody-dependent phagocytosis, a mechanism of T-cell clearance and potential resistance to anti-PD-1 therapy. This single-arm phase 2 trial (NCT04004221/CTR20170071) assessed the safety, tolerability, and efficacy of tislelizumab in patients with PD-L1-positive urothelial carcinoma who progressed during/following platinum-containing therapy and had no prior PD-(L)1 inhibitor treatment. Patients were considered PD-L1 positive if ≥ 25% of tumor/immune cells expressed PD-L1 when using the VENTANA™ PD-L1 (SP263) assay. The primary endpoint was objective response rate by independent review committee. As of September 16, 2019, 113 patients had a median study follow-up time of 9.4 mo. Most patients (76%) had visceral metastases, including 24% with liver and 23% with bone metastases. Among 104 efficacy-evaluable patients, confirmed objective response rate was 24% (95% confidence interval, 16, 33), including 10 complete and 15 partial responses. Median duration of response was not reached. Among 25 responders, 17/25 (68%) had ongoing responses. Median progression-free survival and overall survival times were 2.1 and 9.8 mo, respectively. The most common treatment-related adverse events were anemia (27%) and pyrexia (19%). Anemia (7%) and hyponatremia (5%) were the only grade 3-4 treatment-related adverse events and occurred in ≥ 5% of patients. Three investigator-assessed deaths were considered to be possibly related to study treatment (hepatic failure, n = 2; respiratory arrest, n = 1). Tislelizumab demonstrated meaningful clinical benefits in patients with previously treated locally advanced or metastatic PD-L1-positive urothelial carcinoma and had a manageable safety profile.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAsian PeopleCarcinoma, Transitional CellFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalProgression-Free SurvivalUrologic NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicaltislelizumabAsian populationimmunotherapyprogramed death protein-1tislelizumaburothelial carcinoma

Identifiers

PMID33047430
PMCPMC7780053
OpenAlexW3092442011

What OpenQuestion holds

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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.