Evidence map›Paper›PMID 38262639›Full record

ArticleBMJ open2024

Bladder sparing by short-course radiotherapy combined with toripalimab in high-risk/extremely high-risk non-muscle invasive bladder cancer (HOPE-04): study protocol for a single-arm, prospective, phase II trial.

Feng Wen, Tianhai Lin, Peng Zhang, Hao Zeng, Qiang Wei, Yali Shen

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 25% 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.

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

3 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
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

6 authors at 1 institution in 1 country.

Feng WenAbdominal Oncology Ward, Division of Radiation Oncology, Cancer Center, West China Hospital Sichuan University, Chengdu, Sichuan, China.
Tianhai LinDepartment of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China.
Peng ZhangDepartment of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China.
Hao ZengDepartment of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China.
Qiang WeiDepartment of Urology, Institute of Urology, West China Hospital Sichuan University, Chengdu, China.ORCID 0000-0003-3750-3042
Yali ShenAbdominal Oncology Ward, Division of Radiation Oncology, Cancer Center, West China Hospital Sichuan University, Chengdu, Sichuan, China sylprecious123@163.com.ORCID 0000-0001-6416-9516
Sichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRadical cystectomy remains the standard treatment for intravesical Bacille Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC) because potential bladder-preserving therapies are not well established. Combination of radiotherapy with programmed death-1 (PD-1) antibody may offer an optional bladder preservation treatment for high-risk/extremely high risk NMIBC. Hence, the current study aims to investigate the safety and efficacy of short-course radiotherapy (5×5 Gy) and toripalimab (PD-1 antibody) as a novel bladder sparing treatment in this population. METHODS AND ANALYSIS: HOPE-04 is an open-label, single-arm, phase II study, designed to evaluate the safety and efficacy of short-course radiotherapy and toripalimab in patients with high-risk/extremely high risk NMIBC. Fifty-five patients with pathological and imaging diagnosed NMIBC with or without BCG treatment will be recruited. Radiotherapy of 5×5 Gy will be given to the whole bladder followed by a focal tumour bed boost and concomitant administration of toripalimab of 240 mg intravenous infusion every 21 days for 12 cycles (about 1 year). The primary endpoints are disease-free survival and safety. The secondary endpoint is overall survival. Additional indicators include implementation rate of salvage surgery and quality of life. ETHICS AND DISSEMINATION: This trial has been approved by the Ethics Committee of West China Hospital, Sichuan University. Trial findings will be disseminated via peer reviewed journals and conference presentations. TRIAL REGISTRATION NUMBER: Chinese Ethics Committee of Registering Clinical Trials (ChiCTR2200059970).

Indexed as

Non-Muscle Invasive Bladder NeoplasmsUrinary Bladder NeoplasmsAntibodies, Monoclonal, HumanizedBCG VaccineClinical Trials, Phase II as TopicHumansProgrammed Cell Death 1 ReceptorProspective StudiesQuality of LifeUrinary BladderAntibodies, Monoclonal, HumanizedBCG VaccineProgrammed Cell Death 1 ReceptortoripalimabImmunologyRADIOTHERAPYUrological tumours

Identifiers

PMID38262639
PMCPMC10806730
OpenAlexW4391146250

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.