Evidence map›Paper›PMID 40413023›Full record

Trial reportJournal for immunotherapy of cancer2025

Tislelizumab as adjuvant therapy following endoscopic surgery for resectable recurrent nasopharyngeal carcinoma: a randomized clinical trial.

Wanpeng Li, Tian Wang, Haoyuan Xu, Quan Liu, Huankang Zhang, Yufei Yang, Xicai Sun, Huapeng Yu, Yurong Gu, Houyong Li and 2 more

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

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05092217 (Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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.

NCT05092217 phase2unknown statusnot on this map

Tirelizumab Plus Surgery vs Surgery Alone for Recurrent Nasopharyngeal Carcinoma：a Prospecitve, Parallel, Phase II, Randomized Clinical Trial

TypeinterventionalSponsorEye & ENT Hospital of Fudan UniversityRan2021 to 2024Enrolled80ConditionsNasopharyngeal CarcinomaArmsTirelizumab, salvage surgery
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  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

12 authors.

Wanpeng LiENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Tian WangDepartment of Radiation Oncology, Eye Ear Nose and Throat Hospital of Fudan University, Shanghai, China.
Haoyuan XuENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Quan LiuENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Huankang ZhangENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Yufei YangENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Xicai SunENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Huapeng YuENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Yurong GuENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Houyong LiENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China.
Hao DingDepartment of Radiation Oncology, Eye Ear Nose and Throat Hospital of Fudan University, Shanghai, China wangdehuient@sina.com eentding@163.com.
Dehui WangENT Institute and Department of Otorhinolaryngology, Eye and ENT Hospital, Fudan University, Shanghai, China wangdehuient@sina.com eentding@163.com.ORCID http://orcid.org/0000-0003-0346-3193

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEndoscopic surgery has become the first-line treatment for surgically resectable recurrent nasopharyngeal carcinoma (rNPC), but it is associated with a high risk of postoperative tumor progression. Currently, there is a lack of effective and well-tolerated adjuvant treatment regimens. Thus, the primary objective was to investigate the efficacy and safety of tislelizumab as adjuvant therapy with endoscopic surgery for the treatment of patients with rNPC.

methodsThis was a single-center, open-label, randomized, controlled, phase 2 trial between November 23, 2021, and May 8, 2024. Eligible patients included those with complete tumor disappearance as indicated by postoperative imaging, histopathologically diagnosed with undifferentiated or differentiated non-keratinizing rNPC. Patients with rNPC were randomized to receive endoscopic surgery alone or adjuvant tislelizumab treatment 2-6 weeks after endoscopic surgery. Tislelizumab was administered as a 200 mg intravenous infusion every 3 weeks until disease progression, death, unacceptable toxicity, withdrawal of consent, investigator's decision, or 1 year. The primary endpoint was progression-free survival (PFS) at 1 year, and secondary endpoints included 1-year progression-free interval (PFI), 1-year overall survival (OS), and safety.

resultsThe trial is ongoing. 42 patients were enrolled at a median follow-up of 18 months (IQR 10-27), the 1-year PFS was significantly higher in the tislelizumab group (94%, 95% CI: 83% to 100%) than in the endoscopic surgery alone group (57%, 95% CI: 38% to 85%). The 1-year PFI was also higher in the tislelizumab group (100%, 95% CI: 100% to 100%) than in the endoscopic surgery alone group (60%, 95% CI: 40% to 89%). No significant difference in the 1-year OS was observed at the data cut-off. Grade ≥3 immune-related adverse events (irAEs) occurred in 9% of tislelizumab recipients, and all of these events were elevated blood creatine phosphokinase levels. Additionally, the most common irAEs in this group were hypothyroidism, affecting 27%, and pruritus, observed in 9%.

conclusionsTislelizumab as adjuvant therapy significantly enhanced PFS and PFI, with a favorable safety profile. Longer follow-up is necessary to determine whether this regimen can be considered as the standard of care for patients with resectable rNPC following endoscopic surgery. TRIAL REGISTRATION NUMBER: NCT05092217.

Indexed as

Antibodies, Monoclonal, HumanizedEndoscopyNasopharyngeal CarcinomaNasopharyngeal NeoplasmsNeoplasm Recurrence, LocalAdultAgedChemotherapy, AdjuvantFemaleHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedtislelizumabAdjuvantEndoscopicHead and Neck CancerImmunotherapySURGERY

Identifiers

PMID40413023
PMCPMC12104945

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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.