Evidence map›Paper›PMID 41148490›Full record

ArticleClinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico2026

Intrapleural anti-PD-1 antibody for the treatment of advanced non-small cell lung cancer with malignant pleural effusion: a prospective, single-arm, single-center, phase I trial.

Yuting Cui, Qiuxia Wu, Yue Hao, Guannan Wu, Qinpei Cheng, Xincui Song, Lu Chen, Xin Hua, Yuxin Jiang, Di Cheng and 5 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. 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

15 authors.

Yuting CuiDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Qiuxia WuJinling Clinical Medical College, Nanjing University of Chinese Medicine, Nanjing, 210023, China.
Yue HaoDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Guannan WuDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Qinpei ChengDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Xincui SongDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Lu ChenDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Xin HuaDepartment of Geriatric Medicine, Nanjing Drum Tower Hospital, Nanjing University School of Medicine, Nanjing, 210002, China.
Yuxin JiangSchool of Medicine, Southeast University, Nanjing, 210000, China.
Di ChengDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Suhua ZhuDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Xin LiuDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China.
Yong SongDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China. yong.song@nju.edu.cn.
Tangfeng LvDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China. bairoushui@163.com.
Ping ZhanDepartment of Respiratory and Critical Care Medicine, Jinling Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210002, China. zhanping207@163.com.ORCID http://orcid.org/0009-0001-3030-2662

Funding

National Natural Science Foundation of China 82172728National Natural Science Foundation of China 82370096Science and Technology Innovation Research Project of Jinling Hospital 2023JCYJZD080Science and Technology Innovation Research Project of Jinling Hospital 22LCYY-LH3
6 · The paper itself

Abstract

backgroundThe presence of malignant pleural effusion (MPE) remains a challenge in clinical treatment. This study aimed to evaluate the safety and efficacy of intrapleural administration of anti-programmed cell death 1 (PD-1) antibody, specifically targeting patients with advanced non-small cell lung cancer (NSCLC) complicated by MPE.

methodsFrom May 2019 to December 2023, a total of 16 advanced NSCLC patients with MPE were enrolled. Each patient received a single intrapleural dose of 100 mg of sintilimab. The primary outcome was safety, while secondary outcomes included the proportion of participants who achieved successful pleurodesis by day 35 and day 70 post-intervention; median pleural progression-free survival (mPPFS); the objective response rate (ORR) of extra-pleural tumor at both day 35 and day 70.

resultsAmong the 16 patients, the proportion of participants with successful pleurodesis at day 35 was 75.0% (12/16), which decreased to 56.3% (9/16) by day 70. The mPPFS was 10.4 weeks (95% CI 7.6-13.3 weeks). The ORR of extrapleural tumors at day 35 was 12.5%, with 12.5% (2/16) of patients achieving partial remission (PR), 81.3% (13/16) maintaining stable disease (SD), and 6.3% (1/16) experiencing disease progression (PD). As for safety, the treatment-related adverse events (TRAEs) were well-tolerated. However, 93.8% (15/16) patients experienced treatment-emergent adverse events (TEAEs). The incidence rate of grade 3 TEAEs was 25.0% (4/16), and no grade 4 TEAEs occurred in any patients.

conclusionsIntrapleural injection of anti-PD-1 antibody demonstrates promising efficacy and a tolerable safety profile as a novel therapeutic strategy for managing MPE in advanced NSCLC.

trial registrationThis trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR2400087743).

Indexed as

Antibodies, Monoclonal, HumanizedCarcinoma, Non-Small-Cell LungImmune Checkpoint InhibitorsLung NeoplasmsPleural Effusion, MalignantProgrammed Cell Death 1 ReceptorAdultAgedFemaleHumansMaleMiddle AgedPleurodesisProspective StudiesAntibodies, Monoclonal, HumanizedImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 ReceptorsintilimabAnti-PD-1 antibodyIntrapleural injectionMalignant pleural effusionNon-small cell lung cancerSafety

Identifiers

PMID41148490

What OpenQuestion holds

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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.