Evidence map›Paper›PMID 41056950›Full record

Trial reportCell reports. Medicine2025

Sintilimab plus chemotherapy for first-line treatment of advanced pulmonary lymphoepithelioma-like carcinoma: Phase 2 trial.

Xinqing Lin, Haiyi Deng, Nianxin Fang, Likun Chen, Rui Chen, Xiaohong Xie, Zhanhong Xie, Jiexia Zhang, Ming Liu, Laiyu Liu and 10 more

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

Trial report in Cell reports. Medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04312204 (Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma（LELC）), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT04312204 phase2unknown statusnot on this map

Exploratory Clinical Trial of Sintilimab Combined With Gemcitabine/Carboplatin Regimen in the Treatment of Advanced Primary Pulmonary Lymphoepithelioma-like Carcinoma（LELC）

TypeinterventionalSponsorZhou ChengzhiRan2020 to 2022Enrolled30ConditionsPrimary Pulmonary Lymphoepithelioma-like Carcinoma, Lung CancerArmsSintilimab combined with Gemcitabine and Carboplatin
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. [Progress in Immunotherapy for Pulmonary Lymphoepithelioma Carcinoma].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2025
    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

20 authors.

Xinqing LinState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Haiyi DengState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Nianxin FangDepartment of Pulmonary and Critical Care Medicine, Dongguan People's Hospital, Dongguan 523000, China.
Likun ChenDepartment of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou 510060, China.
Rui ChenDepartment of Respiratory Medicine, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou 510120, China.
Xiaohong XieState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Zhanhong XieState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Jiexia ZhangState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Ming LiuState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Laiyu LiuDepartment of Respiratory and Critical Care Medicine, Nanfang Hospital, Southern Medical University, Guangzhou 510515, China.
Ni SunState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Fei WangState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Yilin YangState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Xinze LvMedical Marketing Department, Burning Rock Biotech, Guangzhou 510300, China.
Zhou ZhangMedical Marketing Department, Burning Rock Biotech, Guangzhou 510300, China.
Shangli CaiMedical Marketing Department, Burning Rock Biotech, Guangzhou 510300, China.
Ting HouMedical Marketing Department, Burning Rock Biotech, Guangzhou 510300, China.
Shiyue LiState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China.
Jianxing HeDepartment of Thoracic Oncology and Surgery, China State Key Laboratory of Respiratory Disease and National Clinical Research Center for Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China. Electronic address: drjianxing.he@gmail.com.
Chengzhi ZhouState Key Laboratory of Respiratory Diseases, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Pulmonary and Critical Care Medicine, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou 510120, China. Electronic address: doctorzcz@163.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Pulmonary lymphoepithelioma-like carcinoma (PLELC) is a unique non-small cell lung cancer associated with Epstein-Barr virus (EBV), lacking a standard treatment. This phase 2 study evaluates sintilimab plus gemcitabine and carboplatin (4 cycles), followed by sintilimab maintenance in 30 untreated patients with locally advanced or metastatic PLELC. At a median follow-up of 42.4 months, the objective response rate is 73.3% and disease control is 100.0%. The median progression-free survival (PFS) is 13.5 months (95% confidence interval [CI], 12.2-24.5), and median overall survival is 46.9 months (95% CI, 29.5-not reached [NR]). Grade ≥3 treatment-related adverse events occurred in 70.0% of patients, mainly neutropenia (46.7%). Higher T cell-inflamed gene-expression profile score is associated with longer PFS (p = 0.003). Plasma EBV-DNA levels decrease with treatment response and increase with disease progression. Sintilimab plus chemotherapy shows promising efficacy with manageable safety as first-line treatment for advanced PLELC. This study was registered at ClinicalTrials.gov (NCT04312204).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungLung NeoplasmsAdultAgedCarboplatinDeoxycytidineEpstein-Barr Virus InfectionsFemaleGemcitabineHerpesvirus 4, HumanHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedCarboplatinDeoxycytidineGemcitabinesintilimabEpstein-Barr virusPD-1 inhibitorpulmonary lymphoepithelioma-like carcinomasintilimabT cell-inflamed gene-expression profile

Identifiers

PMID41056950
PMCPMC12629799

What OpenQuestion holds

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LicenceCC BY-NC
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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.