Evidence map›Paper›PMID 40826031›Full record

Trial reportBMC cancer2025

Four-year follow-up from the phase 2 study TD-NICE: neoadjuvant treatment of tislelizumab combined with chemotherapy in resectable esophageal squamous cell carcinoma.

Yajie Mao, Zhiyuan Gao, Yichen Sun, Changjian Shao, Hongtao Duan, Xiaolong Yan

Erratum issuedAbstract readClinical Trial, Phase II
In one paragraph

Trial report in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Yajie Mao *Department of Thoracic Surgery, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, China.
Zhiyuan Gao *Department of Thoracic Surgery, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, China.
Yichen SunDepartment of Thoracic Surgery, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, China.
Changjian ShaoDepartment of Thoracic Surgery, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, China.
Hongtao DuanDepartment of Thoracic Surgery, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, China. 646014852@qq.com.
Xiaolong YanDepartment of Thoracic Surgery, Tangdu Hospital, Fourth Military Medical University, 1 Xinsi Road, Xi'an, 710038, China. yanxiaolong@fmmu.edu.cn.

Funding

Shaanxi Science and Technology Co-ordination and Innovation Project of China 2023-cx-td-64
6 · The paper itself

Abstract

backgroundThe efficacy and safety of tislelizumab combined with chemotherapy as neoadjuvant therapy have been presented and evaluated in previously published TD-NICE study. However, the long-term impacts of patients who received tislelizumab plus chemotherapy followed by surgery were not observed in the study.

methodsFrom September 2020 to March 2021, a total of 45 patients were enrolled in the TD-NICE trial. The 4 -year follow-up data of the TD-NICE ITT population were collected by investigators. The primary endpoint was OS, and the secondary endpoint was EFS. Kaplan-Meier method and cox proportional hazards model were used to proceed statistical analysis.

resultsThe median OS and EFS were not reached in all patients. The OS was 82.2% (95%CI:67.6-90.7) at 12 months, 73.3%(95%CI:57.8-83.9) at 24 months, 66.7%(95%CI:50.9-78.4) at 36 months and simulated 66.2% (95%CI:46.5-74.6) at 48 months. There were statistically significant differences between surgery and non-surgery patients(P = 0.046). And patients with R0 resection had a higher improvement in OS than those with R1&R2 resection (P = 0.041). The differences in EFS in surgery and non-surgery group (P = 0.046) as well as in R0 resection and R1&R2 resection group (P = 0.045) were significant, respectively. DISCUSSION: Our study identified that chemoimmunotherapy plus surgery could improve overall survival in resectable ESCC, and patients had significant benefits from surgery and R0 tumor resection.

trial registrationTD-NICE study was registered in the August 28, 2020, and the registration number was ChiCTR2000037488 (Chinese Clinical Trial Registry (ChiCTR) identifier).

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaNeoadjuvant TherapyAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedAntibodies, Monoclonal, HumanizedtislelizumabEsophageal cancerNeoadjuvant chemoimmunotherapySurvival analysis

Identifiers

PMID40826031
PMCPMC12359864

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.