Evidence map›Paper›PMID 39465257›Full record

Trial reportSignal transduction and targeted therapy2024

Perioperative sintilimab and neoadjuvant anlotinib plus chemotherapy for resectable non-small-cell lung cancer: a multicentre, open-label, single-arm, phase 2 trial (TD-NeoFOUR trial).

Hongtao Duan, Changjian Shao, Zhilin Luo, Tianhu Wang, Liping Tong, Honggang Liu, Xin Yao, Jie Lei, Jinbo Zhao, Yuan Gao and 2 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

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

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

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  9. Higher proximity of PD-L1Translational lung cancer research · 2026
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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.

Hongtao Duan *Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.
Changjian Shao *Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.ORCID 0000-0002-2487-9692
Zhilin Luo *Department of Thoracic Surgery, Third Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Tianhu Wang *Department of Thoracic Surgery, Third Affiliated Hospital, Chongqing Medical University, Chongqing, China.
Liping Tong *Department of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.
Honggang LiuDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.
Xin YaoDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.
Jie LeiDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.
Jinbo ZhaoDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China.
Yuan GaoState Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Biotechnology Center, School of Pharmacy, Air Force Medical University, No. 169, Changle West Road, Xi'an, Shaanxi, China. gaoyuan321@fmmu.edu.cn.
Tao JiangDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China. jiangtaochest@163.com.
Xiaolong YanDepartment of Thoracic Surgery, Tangdu Hospital, Air Force Medical University, No. 1, Xinsi Road, Xi'an, Shaanxi, China. yanxiaolong@fmmu.edu.cn.ORCID 0000-0003-2419-9707

Funding

National Natural Science Foundation of China (National Science Foundation of China) 82173252
6 · The paper itself

Abstract

This open-label, single-arm, phase 2 trial evaluated the efficacy and safety of neoadjuvant sintilimab combined with anlotinib and chemotherapy, followed by adjuvant sintilimab, for resectable NSCLC. Forty-five patients received anlotinib (10 mg, QD, PO, days 1-14), sintilimab (200 mg, day 1), and platinum-based chemotherapy of each three-week cycle for 3 cycles, followed by surgery within 4-6 weeks. Adjuvant sintilimab (200 mg) was administered every 3 weeks. The primary endpoint was achieving a pathological complete response (pCR). From June 10, 2021 through October 10, 2023, 45 patients were enrolled and composed the intention-to-treat population. Twenty-six patients (57.8%) achieved pCR, and 30 (66.7%) achieved major pathological response (MPR). Forty-one patients underwent surgery. In the per-protocol set (PP set), 63.4% (26/41) achieved pCR, and 73.2% achieved MPR. The median event-free survival was not attained (95% CI, 25.1-NE). During the neoadjuvant treatment phase, grade 3 or 4 treatment-related adverse events were observed in 25 patients (55.6%), while immune-related adverse events were reported in 7 patients (15.6%). We assessed vascular normalization and infiltration of immune-related cells by detecting the expression of relevant cell markers in NSCLC tissues with mIHC. Significant tumor microenvironment changes were observed in pCR patients, including reduced VEGF

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungIndolesLung NeoplasmsNeoadjuvant TherapyQuinolinesAdultAgedAntibodies, Monoclonal, HumanizedFemaleHumansMaleMiddle AgedanlotinibAntibodies, Monoclonal, HumanizedIndolesQuinolinessintilimab

Identifiers

PMID39465257
PMCPMC11514280

What OpenQuestion holds

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LicenceCC BY
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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.