Evidence map›Paper›PMID 41074192›Full record

ArticleTrials2025

Updated protocol of the POINT trial: a multicenter randomized controlled trial investigating effects of preoperative enteral immunonutrition for esophageal cancer patients treated with neoadjuvant chemoradiotherapy.

Yumeng Cheng, Yuqin Cao, Shengguang Zhao, Qianwen Jin, Jian Li, Chengqiang Li, Yajie Zhang, Weiyu Shen, Jinxian He, Mingsong Wang and 9 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04513418 (Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy), which is not on this map. Not yet cited in PubMed.

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

NCT04513418 phase3active not recruitingnot on this map

Effects of Preoperative Enteral Immunonutrition for Esophageal Cancer Patients Given Neoadjuvant Chemoradiotherapy

TypeinterventionalSponsorHecheng Li M.D., Ph.DRan2020 to 2028Enrolled244ConditionsEsophageal NeoplasmsArmsPreoperative immunonutrition
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

19 authors.

Yumeng Cheng *Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Yuqin Cao *Department of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Shengguang ZhaoDepartment of Radiotherapy, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Qianwen JinDepartment of Clinical Nutrition, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Jian LiClinical Research Center, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Chengqiang LiDepartment of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Yajie ZhangDepartment of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Weiyu ShenDepartment of Thoracic Surgery, the Affiliated Lihuili Hospital, Ningbo University, Ningbo, 315048, China.
Jinxian HeDepartment of Thoracic Surgery, the Affiliated Lihuili Hospital, Ningbo University, Ningbo, 315048, China.
Mingsong WangDepartment of Thoracic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, China.
Guangyu JiDepartment of Thoracic Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200011, China.
Zhigang LiDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.
Yi HeDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200030, China.
Qixun ChenDepartment of Thoracic Oncological Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
Weitian WeiDepartment of Thoracic Oncological Surgery, Cancer Hospital of University of Chinese Academy of Sciences, Zhejiang Cancer Hospital, Hangzhou, 310022, China.
Lijie TanDepartment of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
Hao WangDepartment of Thoracic Surgery, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
Yongmei ShiDepartment of Clinical Nutrition, Ruijn Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. sym10659@rjh.com.cn.
Hecheng LiDepartment of Thoracic Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China. lihecheng2000@hotmail.com.ORCID http://orcid.org/0000-0001-8069-6033

Funding

Interdisciplinary Program of Shanghai Jiao Tong University YG2023ZD04National Key Research and Development Program of China 2021YFC2500900National Natural Science Foundation of China 82072557National Natural Science Foundation of China 82372855National Research Center for Translational Medicine(Shanghai) NRCTM(SH)-2025-12Novel Interdisciplinary Research Project from Shanghai Municipal Health Commission 2022JC023Shanghai Municipal Education Commission - Gaofeng Clinical Medicine Grant 20172005
6 · The paper itself

Abstract

backgroundThe Preoperative Immunonutrition Therapy (POINT) trial compares immunonutrition supplements with a regular diet for surgically resectable esophageal patients during neoadjuvant chemoradiotherapy. The last patient is expected to be included by the end of 2025. The purpose of this update is to present all amendments to the POINT trial protocol as approved by the Ethics Committee of Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital.

designThe initial protocol of the POINT trial has been previously published ( https://doi.org/10.1186/s12885-022-09721-y ). In this ongoing, multicenter, open-labeled, randomized controlled trial, patients are randomly assigned to nutrition therapy group or control group with a 2:1 ratio. Patients in the nutrition therapy group received immune-enhanced enteral nutritional emulsion during the neoadjuvant chemoradiotherapy. Both groups receive neoadjuvant chemoradiotherapy with concurrent radiotherapy followed by minimally invasive esophagectomy. The primary outcome is the rate of nutrition and immune-related complications after surgery. UPDATE: Amendments to the participants include the addition of exclusion criteria and the specification of written informed consent. Amendments to the intervention include an extended window period from neoadjuvant chemoradiotherapy to surgery. Amendments to the outcome include two additional exploratory endpoints, which are minimal residual disease and differences in the distribution of gut microbiota and metabolomics before and after neoadjuvant chemoradiotherapy. An independent assessment committee has been established to perform ongoing safety surveillance outcome evaluation.

conclusionThese amendments do not affect the overall outcomes of the trial compared to the original protocol. The last patient is expected to be included by the end of 2025.

Indexed as

Chemoradiotherapy, AdjuvantEnteral NutritionEsophageal NeoplasmsEsophagectomyImmunonutrition DietNeoadjuvant TherapyPreoperative CareChinaHumansMulticenter Studies as TopicNutritional StatusRandomized Controlled Trials as TopicTreatment OutcomeEsophageal cancerNeoadjuvant chemoradiotherapyPreoperative enteral immunonutritionUpdated protocol

Identifiers

PMID41074192
PMCPMC12512499

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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.