Evidence map›Paper›PMID 37864049›Full record

Trial reportBritish journal of cancer2023

Nimotuzumab plus concurrent chemo-radiotherapy in unresectable locally advanced oesophageal squamous cell carcinoma (ESCC): interim analysis from a Phase 3 clinical trial.

Xue Meng, Anping Zheng, Jun Wang, Xiaoyuan Wu, Guang Li, Jun Zhu, Hu Ma, Xiaodong Zhu, Anhui Shi, Chunhua Dai and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02409186 (A Randomized, Controlled, Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT02409186 phase3unknown statusnot on this map

A Randomized, Controlled, Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma

TypeinterventionalSponsorShandong Cancer Hospital and InstituteRan2015 to 2021Enrolled200ConditionsProsthesis SurvivalArmsNimotuzumab, radiotherapy, chemoradiotherapy Paclitaxel, chemoradiotherapy Cisplatin, placebo
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

  1. Trial
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  7. Esophageal cancer: from pathogenesis to precision therapies.Signal transduction and targeted therapy · 2026
    Review
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  10. Review
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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

20 authors.

Xue MengDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China.
Anping ZhengDepartment of Radiation Oncology, Anyang Cancer Hospital, Anyang, China.
Jun WangDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Xiaoyuan WuDepartment of Radiation Oncology, Henan Cancer Hospital, Zhengzhou, China.
Guang LiDepartment of Radiation Oncology, The First Hospital of China Medical University, Shenyang, China.
Jun ZhuDepartment of Radiation Oncology, Jiangsu Cancer Hospital, Nanjing, China.
Hu MaDepartment of Radiation Oncology, Affiliated Hospital of Zunyi Medical College, Zunyi, China.
Xiaodong ZhuDepartment of Radiation Oncology, Guangxi Medical University Cancer Hospital, Nanning, China.
Anhui ShiDepartment of Radiation Oncology, Beijing Cancer Hospital, Beijing, China.
Chunhua DaiDepartment of Radiation Oncology, Affiliated Hospital of Jiangsu University, Zhenjiang, China.
Senxiang YanDepartment of Radiation Oncology, The First Hospital of Zhejiang Province, Hangzhou, China.
Buhai WangDepartment of Oncology, Subei People's Hospital, Yangzhou University, Yangzhou, China.
Zhongyu QuDepartment of Medical Oncology, Henan Provincial Nanyang Central Hospital, Nanyang, China.
Chun HanDepartment of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Xindong SunDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China.
Ming YeDepartment of Radiation Oncology, Renji Hospital Shanghai jiaotong university School of medicine, Shanghai, China.
Ruitai FanDepartment of Radiation Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Niyazi HuerxidanDepartment of Oncology, The First Affiliated Hospital of Xinjiang Medical University, Urumqi, China.
Xiaohong WangDepartment of Radiation Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Jinming YuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China. sdyujinming@126.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis prospectively randomised, double-blinded, placebo-controlled, multicenter Phase 3 clinical trial was conducted to assess the efficacy and safety profile of nimotuzumab (nimo) plus concurrent chemo-radiotherapy (CCRT) in patients with unresectable locally advanced ESCC.

methodsPatients were randomly assigned (1:1) to receive CCRT plus nimotuzumab or placebo. The primary endpoint was overall survival (OS). In addition, interim analysis for short-term response rate was pre-defined.

resultsA total of 201 patients were randomised into two groups. Eighty patients in the nimo group and eighty-two in the placebo group were evaluable. Three to six months after treatment, 26 (32.5%) patients achieved complete response (CR) in the nimo group, and 10 (12.2%) in the placebo group (P = 0.002). The ORR of the nimo group was significantly higher than the placebo group (93.8% vs. 72.0%, P < 0.001). The two groups' grade 3-5 adverse drug reactions were 11.1% vs. 10.9% (P > 0.05).

conclusionsNimotuzumab, in combination with chemo-radiotherapy, increased the CRR and ORR with a good safety profile. The OS is needed to be followed and finally analysed. CLINICAL

trial registrationNCT02409186.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyHumansAntibodies, Monoclonal, Humanizednimotuzumab

Identifiers

PMID37864049
PMCPMC10667212

What OpenQuestion holds

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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.