Evidence map›Paper›PMID 35524205›Full record

Trial reportBMC cancer2022

Three-arm phase II trial comparing camrelizumab plus chemotherapy versus camrelizumab plus chemoradiation versus chemoradiation as preoperative treatment for locally advanced esophageal squamous cell carcinoma (NICE-2 Study).

Yang Yang, Li Zhu, Yan Cheng, Zhichao Liu, Xiaoyue Cai, Jinchen Shao, Ming Zhang, Jun Liu, Yifeng Sun, Yin Li and 7 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
7.0field-weighted citation impact, top 2% of its field
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.

NCT05043688 phase3recruitingnot on this map

Camrelizumab Plus Neoadjuvant Chemotherapy or Chemoradiotherapy Versus Neoadjuvant Chemoradiotherapy Alone for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma (NICE 2): a Multi-center, Randomized Phase II Trial

TypeinterventionalSponsorZhigang LiRan2021 to 2030Enrolled426ConditionsResectable Esophageal Squamous Cell CarcinomaArmsCamrelizumab, radiotherapy
NCT06385730 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Neoadjuvant PD-1 Blockade (Toripalimab) Monotherapy for Elderly Patients With Locally Advanced Resectable Esophageal Squamous Cell Carcinoma: a Phase II Trial

TypeinterventionalSponsorShanghai Chest HospitalRan2024 to 2027Enrolled60ConditionsEsophageal CancerArmsneoadjuvant anti-PD-1, neoadjuvant anti-PD-1 with LDRT
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

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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

17 authors at 8 institutions in 1 country.

Yang YangDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China.
Li ZhuDepartment of Radiology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Yan ChengDepartment of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Zhichao LiuDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China.
Xiaoyue CaiDepartment of Integrative Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Jinchen ShaoDepartment of Pathology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Ming ZhangDepartment of Integrative Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Jun LiuDepartment of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, China.
Yifeng SunDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China.
Yin LiDepartment of Thoracic Surgery, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China.
Jun YiDepartment of Cardiothoracic Surgery, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.
Bentong YuDepartment of Thoracic Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, China.
Hongjing JiangDepartment of Thoracic Surgery, Tianjin Medical University Cancer Hospital, Tianjin, China.
Hezhong ChenDepartment of Thoracic Surgery, Changhai Hospital Affiliated to The Second Military Medical University, Shanghai, China.
Hong YangDepartment of Thoracic Surgery, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Lijie TanDepartment of Thoracic Surgery, Zhongshan Hospital Affiliated to Fudan University, Shanghai, China.
Zhigang LiDepartment of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, 241 West Huaihai Road, Shanghai, 200030, China. zhigang.li@shsmu.edu.cn.ORCID http://orcid.org/0000-0001-5086-5334
Shanghai Jiao Tong University · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFudan University · CNNanchang University · CNNanjing General Hospital of Nanjing Military Command · CNSecond Military Medical University · CNSun Yat-sen University · CNTianjin Medical University Cancer Institute and Hospital · CN

Funding

National Key Scientific Instrument and Equipment Development Projects of China 2021YFC2501005
6 · The paper itself

Abstract

backgroundPreoperative chemoradiotherapy (CRT) with CROSS regimen has been the recommended treatment for locally advanced esophageal squamous cell carcinoma (ESCC). The addition of programmed cell death protein 1 (PD-1) inhibitor to preoperative CRT may further improve oncologic results. Preoperative camrelizumab plus chemotherapy has been demonstrated as a promising treatment modality based on results of the phase II NICE study (ChiCTR1900026240).

methodsThe NICE-2 study is designed as a three-arm, multicenter, prospective, randomized, phase II clinical trial, comparing camrelizumab plus chemotherapy (IO-CT) and camrelizumab plus CRT (IO-CRT) versus CRT as preoperative treatment for locally advanced ESCC. A total of 204 patients will be recruited from 8 Chinese institutions within 1.5 years. The primary endpoint is pathological complete response (pCR) rate and secondary endpoints include event-free survival (EFS), R0 resection rate, and adverse events. DISCUSSION: This is the first prospective randomized controlled trial to explore commonly used neoadjuvant treatments in clinical practice, which will provide high-level evidence of neoadjuvant treatment for patients with locally advanced ESCC. The purpose of this study is to establish the optimal modality of IO-CT, IO-CRT and CRT as preoperative treatment for locally advanced ESCC. The Institution Review Committee approved this study protocol in August 2021 and patient enrollment was started in September 2021.

trial registrationClinicalTrial.gov: NCT05043688 (August 29, 2021). The trial was prospectively registered.

Indexed as

Esophageal NeoplasmsEsophageal Squamous Cell CarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyHumansNeoadjuvant TherapyProspective StudiesAntibodies, Monoclonal, HumanizedcamrelizumabCamrelizumabChemoradiotherapyChemotherapyClinical trialEsophageal cancer

Identifiers

PMID35524205
PMCPMC9074348
OpenAlexW4229046570

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.