Evidence map›Paper›PMID 35440464›Full record

Trial reportBMJ (Clinical research ed.)2022

Sintilimab versus placebo in combination with chemotherapy as first line treatment for locally advanced or metastatic oesophageal squamous cell carcinoma (ORIENT-15): multicentre, randomised, double blind, phase 3 trial.

Zhihao Lu, Junye Wang, Yongqian Shu, Lianke Liu, Li Kong, Lei Yang, Buhai Wang, Guogui Sun, Yinghua Ji, Guochun Cao and 21 more

5 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMJ (Clinical research ed.), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 5 registered trials, which are not on this map. Cited by 307 papers, 19 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
307citing papers in PubMed, 19 pooled it
93.7field-weighted citation impact, top 1% 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.

NCT03748134 phase3completednot on this map

A Multicenter, Double-Blind, Randomized Phase 3 Clinical Trial Evaluating the Efficacy and Safety of Sintilimab vs. Placebo, in Combination With Chemotherapy, for First-Line Treatment of Unresectable, Locally Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma (ORIENT-15)

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2018 to 2023Enrolled746ConditionsEsophageal Squamous Cell CarcinomaArmsSintilimab, Cisplatin, Paclitaxel, Fluorouracil, Placebo
NCT05978193 phase2recruitingnot on this mapstarted 2023, after this paper: background citation

First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)

TypeinterventionalSponsorShanghai Chest HospitalRan2023 to 2028Enrolled100ConditionsEsophageal Squamous Cell Carcinoma, Esophageal Cancer, Metastatic Esophageal Squamous Cell CarcinomaArmsLDRT+CFRT, Immunotherapy, Chemotherapy
NCT06863831 naenrolling by invitationnot on this mapstarted 2024, after this paper: background citation

Yishen Qutong Granules vs. Simulant Combined With Neoadjuvant Chemoradiotherapy or Chemoimmunotherapy in the Treatment of Locally Advanced Esophageal Cancer: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial Protocol

TypeinterventionalSponsorCancer Institute and Hospital, Chinese Academy of Medical SciencesRan2024 to 2027Enrolled536ConditionsEsophageal Squamous Cell Carcinoma (ESCC)ArmsYishen Qutong Granules, Yishen Qutong Simulant Granules
NCT06960889 active not recruitingnot on this mapstarted 2025, after this paper: background citation

A Retrospective Clinical Study Exploring Prognostic Factors in Esophageal Cancer Patients

TypeobservationalSponsorNanfang Hospital, Southern Medical UniversityRan2025 to 2027Enrolled500ConditionsEsophageal Cancer (EsC)Armsradiotherapy, Immunotherapy, surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
NCT07688291 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Prospective, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of PD-1/IL-2α-bias Bispecific Antibody Fusion Protein Monotherapy in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Failure of Prior Immune Checkpoint Inhibitor Plus Platinum-Based Chemotherapy

TypeinterventionalSponsorBeijing GoBroad HospitalRan2026 to 2029Enrolled40ConditionsEsophageal Squamous Carcinoma CellArmsPD-1/IL-2α-bias bispecific antibody fusion protein
3 · Its place in the literature

Who cites it

307 citing papers in PubMed, 19 syntheses or guidelines pooled it, 456 citations in OpenAlex.

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  2. Neutrophil-to-lymphocyte ratio in unresectable or metastatic esophageal squamous cell carcinoma: a systematic review, meta-analysis and meta-regression.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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247 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

31 authors at 20 institutions in 2 countries.

Zhihao LuDepartment of Gastrointestinal Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Junye WangDepartment of Oncology, The Affiliated Hospital of Jining Medical College, Jining, China.
Yongqian ShuDepartment of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Lianke LiuDepartment of Medical Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Li KongSpecial Needs Ward, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Lei YangDepartment of Medical Oncology, Nantong Tumour Hospital, Nantong, China.
Buhai WangDepartment of Medical Oncology, Northern Jiangsu People's Hospital, Affiliated Hospital to Yangzhou University, Yangzhou, China.
Guogui SunDepartment of Radiotherapy and Chemotherapy, Tangshan People's Hospital, Tangshan, China.
Yinghua JiDepartment of Medical Oncology, The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, China.
Guochun CaoDepartment of Oncology, Jiangsu Cancer Hospital, Nanjing Medical University, Nanjing, China.
Hu LiuDepartment of Medical Oncology, Anhui Provincial Cancer Hospital, University of Science and Technology of China, Hefei, China.
Tongjian CuiDepartment of Oncology, Fujian Provincial Hospital, Fuzhou, China.
Na LiDepartment of Medical Oncology, Suining Central Hospital, Suining, China.
Wensheng QiuDepartment of Medical Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.
Gaofeng LiDepartment of Thoracic Surgery Ward 2, Yunnan Cancer Hospital, Kunming, China.
Xinfang HouDepartment of Medical Oncology, Henan Tumour Hospital, Zhengzhou, China.
Hui LuoDepartment of Thoracic Tumour Radiotherapy Ward 2, Jiangxi Cancer Hospital, Nanchang, China.
Liying XueDepartment of Medical Oncology, Inner Mongolia People's Hospital, Hohhot, China.
Yanqiao ZhangDepartment of Digestive Oncology Ward 2, Harbin Medical University Cancer Hospital, Harbin, China.
Wenbin YueDepartment of Medical Oncology, Puyang Oilfield General Hospital, Puyang, China.
Zheng LiuDepartment of Medical Oncology Three, Handan Central Hospital, Handan, China.
Xiuwen WangDepartment of Oncology, Qilu Hospital of Shandong University, Jinan, China.
Shegan GaoOncology Department, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China.
Yueyin PanDepartment of Tumour Chemotherapy, Anhui Provincial Hospital, Hefei, China.
Marie-Pierre GalaisDepartment of Medical Oncology, Centre François Baclesse, Caen, France.
Aziz ZaananDepartment of Gastroenterology and Digestive Oncology, Hôpital Européen Georges Pompidou, Paris, France.
Zhuo MaMedical Science and Strategy Oncology, Innovent Biologics, China.
Haoyu LiDepartment of Statistics, Innovent Biologics, China.
Yan WangMedical Science and Strategy Oncology, Innovent Biologics, China.
Lin ShenKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China linshenpku@163.com.ORCID 0000-0003-1134-2922
ORIENT-15 study group
Jiangsu Province Hospital · CNPeking University · CNAffiliated Hospital of Jining Medical University · CNAnhui Provincial Hospital · CNCentre François Baclesse · FRDaqing Oilfield General Hospital · CNFirst Affiliated Hospital of Henan University of Science and Technology · CNFirst Affiliated Hospital of Xinxiang Medical University · CNFujian Provincial Hospital · CNHandan College · CNHarbin Medical University · CNHenan Cancer Hospital · CNHôpital Européen Georges-Pompidou · FRInner Mongolia People's Hospital · CNJiangsu Cancer Hospital · CNJiangxi Provincial Cancer Hospital · CNNantong Tumor Hospital · CNNorthern Jiangsu People's Hospital · CNQilu Hospital of Shandong University · CNQingdao University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate sintilimab versus placebo in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) as first line treatment of unresectable locally advanced, recurrent, or metastatic oesophageal squamous cell carcinoma.

designMulticentre, randomised, double blind, phase 3 trial.

setting66 sites in China and 13 sites outside of China between 14 December 2018 and 9 April 2021.

participants659 adults (aged ≥18 years) with advanced or metastatic oesophageal squamous cell carcinoma who had not received systemic treatment.

interventionParticipants were randomised 1:1 to receive sintilimab or placebo (3 mg/kg in patients weighing <60 kg or 200 mg in patients weighing ≥60 kg) in combination with cisplatin 75 mg/m

main outcome measuresOverall survival in all patients and in patients with combined positive scores of ≥10 for expression of programmed cell death ligand 1.

results659 patients were randomly assigned to sintilimab (n=327) or placebo (n=332) with chemotherapy. 616 of 659 patients (93%) received sintilimab or placebo in combination with cisplatin plus paclitaxel and 43 of 659 patients (7%) received sintilimab or placebo in combination with cisplatin plus 5-fluorouracil. At the interim analysis, sintilimab with chemotherapy showed better overall survival compared with placebo and chemotherapy in all patients (median 16.7

conclusionsCompared with placebo, sintilimab in combination with cisplatin plus paclitaxel showed significant benefits in overall survival and progression free survival as first line treatment in patients with advanced or metastatic oesophageal squamous cell carcinoma. Similar benefits of sintilimab with cisplatin plus 5-fluorouracil seem promising.

trial registrationClinicalTrials.gov NCT03748134.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdolescentAdultCisplatinDouble-Blind MethodFluorouracilHumansPaclitaxelAntibodies, Monoclonal, HumanizedCisplatinFluorouracilPaclitaxelsintilimab

Identifiers

PMID35440464
PMCPMC9016493
OpenAlexW4224260137

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.