Evidence map›Paper›PMID 35165274›Full record

Trial reportNature communications2022

Clinical and biomarker analyses of sintilimab versus chemotherapy as second-line therapy for advanced or metastatic esophageal squamous cell carcinoma: a randomized, open-label phase 2 study (ORIENT-2).

Jianming Xu, Yi Li, Qingxia Fan, Yongqian Shu, Lei Yang, Tongjian Cui, Kangsheng Gu, Min Tao, Xiuwen Wang, Chengxu Cui and 26 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03116152 (Efficacy and Safety Evaluation of IBI308 Versus Paclitaxel/Irinotecan in Patients With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment), which is not on this map. Cited by 95 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 18 pooled it
31.4field-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.

NCT03116152 phase2completednot on this map

Efficacy and Safety Evaluation of IBI308 Versus Paclitaxel/Irinotecan in Patients With Advanced/Metastatic Esophageal Squamous Cell Carcinoma After Failure of First-line Treatment: a Randomized, Open-label, Multicenter, Phase 2 Study (ORIENT-2)

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2017 to 2019Enrolled190ConditionsEsophageal Squamous Cell CarcinomaArmsIBI308, paclitaxel/ irinotecan
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 18 syntheses or guidelines pooled it, 149 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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35 more citing papers are in PubMed but not listed here.

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

36 authors at 20 institutions in 1 country.

Jianming Xu *Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. jmxu2003@yahoo.com.ORCID http://orcid.org/0000-0003-4467-6021
Yi Li *Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.
Qingxia FanDepartment of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
Yongqian ShuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Lei YangDepartment of Radiotherapy, Nantong Tumor Hospital, Nantong, China.
Tongjian CuiDepartment of Medical Oncology, Fujian Provincial Hospital, Fuzhou, China.
Kangsheng GuDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China.
Min TaoDepartment of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China.
Xiuwen WangDepartment of Chemotherapy, Qilu Hospital of Shandong University, Jinan, China.
Chengxu CuiDepartment of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Nong XuDepartment of Medical Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.
Juxiang XiaoDepartment of Medical Oncology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
Quanli GaoDepartment of Immunotherapy, Henan Cancer Hospital, Zhengzhou, China.
Yunpeng LiuDepartment of Oncology, The First Hospital of China Medical University, Shenyang, China.
Tao ZhangCancer Center, Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Yuxian BaiDepartment of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Wei LiCancer Center, The First Hospital of Jilin University, Changchun, China.
Yiping ZhangDepartment of Thoracic Oncology, Zhejiang Cancer Hospital, Hangzhou, China.
Guanghai DaiDepartment of Oncology, Chinese People's Liberation Army General Hospital, Beijing, China.
Dong MaDepartment of Gastrointestinal Oncology, Guangdong Provincial People's Hospital, Guangzhou, China.
Jingdong ZhangDepartment of Gastroenterology, Liaoning Cancer Hospital, Shenyang, China.
Chunmei BaiDepartment of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Yunchao HuangDepartment of Thoracic Surgery I, Yunnan Cancer Hospital, Kunming, China.
Wangjun LiaoDepartment of Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, China.ORCID http://orcid.org/0000-0002-1364-8442
Lin WuDepartmentof Thoracic Medical Oncology, Hunan Cancer Hospital, Changsha, China.
Xi ChenDepartment of Oncology, No. 900 Hospital of The Joint Logistic Support Force, Fuzhou, China.
Yan YangDepartment of Gastrointestinal Oncology, Gansu Provincial Cancer Hospital, Lanzhou, China.
Junye WangDepartment of Oncology, Affiliated Hospital of Jining Medical University, Jining, China.
Shoujian JiDepartment of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China.
Hui ZhouInnovent Biologics, Inc., Suzhou, China.
Yan WangInnovent Biologics, Inc., Suzhou, China.
Zhuo MaInnovent Biologics, Inc., Suzhou, China.
Yanqi WangInnovent Biologics, Inc., Suzhou, China.
Bo PengInnovent Biologics, Inc., Suzhou, China.
Jiya SunInnovent Biologics, Inc., Suzhou, China.
Christoph MancaoInnovent Biologics, Inc., Suzhou, China.
Chinese PLA General Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNAffiliated Hospital of Jining Medical University · CNAnhui Medical University · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNFirst Affiliated Hospital of Zhengzhou University · CNFirst Affiliated Hospital Zhejiang University · CNFirst Hospital of China Medical University · CNFujian Provincial Hospital · CNGansu Provincial Hospital · CNGuangdong Provincial People's Hospital · CNHarbin Medical University · CNHenan Cancer Hospital · CNHunan Cancer Hospital · CNJiangsu Province Hospital · CNJilin University · CNLiaoning Cancer Hospital & Institute · CNNanfang Hospital · CNNantong Tumor Hospital · CNPeople's Liberation Army No. 150 Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This randomized, open-label, multi-center phase 2 study (NCT03116152) assessed sintilimab, a PD-1 inhibitor, versus chemotherapy in patients with esophageal squamous cell carcinoma after first-line chemotherapy. The primary endpoint was overall survival (OS), while exploratory endpoint was the association of biomarkers with efficacy. The median OS in the sintilimab group was significantly improved compared with the chemotherapy group (median OS 7.2 vs.6.2 months; P = 0.032; HR = 0.70; 95% CI, 0.50-0.97). Incidence of treatment-related adverse events of grade 3-5 was lower with sintilimab than with chemotherapy (20.2 vs. 39.1%). Patients with high T-cell receptor (TCR) clonality and low molecular tumor burden index (mTBI) showed the longest median OS (15.0 months). Patients with NLR < 3 at 6 weeks post-treatment had a significantly prolonged median OS (16.6 months) compared with NLR ≥ 3. The results demonstrate a significant improvement in OS of sintilimab compared to chemotherapy as second-line treatment for advanced or metastatic ESCC.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaFemaleHumansImmune Checkpoint InhibitorsIrinotecanMaleMiddle AgedPaclitaxelProgrammed Cell Death 1 ReceptorProgression-Free SurvivalReceptors, Antigen, T-CellAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorImmune Checkpoint InhibitorsIrinotecanPaclitaxelPDCD1 protein, humanProgrammed Cell Death 1 ReceptorReceptors, Antigen, T-Cellsintilimab

Identifiers

PMID35165274
PMCPMC8844279
OpenAlexW4213300728

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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.