Evidence map›Paper›PMID 34702811›Full record

Trial reportSignal transduction and targeted therapy2021

Sintilimab for relapsed/refractory extranodal NK/T cell lymphoma: a multicenter, single-arm, phase 2 trial (ORIENT-4).

Rong Tao, Lei Fan, Yongping Song, Yu Hu, Wei Zhang, Yafei Wang, Wei Xu, Jianyong Li

5 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Signal transduction and targeted therapy, 2021. 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 80 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 1 pooled it
10.5field-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.

NCT03228836 phase2completednot on this map

Efficacy and Safety Evaluation of IBI308 in Patients With Relapsed/Refractory Extranodal NK/T Cell Lymphoma, Nasal Type: a Multicenter, Single Arm, Phase 2 Study (ORIENT-4)

TypeinterventionalSponsorInnovent Biologics (Suzhou) Co. Ltd.Ran2017 to 2020Enrolled28ConditionsEffect of DrugsArmsSintilimab
NCT05316246 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Efficacy and Safety of Brentuximab Vedotin in Combination With Tislelizumab for the Treatment of CD30-positive Relapsed/Refractory NK/T-cell Lymphoma

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2022 to 2024Enrolled40ConditionsNK/T Cell Lymphoma NosArmsBrentuximab Vedotin in Combination with Tislelizumab
NCT06966154 phase1 / phase2recruitingnot on this mapstarted 2025, after this paper: background citation

A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of Relapsed/Refractory Natural Killer/T-Cell Lymphoma (NKTCL)

TypeinterventionalSponsorFudan UniversityRan2025 to 2028Enrolled68ConditionsNatural Killer/T-cell Lymphoma, Relapsed or Refractory Lymphoma Including ENKLArmstislezumab, golidocitinib, Selinexor
NCT07502768 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

A Multicenter, Open-Label, Seamless Phase Ib/II Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Zeprumetostat (SHR2554) in Patients With Relapsed or Refractory NK/T-Cell Lymphoma

TypeinterventionalSponsorRong TaoRan2026 to 2028Enrolled107ConditionsExtranodal NK/T-cell Lymphoma, NK/T-cell Lymphoma, Relapsed or Refractory NK/T-Cell LymphomaArmsTislelizumab, Zeprumetostat
NCT07768943 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

A Prospective Multicenter Response-Adapted Treatment Study Based on Early Response Assessment After GELAD Induction Chemotherapy in Early-Stage Extranodal NK/T-Cell Lymphoma

TypeinterventionalSponsorFudan UniversityRan2026 to 2036Enrolled620ConditionsNatural Killer/T-cell LymphomaArmsGemcitabine (GEM), Etoposide Injection, Dexamethasone, pegaspargase, IMRT 50 Gy
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 1 synthesis or guideline pooled it, 90 citations in OpenAlex.

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  19. Molecular pathogenesis and evolving treatment landscape of extranodal NK/T-cell lymphoma.Proceedings of the Japan Academy. Series B, Physical and biological sciences · 2026
    Review
  20. Article

20 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

8 authors at 7 institutions in 1 country.

Rong TaoDepartment of Hematology, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Lei FanThe First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China. fanlei3014@126.com.
Yongping SongThe Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.
Yu HuUnion Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, China.ORCID 0000-0002-2815-4568
Wei ZhangPeking Union Medical College Hospital, Beijing, China.
Yafei WangTianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Wei XuThe First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China.
Jianyong LiThe First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, China. jianyong.lijsh@outlook.com.
Jiangsu Cancer Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNJiangsu Province Hospital · CNShanghai Jiao Tong University · CNTianjin Medical University Cancer Institute and Hospital · CNWuhan Union Hospital · CNZhengzhou University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study (ORIENT-4) aimed to assess the efficacy and safety of sintilimab, a humanized anti-PD-1 antibody, in patients with relapsed/refractory extranodal NK/T cell lymphoma (r/r ENKTL). ORIENT-4 is a multicenter, single-arm, phase 2 clinical trial (NCT03228836). Patients with r/r ENKTL who failed to at least one asparaginase-based regimen were enrolled to receive sintilimab 200 mg intravenously every 3 weeks for up to 24 months. The primary endpoint was the objective response rate (ORR) based on Lugano 2014 criteria. Twenty-eight patients with r/r ENKTL were enrolled from August 31, 2017 to February 7, 2018. Twenty-one patients (75.0%, 95% CI: 55.1-89.3%) achieved an objective response. With a median follow-up of 30.4 months, the median overall survival (OS) was not reached. The 24-month OS rate was 78.6% (95% CI, 58.4-89.8%). Most treatment-related adverse events (TRAEs) were grade 1-2 (71.4%), and the most common TRAE was decreased lymphocyte count (42.9%). Serious adverse events (SAEs) occurred in 7 (25.0%) patients, and no patient died of adverse events. Sintilimab is effective and well tolerated in patients with r/r ENKTL and could be a novel therapeutic approach for the control of ENKTL in patients.

Indexed as

Lymphoma, Extranodal NK-T-CellAdolescentAdultAgedAntibodies, Monoclonal, HumanizedDisease-Free SurvivalFemaleFollow-Up StudiesHumansMaleMiddle AgedSurvival RateAntibodies, Monoclonal, Humanizedsintilimab

Identifiers

PMID34702811
PMCPMC8548511
OpenAlexW3210378023

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.