Evidence map›Paper›PMID 33492986›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02).

Feng-Hua Wang, Xiao-Li Wei, Jifeng Feng, Qi Li, Nong Xu, Xi-Chun Hu, Wangjun Liao, Yi Jiang, Xiao-Yan Lin, Qing-Yuan Zhang and 14 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 221 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
221citing papers in PubMed, 11 pooled it
22.5field-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.

NCT04907370 phase3active not recruitingnot on this map

Toripalimab Combined With Induction Chemotherapy Followed by Radiotherapy Alone or Concurrent Chemoradiotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multi-center, Randomized Controlled Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2021 to 2027Enrolled532ConditionsNasopharyngeal CarcinomaArmsPD-1 blocking antibody, Gemcitabine, Cisplatin (80mg/m2), Cisplatin (100mg/m2), Intensity-modulated radiotherapy
NCT04961788 phase2unknown statusnot on this map

A Phase 2 Study of Anti-PD1 Antibody Toripalimab Combined With Gemox (Gemcitabine and Oxaliplatin) as First-line Therapy in Patients With Advanced or Unresectable Intrahepatic Cholangiocarcinoma

TypeinterventionalSponsorShanghai Zhongshan HospitalRan2021 to 2022Enrolled30ConditionsIntrahepatic CholangiocarcinomaArmsGemox combimed PD1 antibody
NCT04978012 phase2unknown statusnot on this map

A Phase II Single-site the Study of the Efficacy and Safety of Fluzoparib and Camrelizumab in Treating Patients With Recurrent/Metastatic Nasopharyngeal Carcinoma That Progressed After First-line Chemotherapy

TypeinterventionalSponsorFudan UniversityRan2021 to 2025Enrolled48ConditionsNasopharyngeal Carcinoma, Nasopharyngeal CancerArmsFluzoparib and Camrelizumab
NCT06239727 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Reduced-dose Radiotherapy for Stage III Nasopharyngeal Carcinoma Based on the Treatment Response: an Open Label, Non-Inferiority, Multicenter, Randomized Phase 3 Trial

TypeinterventionalSponsorSun Yat-sen UniversityRan2024 to 2030Enrolled593ConditionsNasopharyngeal CarcinomaArmsPD-1 blocking antibody, Gemcitabine, Cisplatin (80 mg/m2), Reduced-dose Intensity-modulated radiotherapy, Conventional-dose Intensity-modulated radiotherapy
3 · Its place in the literature

Who cites it

221 citing papers in PubMed, 11 syntheses or guidelines pooled it, 341 citations in OpenAlex.

  1. Pooled it
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  3. Effectiveness and safety of camrelizumab plus apatinib in treating recurrent/metastatic nasopharyngeal carcinoma: a single-arm meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
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  7. Immune checkpoint inhibitor combined with chemotherapy versus chemotherapy alone in the first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: a meta-analysis of random controlled trials.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
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  12. A Multicentre Phase II Study of Trifluridine/Tipiracil in Recurrent/Metastatic Platinum-Resistant Nasopharyngeal Carcinomas.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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161 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

24 authors at 17 institutions in 1 country.

Feng-Hua WangDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University, Guangzhou, China.
Xiao-Li WeiDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University, Guangzhou, China.
Jifeng FengJiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing, China.
Qi LiShanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Nong XuThe First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Xi-Chun HuFudan University Shanghai Cancer Center, Shanghai, China.ORCID 0000-0002-9892-699X
Wangjun LiaoCancer Center of Nan Fang Hospital, Guangzhou, China.
Yi JiangThe Affiliated Cancer Hospital of Shantou University, Shantou, China.
Xiao-Yan LinUnion Hospital of Fujian Medical University, Fuzhou, China.
Qing-Yuan ZhangThe affiliated Cancer Hospital of Harbin Medical University, Harbin, China.
Xiang-Lin YuanWuhan Tongji Hospital, Wuhan, China.
Hai-Xin HuangLiuzhou Worker's Hospital, Liuzhou, China.
Ye ChenCancer Center of West China Hospital of Sichuan University, Chengdu, China.
Guang-Hai DaiBeijing 301 Hospital, Beijing, China.ORCID 0000-0002-7339-3840
Jian-Hua ShiLinyi Cancer Hospital, Linyi, China.
Lin ShenBeijing Cancer Hospital & Institute, Beijing, China.ORCID 0000-0002-8798-4756
Shu-Jun YangHenan Cancer Hospital, Zhengzhou, China.
Yong-Qian ShuJiangsu Provincial Hospital, Nanjing, China.
Yun-Peng LiuThe First Hospital of China Medical University, Shenyang, China.
Weifeng WangOrigiMed, Shanghai, China.
Hai WuShanghai Junshi Biosciences Co, Ltd, Shanghai, China.
Hui FengShanghai Junshi Biosciences Co, Ltd, Shanghai, China.
Sheng YaoShanghai Junshi Biosciences Co, Ltd, Shanghai, China.
Rui-Hua XuDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University, Guangzhou, China.ORCID 0000-0001-9771-8534
Sun Yat-sen University · CNFirst Affiliated Hospital Zhejiang University · CNFirst Hospital of China Medical University · CNFudan University Shanghai Cancer Center · CNFujian Medical University · CNHarbin Medical University · CNHenan Cancer Hospital · CNJiangsu Cancer Hospital · CNJiangsu Provincial Hospital of Traditional Chinese Medicine · CNLiuzhou Maternal and Child Health Hospital · CNNanfang Hospital · CNPeking University · CNShanghai Jiao Tong University · CNShantou University · CNSichuan University · CNTongji Hospital · CNUnimed Medical Institute · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeAs yet, no checkpoint inhibitor has been approved to treat nasopharyngeal carcinoma (NPC). This study was aimed to evaluate the antitumor activity, safety, and biomarkers of toripalimab, a new programmed death-1 (PD-1) inhibitor for recurrent or metastatic NPC (RM-NPC) refractory to standard chemotherapy. PATIENTS AND

methodsIn this single-arm, multicenter phase II study, patients with RM-NPC received 3 mg/kg toripalimab once every 2 weeks via intravenous infusion until confirmed disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR). The secondary end points included safety, duration of response (DOR), progression-free survival (PFS), and overall survival (OS).

resultsAmong all 190 patients, the ORR was 20.5% with median DOR 12.8 months, median PFS 1.9 months, and median OS 17.4 months. Among 92 patients who failed at least two lines of systemic chemotherapy, the ORR was 23.9%. The ORRs were 27.1% and 19.4% in PD-L1+ and PD-L1- patients, respectively (

conclusionThe POLARIS-02 study demonstrated a manageable safety profile and durable clinical response of toripalimab in patients with chemorefractory metastatic NPC. An early decrease in plasma EBV DNA copy number correlated with favorable response.

Indexed as

Neoplasm Recurrence, LocalAdultAgedAntibodies, Monoclonal, HumanizedChinaChromosomes, Human, Pair 11Disease ProgressionDNA, ViralETS Translocation Variant 6 ProteinFemaleHerpesvirus 4, HumanHumansImmune Checkpoint InhibitorsMaleMiddle AgedNasopharyngeal CarcinomaAntibodies, Monoclonal, HumanizedDNA, ViralETS Translocation Variant 6 ProteinImmune Checkpoint InhibitorsPDCD1 protein, humanProgrammed Cell Death 1 ReceptorProto-Oncogene Proteins c-etsRepressor Proteinstoripalimab

Identifiers

PMID33492986
PMCPMC8078488
OpenAlexW3124559501

What Socratic holds

Textmetadata
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 Socratic graph.