Evidence map›Paper›PMID 37207654›Full record

Trial reportCancer cell2023

Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309).

Yunpeng Yang, Jianji Pan, Hui Wang, Yuanyuan Zhao, Shenhong Qu, Nianyong Chen, Xiaozhong Chen, Yan Sun, Xiaohui He, Chaosu Hu and 20 more

2 registry-linked trialsOpen access · hybridAbstract readVideo-Audio MediaMulticenter StudyClinical Trial, Phase III
PubMed Publisher
In one paragraph

Trial report in Cancer cell, 2023. 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 138 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 10 pooled it
45.6field-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.

NCT03924986 phase3completednot on this map

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Compare the Efficacy and Safety of Tislelizumab (BGB-A317) Combined With Gemcitabine Plus Cisplatin Versus Placebo Combined With Gemcitabine Plus Cisplatin as First-Line Treatment for Recurrent or Metastatic Nasopharyngeal Cancer

TypeinterventionalSponsorBeiGeneRan2019 to 2023Enrolled263ConditionsRecurrent or Metastatic Nasopharyngeal CancerArmsTislelizumab, Placebo, Gemcitabine, Cisplatin
NCT07325539 phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Low-dose Radiotherapy (LDRT) Combined With Toripalimab and GP Chemotherapy for Recurrent/Metastatic Nasopharyngeal Carcinoma (LIGHT): A Multicentre, Open-Label, Single-Arm Phase II Clinical Study

TypeinterventionalSponsorSun Yat-sen UniversityRan2026 to 2030Enrolled55ConditionsNasopharyngeal Cancinoma (NPC), Nasopharangeal CancerArmsGemcitabine(GEM), Cisplatin, Toripalimab, LDRT
3 · Its place in the literature

Who cites it

138 citing papers in PubMed, 10 syntheses or guidelines pooled it, 198 citations in OpenAlex.

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  9. 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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  17. Anti-LAG-3 Antibody LBL-007 plus Tislelizumab and Chemotherapy as First-Line Therapy for Advanced Nasopharyngeal Carcinoma: A Multicenter Phase 2 Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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78 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors at 20 institutions in 1 country.

Yunpeng YangDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 16th Floor, No. 2 Building, Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong 510060, China.
Jianji PanDepartment of Head & Neck Radiation Oncology, Fujian Cancer Hospital, No. 420, Fuma Road, Jinan District, Fuzhou, Fujian 350014 China.
Hui WangThoracic Radiotherapy Department I, Hunan Cancer Hospital, No. 283, Tongzipo Road, Yuelu District, Changsha, Hunan 410013 China.
Yuanyuan ZhaoDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 16th Floor, No. 2 Building, Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong 510060, China.
Shenhong QuOtolaryngology Department of the People's Hospital of Guangxi Zhuang Autonomous Region, Cancer Research Institute of Guangxi Academy of Medical Sciences, No.6 Tao Yuan Road, Nan Ning, Guangxi 530021, China.
Nianyong ChenDepartment of Head and Neck Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, 37 Guoxuexiang, Wuhou District, Chengdu, Sichuan 610041, China.
Xiaozhong ChenDepartment of Head and Neck Radiotherapy, Zhejiang Cancer Hospital, 38 Guangji Road, Gongshu District, Hangzhou, Zhejiang 310022, China.
Yan SunRadiotherapy Department, Beijing Cancer Hospital, No. 52 Fucheng Road, Haidian District, Beijing 100142, China.
Xiaohui HeDepartment of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, No. 17 Panjiayuannanli, Chaoyang District, Beijing 100021, China.
Chaosu HuDepartment of Radiation, Fudan University Shanghai Cancer Centre, No. 270, Dong'an Road, Xuhui District, Shanghai 200032, China.
Lizhu LinDepartment of Oncology, the First Affiliated Hospital of Guangzhou Traditional Chinese Medicine University, No. 16 Airport Road, Baiyun District, Guangzhou, Guangdong 510405, China.
Qitao YuDepartment of Medical Oncology of Respiratory, the Affiliated Cancer Hospital of Guangxi Medical University, No. 71 Hedi Road, Nanning, Guangxi 530021, China.
Siyang WangHead and Neck Oncology Section One of The Fifth Affiliated Hospital Sun Yat-sen University, No. 52 Meihua East Road, Xiangzhou District, Zhuhai, Guangzhou Province 519000, China.
Guihua WangDepartment of Oncology, Changsha Central Hospital, No. 161, Shaoshan South Road, Changsha, Hunan 410004, China.
Feng LeiHead and Neck Radiotherapy Department, The People's Hospital of Zhongshan City, No. 2 Sunwen East Road, Zhongshan, Guangdong 528403, China.
Jiyu WenCancer Center, Nasopharyngeal Cancer Disease Center, Affiliated Hospital of Guangdong Medical University, No. 57 South Renmin Road, Zhanjiang, Guangdong 524000, China.
Kunyu YangCancer Centre, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1277 Jiefang Avenue, Wuhan, Hubei 430022, China.
Zhixiong LinDepartment of Radiation, Cancer Hospital of Shantou University Medical College, No. 7 Raoping Road, Shantou, Guangdong 515031, China.
Ye GuoDepartment of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, No. 1800, Yuntai Road, Shanghai 200123, China.
Shaoqing ChenDepartment of Oncology, the First Affiliated Hospital of Nanchang University, No. 17, Yongwaizheng Street, Nanchang, Jiangxi 330006, China.
Xiaoming HuangDepartment of Otolaryngology Head and Neck Surgery, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, No. 107 Yan Jiang West Road, Guangzhou, Guangdong 510120, China.
Yanjie WuClinical Development, BeiGene (Shanghai) Co., Ltd., Jing An Kerry Centre, 20/F, Tower 3, 1228 Middle Yan'an Road, Shanghai 200040, China.
Liang LiangClinical Biomarker Science and CDx Development, BeiGene (Beijing) Co., Ltd., 6 Jianguomenwai Avenue, SK Tower, 36th Floor, Chaoyang District, Beijing 100022, China.
Chenqi ChenClinical Development, BeiGene (Shanghai) Co., Ltd., Jing An Kerry Centre, 20/F, Tower 3, 1228 Middle Yan'an Road, Shanghai 200040, China.
Fan BaiClinical Development, BeiGene (Shanghai) Co., Ltd., Jing An Kerry Centre, 20/F, Tower 3, 1228 Middle Yan'an Road, Shanghai 200040, China.
Xiaopeng MaBioinformatics, BeiGene (Beijing) Co., Ltd. 30 Science Park Road, Zhongguancun Life Science Park, Changping District, Beijing 102206, China.
Yun ZhangClinical Biomarker Science and CDx Development, BeiGene (Beijing) Co., Ltd., 6 Jianguomenwai Avenue, SK Tower, 36th Floor, Chaoyang District, Beijing 100022, China.
Shiangjiin LeawClinical Development, BeiGene (Shanghai) Co., Ltd., Jing An Kerry Centre, 20/F, Tower 3, 1228 Middle Yan'an Road, Shanghai 200040, China.
Li ZhangDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 16th Floor, No. 2 Building, Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong 510060, China. Electronic address: zhangli@sysucc.org.cn.
Wenfeng FangDepartment of Medical Oncology of Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 16th Floor, No. 2 Building, Dongfeng East Road, Yuexiu District, Guangzhou, Guangdong 510060, China. Electronic address: fangwf@sysucc.org.cn.
BeiGene (China) · CNSun Yat-sen University · CNSun Yat-sen University Cancer Center · CNCancer Hospital of Shantou University Medical College · CNChangsha Central Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFifth Affiliated Hospital of Sun Yat-sen University · CNFirst Affiliated Hospital of Guangzhou University of Chinese Medicine · CNFudan University Shanghai Cancer Center · CNFujian Provincial Cancer Hospital · CNGuangdong Medical College · CNGuangxi Medical University · CNHunan Cancer Hospital · CNNanchang University · CNPeking University · CNShanghai East Hospital · CNSichuan University · CNSun Yat-sen Memorial Hospital · CNThe People's Hospital of Guangxi Zhuang Autonomous Region · CNUnion Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Checkpoint inhibitors are effective in recurrent/metastatic nasopharyngeal cancer (R/M NPC). RATIONALE-309 (NCT03924986) randomized 263 treatment-naive R/M NPC patients to tislelizumab or placebo every 3 weeks (Q3W), plus chemotherapy (Q3W for 4-6 cycles). At interim analysis, progression-free survival (PFS) was significantly longer with tislelizumab-chemotherapy versus placebo-chemotherapy (hazard ratio: 0.52; 95% confidence interval: 0.38, 0.73; p < 0.0001). PFS benefit for tislelizumab-chemotherapy versus placebo-chemotherapy was observed regardless of programmed death-ligand 1 expression. PFS after next line of treatment and overall survival showed favorable trends for tislelizumab-chemotherapy versus placebo-chemotherapy. The safety profile was similar between arms. Gene expression profiling (GEP) identified immunologically "hot" tumors, and showed an activated dendritic cell (DC) signature was associated with tislelizumab-chemotherapy PFS benefit. Our results support that tislelizumab-chemotherapy should be considered as first-line treatment for R/M NPC, and GEP and activated DC signature results may help identify patients who might benefit most from immunochemotherapy treatment. VIDEO ABSTRACT.

Indexed as

Nasopharyngeal NeoplasmsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsHumansNeoplasm Recurrence, LocalProgression-Free SurvivalAntibodies, Monoclonal, Humanizedtislelizumabbiomarkerclinical trialdouble-blindedgene expression profilingimmunotherapynasopharyngeal carcinomaPD-1 inhibitorrandomizedtislelizumab

Identifiers

PMID37207654
OpenAlexW4377020104

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.