Evidence map›Paper›PMID 42834033›Full record

Trial reportNature communications2026

First-line tislelizumab plus chemotherapy versus placebo plus chemotherapy in unresectable advanced/metastatic esophageal squamous cell carcinoma: minimum 3-year survival follow-up of a randomized phase 3 trial (RATIONALE-306).

Harry H Yoon, Ken Kato, Eric Raymond, Richard Hubner, Yongqian Shu, Yueyin Pan, Sook Ryun Park, Takashi Kojima, Chen-Yuan Lin, Lucjan Wyrwicz and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Nature communications, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03783442 (A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT03783442 phase3completednot on this map

A Randomized, Placebo-Controlled, Double-Blind Phase 3 Study to Evaluate the Efficacy and Safety of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First-Line Treatment in Patients With Unresectable, Locally Advanced Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

TypeinterventionalSponsorBeiGeneRan2018 to 2024Enrolled649ConditionsEsophageal Squamous Cell Carcinoma (ESCC)ArmsCisplatin, Oxaliplatin, Fluorouracil (5-FU), Capecitabine, Paclitaxel
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
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

15 authors.

Harry H YoonDepartment of Oncology, Mayo Clinic, Rochester, MN, USA.ORCID 0000-0001-6208-3487
Ken KatoDepartment of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.ORCID 0000-0002-1733-5072
Eric RaymondDepartment of Medical Oncology & Hematology, Groupe Hospitalier Paris Saint-Joseph, Paris, France.
Richard HubnerDepartment of Medical Oncology, The Christie NHS Foundation Trust and Division of Cancer Sciences, University of Manchester, Manchester, UK.
Yongqian ShuDepartment of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Yueyin PanDepartment of Oncology, Anhui Provincial Hospital, Hefei, China.
Sook Ryun ParkDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.ORCID 0000-0003-4724-5016
Takashi KojimaDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.ORCID 0000-0002-2554-8334
Chen-Yuan LinDivision of Hematology and Oncology, Department of Internal Medicine, China Medical University Hospital, and China Medical University, Taichung, Taiwan.
Lucjan WyrwiczDepartment of Oncology and Radiotherapy, Maria Sklodowska-Curie National Cancer Research Institute, Warsaw, Poland.
David TougeronDepartment of Hepato-Gastroenterology, CHU de Poitiers, Poitiers, France.ORCID 0000-0002-8065-9635
Ryu IshiharaDepartment of Gastrointestinal Oncology, Osaka International Cancer Institute, Osaka, Japan.
Kaijun WangBiostatistics, BeOne Medicines, Ltd, San Carlos, CA, USA.
Yanyan PengClinical Biomarker, BeOne Medicines, Ltd, Shanghai, China.
Jianming XuDepartment of Gastrointestinal Oncology, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China. jmxu2003@163.com.ORCID 0000-0003-4467-6021

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

RATIONALE-306 previously demonstrated improved overall survival (OS) in participants treated with tislelizumab plus chemotherapy versus those receiving placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma, with a minimum follow-up of approximately 15 months. Exploratory long-term efficacy, safety, and quality of life (QoL) analyses after 36.0 months' minimum follow-up are reported here. Patients (649) were randomized 1:1 to tislelizumab 200 mg or placebo with investigator-chosen chemotherapy. Tislelizumab plus chemotherapy improves OS versus placebo plus chemotherapy in all patients (17.2 versus 10.6 months; hazard ratio, 0.70; 95% confidence interval, 0.59-0.80). At 3 years, 15.0% of patients treated with tislelizumab plus chemotherapy had not progressed versus 2.9% of those receiving placebo plus chemotherapy. No new safety signals have been identified. Median time to deterioration of physical functioning-a key QoL domain-has not been reached with tislelizumab plus chemotherapy versus 18.8 months with placebo plus chemotherapy. With longer follow-up, tislelizumab plus chemotherapy demonstrates long-lasting efficacy, tolerable safety, and favorable patient-reported outcomes, making it a suitable option for this patient population. ClinicalTrials.gov: NCT03783442 .

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm MetastasisQuality of LifeTreatment Outcome

Identifiers

PMID42834033
PMCPMC13639055

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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.