Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022
Tislelizumab Versus Chemotherapy as Second-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma (RATIONALE-302): A Randomized Phase III Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03430843 (A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab), which is not on this map. Cited by 207 papers, 24 of them syntheses that pooled 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.
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.
A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma
Who cites it
207 citing papers in PubMed, 24 syntheses or guidelines pooled it, 298 citations in OpenAlex.
- 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 · 2026Pooled it
- SEOM-GEMCAD-TTD clinical guideline for the diagnosis and treatment of esophageal cancer (update 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- Sex-based responses to immunotherapy in esophageal cancer: insights from a meta-analysis.BMC gastroenterology · 2026Pooled it
- Comparative Efficacy and Safety of Tislelizumab in Second-Line Esophageal Squamous Cell Carcinoma: Systematic Literature Review and Simulated Treatment Comparisons.Advances in therapy · 2026Pooled it
- Associations of PD-L1 expression status, tumor histology and patient ethnic background with immunotherapy outcomes in patients with advanced esophageal cancer.Frontiers in pharmacology · 2026Pooled it
- What determines value? Exploring value characteristics of novel therapies for digestive system cancers.Frontiers in immunology · 2026Pooled it
- Does chemotherapy regimen matter for first-line immunochemotherapy in low PD-L1-expressing esophageal squamous cell carcinoma? A systemic review and meta-analysis.Esophagus : official journal of the Japan Esophageal Society · 2026Pooled it
- Overall survival with immune checkpoint inhibitors across treatment settings and clinical and PD-L1-defined subgroups in advanced esophageal squamous cell carcinoma: a systematic review and meta-analysis of randomized trials.Frontiers in immunology · 2026Pooled it
- Efficacy and safety of tislelizumab in patients with advanced esophageal squamous cell carcinoma: a systematic review and meta-analysis.Journal of the Egyptian National Cancer Institute · 2025Pooled it
- Haematological toxicities with immune checkpoint inhibitors in digestive system tumors: a systematic review and network meta-analysis of randomized controlled trials.Clinical and experimental medicine · 2025Pooled it
- Optimal early endpoint for second-line or subsequent immune checkpoint inhibitors in previously treated advanced solid cancers: a systematic review.BMC cancer · 2025Pooled it
- Guideline
- The prognostic value of pretreatment neutrophil-lymphocyte ratio and platelet-lymphocyte ratio in patients with esophageal cancer undergoing immunotherapy: a systematic review and meta-analysis.Frontiers in oncology · 2025Pooled it
- Application of chemotherapy combined with immunotherapy in first-line treatment of advanced esophageal cancer: fluorouracil or paclitaxel? - a meta-analysis.Frontiers in oncology · 2025Pooled it
- Outcomes and Prognostic Factors of Patients with Unresectable or Metastatic Esophageal Squamous Cell Carcinoma Undergoing Immunotherapy- Versus Chemotherapy-Based Regimens: Systematic Review and Pooled Analyses.Journal of gastrointestinal cancer · 2024Pooled it
- Efficacy and safety of PD-1 inhibitors as second-line treatment for advanced squamous esophageal cancer: a systematic review and network meta-analysis with a focus on PD-L1 expression levels.Frontiers in immunology · 2024Pooled it
- The risk of endocrine immune-related adverse events induced by PD-1 inhibitors in cancer patients: a systematic review and meta-analysis.Frontiers in oncology · 2024Pooled it
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of gastrointestinal cancer.Journal for immunotherapy of cancer · 2023Guideline
- Clinical Benefit of First-Line Programmed Death-1 Antibody Plus Chemotherapy in Low Programmed Cell Death Ligand 1-Expressing Esophageal Squamous Cell Carcinoma: A Post Hoc Analysis of JUPITER-06 and Meta-Analysis.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Pooled it
- Clinical benefits of PD-1 inhibitors in specific subgroups of patients with advanced esophageal squamous cell carcinoma: a systematic review and meta-analysis of phase 3 randomized clinical trials.Frontiers in immunology · 2023Pooled it
147 more citing papers are in PubMed but not listed here.
Corrections and comments
- Erratum issued
Authors and funding
31 authors at 20 institutions in 10 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePatients with advanced or metastatic esophageal squamous cell carcinoma (ESCC) have poor prognosis. For these patients, treatment options are limited after first-line systemic therapy. PATIENTS AND
methodsIn this open-label phase III clinical study, patients with advanced or metastatic ESCC, whose tumor progressed after first-line systemic treatment, were randomly assigned (1:1) to receive intravenous tislelizumab, an anti-programmed cell death protein 1 antibody, 200 mg every 3 weeks or chemotherapy (investigator's choice of paclitaxel, docetaxel, or irinotecan). The primary end point was overall survival (OS) in all patients. The key secondary end point was OS in patients with programmed death-ligand 1 tumor area positivity (TAP) score ≥ 10%.
resultsIn total, 512 patients across 11 countries/regions were randomly assigned. At final analysis, conducted after 410 death events occurred, OS was significantly longer with tislelizumab versus chemotherapy in all patients (median, 8.6
conclusionTislelizumab significantly improved OS compared with chemotherapy as second-line therapy in patients with advanced or metastatic ESCC, with a tolerable safety profile. Patients with programmed death-ligand 1 TAP ≥ 10% also demonstrated statistically significant survival benefit with tislelizumab versus chemotherapy.
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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.