Trial reportAdvances in therapy2026
Tislelizumab + Chemotherapy in Gastric Cancer: Long-Term RATIONALE-305 Randomized Trial Follow-up.
Trial report in Advances in therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03777657 (A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
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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, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) Plus Platinum and Fluoropyrimidine Versus Placebo Plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Integrating overall survival and health-related quality of life to prioritize first-line systemic therapies for unresectable advanced gastric cancer: a network meta-analysis.Frontiers in oncology · 2026Pooled it
- Cost-effectiveness of targeted therapy versus chemotherapy for patients with advanced or metastatic gastric cancer in China.Frontiers in pharmacology · 2026Article
- Characterization of the tumor microenvironment in locally advanced gastric cancer and identification of spatially predictive biomarkers associated with beneficial neoadjuvant immunochemotherapy.Frontiers in immunology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionTislelizumab + chemotherapy has shown promising results as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). We present long-term safety and efficacy outcomes from the RATIONALE-305 trial after 3 years of follow-up, focusing on the intent-to-treat (ITT) population and subgroups based on programmed death ligand-1 (PD-L1) expression.
methodsRATIONALE-305, a randomized, double-blind, placebo-controlled, phase 3 trial conducted across 146 centers in Asia, Europe, and North America (December 2018-February 2024), enrolled 997 adults with human epidermal growth factor receptor 2-negative advanced GC/GEJC, randomized 1:1 to receive tislelizumab + chemotherapy or placebo + chemotherapy. The primary endpoint was overall survival (OS) in patients with PD-L1 Tumor Area Positivity (TAP) score ≥ 5% and the ITT population. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), safety, and tolerability. At 3-year follow-up, 959 (96.2%) patients had discontinued or completed treatment. The minimum follow-up duration was 36.6 months.
resultsIn all randomized patients (n = 997), 69.4% male and 30.6% female, tislelizumab + chemotherapy improved OS versus placebo + chemotherapy [15.0 months (95% CI 13.6-16.5) vs. 12.9 months (95% CI 12.1-14.1); stratified hazard ratio (HR) 0.79]. Investigator-assessed PFS was also improved [6.9 months (95% CI 5.7-7.2) vs. 6.2 months (95% CI 5.6-6.9); stratified HR 0.79]. The ORR was higher with tislelizumab + chemotherapy. In patients with a PD-L1 TAP score ≥ 5% [n = 546 (54.8%)], similar OS and PFS benefits were observed compared to the ITT population. OS was 16.4 (95% CI 13.6-19.1) months versus 12.8 (95% CI 12.0-14.5) months, stratified HR 0.71 for tislelizumab + chemotherapy versus placebo + chemotherapy, respectively. PFS was 7.2 (95% CI 5.8-8.4) months versus 5.9 (95% CI, 5.6-7.0) months, stratified HR 0.69. No new safety signals were identified.
conclusionResults from RATIONALE-305 continued to show durable and improved efficacy outcomes with tislelizumab + chemotherapy versus placebo + chemotherapy at 3 years in advanced GC/GEJC, supporting PD-L1 as a potential prognostic biomarker.
trial registrationClinicalTrials.gov Identifier: NCT03777657.
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