Phase 3
N=370
A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
Esophageal Squamous Cell Carcinoma (ESCC)
Bottom Line
View on ClinicalTrials.gov: NCT03957590 ↗Enrolled (actual)
370
Serious AEs
39.8%
Results posted
Apr 2026
Primary outcome: Primary: Progression-free Survival (PFS) — 29.0; 28.9 months — p=0.3016
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tislelizumab (Drug); Placebo (Drug); Paclitaxel (Drug); Cisplatin (Drug); Radiotherapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- BeiGene
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
29.0; 28.9 | 0.3016 |
| SECONDARY Overall Survival (OS) |
39.2; 48.2 | — |
| SECONDARY Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Oesophageal Cancer Module (OES18) Dysphagia, Reflux, Pain, and Eating Scales |
4.2; 7.1; 8.8; 7.6; -4.3; -4.5 | — |
| SECONDARY Change From Baseline in EORTC Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL), Physical Functioning, and Fatigue Scores |
2.461; 1.572; 4.104; 2.778; -2.864; 0.294 | — |
| SECONDARY Overall Response Rate (ORR) |
27.6; 38.9 | — |
| SECONDARY Duration of Response (DOR) |
NA; NA | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
185; 184; 84; 63 | — |
Summary
This is a phase 3, randomized, double-blind, placebo-controlled study to compare the efficacy and safety of tislelizumab (BGB-A317) versus placebo in combination with chemoradiotherapy in participants with localized esophageal squamous cell carcinoma (ESCC).
Eligibility Criteria
Key Inclusion Criteria
- Histologically confirmed diagnosis of localized ESCC and suitable for concurrent chemoradiotherapy (cCRT)
- Measurable and/or non-measurable disease defined per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
- Adequate organ function
Key Exclusion Criteria
- Indicators of severe malnutrition
- Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention within 2 weeks prior to randomization
- Known to be intolerable or resistant to treatment with the protocol-specified chemotherapy
- Received prior radiotherapy or therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1), PD-L2 or other immune-oncology therapies
- Active autoimmune diseases or history of autoimmune diseases that may relapse
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03957590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.