Trials / Completed
CompletedNCT03957590
A Study to Investigate Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Participants With Localized Esophageal Squamous Cell Carcinoma
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Concurrent Chemoradiotherapy in Patients With Localized Esophageal Squamous Cell Carcinoma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | Administered intravenously (IV) |
| DRUG | Placebo | Placebo to match tislelizumab administered intravenously |
| DRUG | Paclitaxel | Administered as 135 mg/m² IV injection |
| DRUG | Cisplatin | Administered as 25 mg/m² IV injection |
| RADIATION | Radiotherapy | Administered at a total dose of 50.4 Gy in 28 fractions |
Timeline
- Start date
- 2019-06-11
- Primary completion
- 2025-01-08
- Completion
- 2025-03-31
- First posted
- 2019-05-21
- Last updated
- 2026-04-13
- Results posted
- 2026-04-13
Locations
33 sites across 1 country: China
Source: ClinicalTrials.gov record NCT03957590. Inclusion in this directory is not an endorsement.