Trials / Completed
CompletedNCT03783442
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 649 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophageal squamous cell carcinoma (ESCC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cisplatin | Cisplatin 60-80 mg/m² administered by intravenous infusion every 3 weeks. Cisplatin was used as the platinum agent in China, Taiwan, and Japan. |
| DRUG | Oxaliplatin | Oxaliplatin 130 mg/m² administered by intravenous infusion every 3 weeks. |
| DRUG | Fluorouracil (5-FU) | Fluorouracil 750-800 mg/m² administered by intravenous infusion on Days 1-5 of each treatment cycle. |
| DRUG | Capecitabine | Capecitabine 1000 mg/m² administered orally twice daily on Days 1-14 of each treatment cycle |
| DRUG | Paclitaxel | Paclitaxel 175 mg/m² administered by intravenous infusion every 3 weeks. |
| BIOLOGICAL | Tislelizumab | Tislelizumab 200 mg administered by intravenous infusion every 3 weeks. |
| DRUG | Placebo | Placebo to match tislelizumab administered by intravenous infusion every 3 weeks. |
Timeline
- Start date
- 2018-12-11
- Primary completion
- 2022-02-28
- Completion
- 2024-08-22
- First posted
- 2018-12-21
- Last updated
- 2025-07-29
- Results posted
- 2023-11-07
Locations
124 sites across 16 countries: United States, Australia, Belgium, China, Czechia, France, Germany, Italy, Japan, Poland, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03783442. Inclusion in this directory is not an endorsement.