Trials / Completed
CompletedNCT03430843
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 512 (actual)
- Sponsor
- BeiGene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tislelizumab | 200 mg administered intravenously (IV) |
| DRUG | Paclitaxel | 135-175 mg /m² administered IV , or 80-100 mg/m\^2 administered IV according to local guidelines for standard of care |
| DRUG | Docetaxel | 75 mg/m\^2 administered IV or 70 mg/m\^2 IV in Japan |
| DRUG | Irinotecan | 125 mg/m\^2 administered IV |
Timeline
- Start date
- 2018-01-26
- Primary completion
- 2020-12-01
- Completion
- 2022-12-28
- First posted
- 2018-02-13
- Last updated
- 2024-10-26
- Results posted
- 2023-12-29
Locations
104 sites across 11 countries: United States, Belgium, China, France, Germany, Italy, Japan, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03430843. Inclusion in this directory is not an endorsement.