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NCT03783442 · ClinicalTrials.gov registry record · Phase 3
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
A Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC), sponsored by BeiGene.
- Completed
- Registry status
- Phase 3
- Development phase
- 649
- Enrollment target
- 20
- Study locations
NCT03783442: Completed Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC), sponsored by BeiGene.
NCT03783442 is a Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC) that has completed, run by BeiGene. The registered enrollment target is 649 participants, above the 489-participant average among 5 other Esophageal Squamous Cell Carcinoma (ESCC) trials with a reported enrollment target (33% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03783442, a Phase 3 study of Esophageal Squamous Cell Carcinoma (ESCC), has completed, sponsored by BeiGene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 649 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG Oxaliplatin
- DRUG Paclitaxel
- DRUG Fluorouracil (5-FU)
Study Locations (20)
Other
- Institut Jules Bordet - Anderlecht
- Az Sint Jan Brugge - Bruges
- Grand Hopital de Charleroi Site Notre Dame - Charleroi
- UZ GENT - Ghent
- University Hospitals Leuven - Leuven
- Chc Montlegia - Liège
Beijing Municipality
- Beijing Friendship Hospital, Capital Medical University - Beijing
- The Fifth Medical Center of Chinese Pla General Hospital - Beijing
- Beijing Cancer Hospital - Beijing
- Peking Union Medical College Hospital - Beijing
Anhui
- Anhui Provincial Hospital - Hefei
- Anhui Provincial Cancer Hospital Aka West Branch of Anhui Province Hospital - Hefei
- The Second Hospital of Anhui Medical University - Hefei
Fujian
- The First Affiliated Hospital of Fujian Medical University - Fuzhou
- Fujian Cancer Hospital - Fuzhou
- Quanzhou First Affliated Hospital of Fujian Medical University - Quanzhou
Connecticut
- Smilow Cancer Hospital At Yale - New Haven
Texas
- Renovatio Clinical - The Woodlands
New South Wales
- Coffs Harbour Base Hospital - Coffs Harbour
Victoria
- St Vincents Hospital Melbourne - Fitzroy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 649 participants |
| Start Date | 2018-12-11 |
| Est. Completion | 2024-08-22 |
| Phase | Phase 3 |
What the finished NCT03783442 record still lists
NCT03783442 is an interventional study that assigns participants to a tested intervention. The registered 649 participants enrollment target is mid-sized for trials with a published cap, above the 489-participant average among 5 other Esophageal Squamous Cell Carcinoma (ESCC) trials with a reported enrollment target (33% higher).
The record links to 1 condition, with Esophageal Squamous Cell Carcinoma (ESCC) appearing as the primary indexed condition, and to 5 interventions - of which Capecitabine is the first listed.
NCT03783442 names 20 study sites across 8 states, led by Other, Beijing Municipality, Anhui.
Frequently Asked Questions
What is clinical trial NCT03783442 about?
NCT03783442 is a clinical study titled "A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma". 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).
What is the current status of trial NCT03783442?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 649 participants. The study started on 2018-12-11. Estimated completion is 2024-08-22.
What conditions does trial NCT03783442 study?
This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma (ESCC).
What interventions are being tested in trial NCT03783442?
The interventions under investigation include: Capecitabine (DRUG), Cisplatin (DRUG), Oxaliplatin (DRUG), Paclitaxel (DRUG), Fluorouracil (5-FU) (DRUG).
Who is sponsoring clinical trial NCT03783442?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03783442 being conducted?
This trial has 20 study locations across Connecticut, Texas, New South Wales, Victoria, Anhui. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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