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NCT03777657 · ClinicalTrials.gov registry record · Phase 3
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
A Phase 3 study, sponsored by BeiGene.
- Completed
- Registry status
- Phase 3
- Development phase
- 997
- Enrollment target
NCT03777657: Completed Phase 3 study, sponsored by BeiGene.
NCT03777657 is a Phase 3 study that has completed, run by BeiGene. The registered enrollment target is 997 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03777657, a Phase 3 study, has completed, sponsored by BeiGene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 997 participants
- Enrollment target
Study Summary
This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Primary Outcome
Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method.
Interventions
- DRUG Placebo
- DRUG Capecitabine
- DRUG Cisplatin
- DRUG Oxaliplatin
- DRUG Tislelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 997 participants |
| Start Date | 2018-12-13 |
| Est. Completion | 2024-08-27 |
| Phase | Phase 3 |
What the finished NCT03777657 record still lists
NCT03777657 is an interventional study that assigns participants to a tested intervention. The registered 997 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03777657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03777657 about?
NCT03777657 is a clinical study titled "Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma". This study was designed to compare the efficacy and safety of tislelizumab plus chemotherapy versus placebo plus chemotherapy as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
What is the current status of trial NCT03777657?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 997 participants. The study started on 2018-12-13. Estimated completion is 2024-08-27.
What interventions are being tested in trial NCT03777657?
The interventions under investigation include: Placebo (DRUG), Capecitabine (DRUG), Cisplatin (DRUG), Oxaliplatin (DRUG), Tislelizumab (DRUG).
Who is sponsoring clinical trial NCT03777657?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03777657's enrollment target sits among peer trials
997 312th of 2000 higher than 1,689 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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