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NCT03412773 · ClinicalTrials.gov registry record · Phase 3
A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)
A Phase 3 study of Hepatocellular Carcinoma (HCC), sponsored by BeiGene.
- Completed
- Registry status
- Phase 3
- Development phase
- 684
- Enrollment target
- 20
- Study locations
NCT03412773: Completed Phase 3 study of Hepatocellular Carcinoma (HCC), sponsored by BeiGene.
NCT03412773 is a Phase 3 study of Hepatocellular Carcinoma (HCC) that has completed, run by BeiGene. The registered enrollment target is 684 participants, above the 306-participant average among 15 other Hepatocellular Carcinoma (HCC) trials with a reported enrollment target (124% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03412773, a Phase 3 study of Hepatocellular Carcinoma (HCC), has completed, sponsored by BeiGene.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 684 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the main Phase 3 study, a preliminary assessment of safety and tolerability (the Safety Run-In Sub-study) was conducted in Japan.
Primary Outcome
An adverse event (AE) is any unfavorable or unintended sign (e.g., abnormal lab result), symptom, or disease temporally associated with study drug use, regardless of causality. A serious adverse event (SAE) is defined as any adverse event that: * Resulted in death * Was life-threatening * Required or prolonged hospitalization * Caused disability/incapacity * Lead to a congenital anomaly/birth defect * Was deemed medically significant by the investigator (e.g., required intervention to prevent
Conditions Studied
Interventions
- DRUG Tislelizumab
- DRUG Sorafenib
Study Locations (20)
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing
- Military Hospital of China - Beijing
- Beijing Youan Hospital, Capital Medical University - Beijing
- Beijing Cancer Hospital - Beijing
- Peking Union Medical College Hospital - Beijing
- Chinese Pla General Hospital - Beijing
Anhui
- The First Affiliated Hospital of Bengbu Medical College - Bengbu
- Anhui Provincial Hospital - Hefei
- The First Affiliated Hospital of Anhui Medical University - Hefei
- The Second Hospital of Anhui Medical University - Hefei
California
- Providence Medical Foundation - Fullerton
- UCLA Hematologyoncology - Los Angeles
- Chao Family Comprehensive Cancer Center - Orange
Massachusetts
- Massachusetts General Hospital - Boston
New Jersey
- Umdnj Njms - Newark
New York
- Rj Zuckerberg Cancer Center - Lake Success
Ohio
- Xcancerdayton Physician Network - Dayton
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 684 participants |
| Start Date | 2017-12-18 |
| Est. Completion | 2023-12-14 |
| Phase | Phase 3 |
What the finished NCT03412773 record still lists
NCT03412773 is an interventional study that assigns participants to a tested intervention. The registered 684 participants enrollment target is mid-sized for trials with a published cap, above the 306-participant average among 15 other Hepatocellular Carcinoma (HCC) trials with a reported enrollment target (124% higher).
The record links to 1 condition, with Hepatocellular Carcinoma (HCC) appearing as the primary indexed condition, and to 2 interventions - of which Tislelizumab is the first listed.
NCT03412773 names 20 study sites across 10 states, led by Beijing Municipality, Anhui, California.
Frequently Asked Questions
What is clinical trial NCT03412773 about?
NCT03412773 is a clinical study titled "A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)". This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not be surgically removed. Before enrolling Japanese participants in the ma...
What is the current status of trial NCT03412773?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 684 participants. The study started on 2017-12-18. Estimated completion is 2023-12-14.
What conditions does trial NCT03412773 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma (HCC).
What interventions are being tested in trial NCT03412773?
The interventions under investigation include: Tislelizumab (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT03412773?
This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03412773 being conducted?
This trial has 20 study locations across California, Massachusetts, New Jersey, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03412773's enrollment target sits among peer trials
684 3rd of 15 higher than 13 of 15 other Hepatocellular Carcinoma (HCC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma (HCC) 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.
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