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NCT04677504 · ClinicalTrials.gov registry record · Phase 2
A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer
A Phase 2 study of Biliary Tract Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 162
- Enrollment target
- 20
- Study locations
NCT04677504: Completed Phase 2 study of Biliary Tract Cancer, sponsored by Hoffmann-La Roche.
NCT04677504 is a Phase 2 study of Biliary Tract Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 162 participants, below the 235-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04677504, a Phase 2 study of Biliary Tract Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 162 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treatment will consist of a chemotherapy combination phase followed by a cancer immunotherapy (CIT)/placebo phase.
Primary Outcome
PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator according to RECIST v1.1 or death from any cause (whichever occurs first)
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG Atezolizumab
- DRUG Cisplatin
- OTHER Placebo
- DRUG Gemcitabine
Study Locations (20)
Other
- Nanfang Hospital, Southern Medical University - Guangzhou
- Sir Run Run Shaw Hospital Zhejiang University - Hangzhou
- Zhongshan Hospital Fudan University - Shanghai
- Queen Mary Hospital; Dept. Of Haematology & Oncology - Hong Kong
- Prince of Wales Hosp; Dept. Of Clinical Onc - Shatin
- SP ZOZ Wojewódzki Szpital Specjalistyczny nr 4; Oddzial Onkologii Klinicznej - Bytom
- Uniwersyteckie Centrum Kliniczne; Klinika Onkologii i Radioterapii - Gdansk
- Szpital Wojewódzki im. Miko?aja Kopernika; Oddzia? Dzienny Chemioterapii - Koszalin
- NIO im Marii Sklodowskiej-Curie; Klinika Onkologii i Radioterapii - Warsaw
- Dolno?l?skie Centrum Onkologii; Oddzia? Onkologii Klinicznej i Chemioterapii - Wroc?aw
California
- City of Hope Cancer Center - Duarte
Massachusetts
- Massachusetts General Hospital - Boston
North Carolina
- Duke Cancer Center - Durham
Tennessee
- Sarah Cannon Research Institute / Tennessee Oncology - Nashville
Virginia
- University of Virginia - Charlottesville
Campania
- Fondazione Pascale; U.O. Sperimentazioni Cliniche - Naples
Emilia-Romagna
- Azienda Ospedaliero Universitaria di Bologna; Istituto di Ematologia "Lorenzo e Ariosto Seragnoli" - Bologna
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 162 participants |
| Start Date | 2021-02-23 |
| Est. Completion | 2023-08-25 |
| Phase | Phase 2 |
What the finished NCT04677504 record still lists
NCT04677504 is an interventional study that assigns participants to a tested intervention. The registered 162 participants enrollment target is mid-sized for trials with a published cap, below the 235-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (31% lower).
The record links to 1 condition, with Biliary Tract Cancer appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.
NCT04677504 names 20 study sites across 11 states, led by Other, California, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04677504 about?
NCT04677504 is a clinical study titled "A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer". This study will evaluate the efficacy and safety of atezolizumab with bevacizumab in combination with cisplatin and gemcitabine(CisGem), compared with atezolizumab in combination with CisGem, in participants with advanced biliary tract cancer (BTC) who have not received prior systemic therapy. Treat...
What is the current status of trial NCT04677504?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 162 participants. The study started on 2021-02-23. Estimated completion is 2023-08-25.
What conditions does trial NCT04677504 study?
This clinical trial studies the following conditions: Biliary Tract Cancer.
What interventions are being tested in trial NCT04677504?
The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG), Cisplatin (DRUG), Placebo (OTHER), Gemcitabine (DRUG).
Who is sponsoring clinical trial NCT04677504?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04677504 being conducted?
This trial has 20 study locations across California, Massachusetts, North Carolina, Tennessee, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04677504's enrollment target sits among peer trials
162 13th of 36 higher than 24 of 36 other Biliary Tract Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Biliary Tract Cancer 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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