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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04677504
The ClinicalTrials.gov registry entry for NCT04677504 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 235-participant average among 36 other Biliary Tract Cancer trials with a reported enrollment target (31% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 11 distinct geographic areas - top geographies include 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.
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