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COMPLETED Phase 2

A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer

NCT04677504 · View on ClinicalTrials.gov ↗

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

FieldValue
Enrollment Target 162 participants
Start Date 2021-02-23
Est. Completion 2023-08-25
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 162 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04677504 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04677504?

The interventions under investigation include: Bevacizumab (DRUG), Atezolizumab (DRUG), Cisplatin (DRUG), Placebo (OTHER), Gemcitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04677504?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial