NCT03875235Active, not recruitingPhase 3

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)

A Phase III Randomized, Double-Blind Placebo Controlled, Multi-Regional, International Study of Durvalumab in Combination With Gemcitabine Plus Cisplatin Versus Placebo in Combination With Gemcitabine Plus Cisplatin for Patients With First-Line Advanced Biliary Tract Cancers

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1).

Status (registry): Active, not recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 810 (actual)
First submitted: 13 Mar 2019
Start date: 16 Apr 2019
Primary completion date: 11 Aug 2021
Lead sponsor: AstraZeneca
Diseases: Liver and biliary tract cancer
NCT number: NCT03875235
EU CT number: 2023-507405-34-00
EudraCT number: 2018-004688-30

What you commit to

Study type: Interventional · Phase 3
Participants enrolled: 810
From 16 Apr 2019 to the primary completion date, 11 Aug 2021
106 sites in 17 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

Inclusion
Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
Patient with recurrent disease \>6 months after curative surgery or \>6 months after the completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.
WHO/ECOG PS of 0 or 1
- Exclusion
History of another primary malignancy
Brain metastases or spinal cord compression
Uncontrolled intercurrent illness
Major surgical procedure within 28 days prior to the first dose of IP.
Prior locoregional therapy such as radioembolization

Age in the registry: 18 years to 130 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (106)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
- Coordinator of this site? Confirm its status	Buenos Aires	Argentina	Unknown status
- Coordinator of this site? Confirm its status	CABA	Argentina	Unknown status
- Coordinator of this site? Confirm its status	Ciudad de Buenos Aires	Argentina	Unknown status
- Coordinator of this site? Confirm its status	Rosario	Argentina	Unknown status
- Coordinator of this site? Confirm its status	San Salvador de Jujuy	Argentina	Unknown status
- Coordinator of this site? Confirm its status	Burgas	Bulgaria	Unknown status
- Coordinator of this site? Confirm its status	Sofia	Bulgaria	Unknown status
- Coordinator of this site? Confirm its status	Varna	Bulgaria	Unknown status
- Coordinator of this site? Confirm its status	Santiago	Chile	Unknown status
- Coordinator of this site? Confirm its status	Temuco	Chile	Unknown status
- Coordinator of this site? Confirm its status	Baoding	China	Unknown status
- Coordinator of this site? Confirm its status	Beijing	China	Unknown status
- Coordinator of this site? Confirm its status	Bengbu	China	Unknown status
- Coordinator of this site? Confirm its status	Chongqing	China	Unknown status
- Coordinator of this site? Confirm its status	Foshan	China	Unknown status
- Coordinator of this site? Confirm its status	Guangzhou	China	Unknown status
- Coordinator of this site? Confirm its status	Hangzhou	China	Unknown status
- Coordinator of this site? Confirm its status	Harbin	China	Unknown status
- Coordinator of this site? Confirm its status	Hefei	China	Unknown status
- Coordinator of this site? Confirm its status	Jinan	China	Unknown status
- Coordinator of this site? Confirm its status	Nanchang	China	Unknown status
- Coordinator of this site? Confirm its status	Nanjing	China	Unknown status
- Coordinator of this site? Confirm its status	Shandong	China	Unknown status
- Coordinator of this site? Confirm its status	Shanghai	China	Unknown status
- Coordinator of this site? Confirm its status	Shenyang	China	Unknown status
- Coordinator of this site? Confirm its status	Suzhou	China	Unknown status
- Coordinator of this site? Confirm its status	Xi'an	China	Unknown status
- Coordinator of this site? Confirm its status	Zhengzhou	China	Unknown status
- Coordinator of this site? Confirm its status	Zhuhai	China	Unknown status
- Coordinator of this site? Confirm its status	Clichy	France	Unknown status
- Coordinator of this site? Confirm its status	Dijon	France	Unknown status
- Coordinator of this site? Confirm its status	Montpellier	France	Unknown status
- Coordinator of this site? Confirm its status	Nice	France	Unknown status
- Coordinator of this site? Confirm its status	Paris	France	Unknown status
- Coordinator of this site? Confirm its status	Pessac	France	Unknown status
- Coordinator of this site? Confirm its status	Poitiers	France	Unknown status
- Coordinator of this site? Confirm its status	Bristol	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	Cambridge	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	London	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	Manchester	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	Oxford	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	Romford	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	Sheffield	United Kingdom	Unknown status
- Coordinator of this site? Confirm its status	Hong Kong	Hong Kong	Unknown status
- Coordinator of this site? Confirm its status	Kowloon	Hong Kong	Unknown status
- Coordinator of this site? Confirm its status	Gūrgaon	India	Unknown status
- Coordinator of this site? Confirm its status	Kolkata	India	Unknown status
- Coordinator of this site? Confirm its status	Mumbai	India	Unknown status
- Coordinator of this site? Confirm its status	New Delhi	India	Unknown status
- Coordinator of this site? Confirm its status	Faenza	Italy	Unknown status
- Coordinator of this site? Confirm its status	Florence	Italy	Unknown status
- Coordinator of this site? Confirm its status	Milan	Italy	Unknown status
- Coordinator of this site? Confirm its status	Naples	Italy	Unknown status
- Coordinator of this site? Confirm its status	Roma	Italy	Unknown status
- Coordinator of this site? Confirm its status	Verona	Italy	Unknown status
- Coordinator of this site? Confirm its status	Chūōku	Japan	Unknown status
- Coordinator of this site? Confirm its status	Kashiwa	Japan	Unknown status
- Coordinator of this site? Confirm its status	Kitaadachi-gun	Japan	Unknown status
- Coordinator of this site? Confirm its status	Mitaka-shi	Japan	Unknown status
- Coordinator of this site? Confirm its status	Osaka	Japan	Unknown status
- Coordinator of this site? Confirm its status	Suita-shi	Japan	Unknown status
- Coordinator of this site? Confirm its status	Wakayama	Japan	Unknown status
- Coordinator of this site? Confirm its status	Yokohama	Japan	Unknown status
- Coordinator of this site? Confirm its status	Seongnam-si	South Korea	Unknown status
- Coordinator of this site? Confirm its status	Seoul	South Korea	Unknown status
- Coordinator of this site? Confirm its status	Gdansk	Poland	Unknown status
- Coordinator of this site? Confirm its status	Lodz	Poland	Unknown status
- Coordinator of this site? Confirm its status	Olsztyn	Poland	Unknown status
- Coordinator of this site? Confirm its status	Poznan	Poland	Unknown status
- Coordinator of this site? Confirm its status	Warsaw	Poland	Unknown status
- Coordinator of this site? Confirm its status	Wroclaw	Poland	Unknown status
- Coordinator of this site? Confirm its status	Barnaul	Russia	Unknown status
- Coordinator of this site? Confirm its status	Kostroma	Russia	Unknown status
- Coordinator of this site? Confirm its status	Moscow	Russia	Unknown status
- Coordinator of this site? Confirm its status	Omsk	Russia	Unknown status
- Coordinator of this site? Confirm its status	Saint Petersburg	Russia	Unknown status
- Coordinator of this site? Confirm its status	Bangkok	Thailand	Unknown status
- Coordinator of this site? Confirm its status	Hat Yai	Thailand	Unknown status
- Coordinator of this site? Confirm its status	Khon Kaen	Thailand	Unknown status
- Coordinator of this site? Confirm its status	Muang	Thailand	Unknown status
- Coordinator of this site? Confirm its status	Si Sa Ket	Thailand	Unknown status
- Coordinator of this site? Confirm its status	Chiayi City	Taiwan	Unknown status
- Coordinator of this site? Confirm its status	Kaohsiung City	Taiwan	Unknown status
- Coordinator of this site? Confirm its status	Taichung	Taiwan	Unknown status
- Coordinator of this site? Confirm its status	Tainan	Taiwan	Unknown status
- Coordinator of this site? Confirm its status	Taipei	Taiwan	Unknown status
- Coordinator of this site? Confirm its status	Taoyuan	Taiwan	Unknown status
- Coordinator of this site? Confirm its status	Burlington	United States	Unknown status
- Coordinator of this site? Confirm its status	Chapel Hill	United States	Unknown status
- Coordinator of this site? Confirm its status	Chattanooga	United States	Unknown status
- Coordinator of this site? Confirm its status	Fort Myers	United States	Unknown status
- Coordinator of this site? Confirm its status	Los Angeles	United States	Unknown status
- Coordinator of this site? Confirm its status	Louisville	United States	Unknown status
- Coordinator of this site? Confirm its status	Nashville	United States	Unknown status
- Coordinator of this site? Confirm its status	Orange	United States	Unknown status
- Coordinator of this site? Confirm its status	Philadelphia	United States	Unknown status
- Coordinator of this site? Confirm its status	Portland	United States	Unknown status
- Coordinator of this site? Confirm its status	Seattle	United States	Unknown status
- Coordinator of this site? Confirm its status	St Louis	United States	Unknown status
- Coordinator of this site? Confirm its status	St. Petersburg	United States	Unknown status
- Coordinator of this site? Confirm its status	Washington D.C.	United States	Unknown status
- Coordinator of this site? Confirm its status	Westwood	United States	Unknown status
- Coordinator of this site? Confirm its status	Ankara	Turkey (Türkiye)	Unknown status
- Coordinator of this site? Confirm its status	Istanbul	Turkey (Türkiye)	Unknown status
- Coordinator of this site? Confirm its status	Izmir	Turkey (Türkiye)	Unknown status
- Coordinator of this site? Confirm its status	Mersin	Turkey (Türkiye)	Unknown status

Related publications

Durvalumab Plus Chemotherapy for Advanced Biliary Tract Cancer: A Post Hoc Analysis of the TOPAZ-1 Randomized Clinical Trial.JAMA Oncol · 2026 · PMID 42424063

This page is information, not medical advice. Discuss any trial with your doctor.