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

NCT03875235

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Biliary Tract Neoplasms

Interventions: Durvalumab, Placebo

Countries: United States, Argentina, Bulgaria, Chile, China, France, Hong Kong, India

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

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion

1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
2. Patients with previously untreated disease if unresectable or metastatic at initial diagnosis will be eligible.
3. 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.
4. WHO/ECOG PS of 0 or 1

Exclusion

1. History of another primary malignancy
2. Brain metastases or spinal cord compression
3. Uncontrolled intercurrent illness
4. Major surgical procedure within 28 days prior to the first dose of IP.
5. Prior locoregional therapy such as radioembolization

Locations (126)

Los Angeles, California, United States
Orange, California, United States
Washington D.C., District of Columbia, United States
Fort Myers, Florida, United States
St. Petersburg, Florida, United States
Westwood, Kansas, United States
Louisville, Kentucky, United States
Burlington, Massachusetts, United States
St Louis, Missouri, United States
Chapel Hill, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Chattanooga, Tennessee, United States
Nashville, Tennessee, United States
Seattle, Washington, United States
Buenos Aires, Argentina
CABA, Argentina
CABA, Argentina
Ciudad de Buenos Aires, Argentina
Ciudad de Buenos Aires, Argentina
Rosario, Argentina
San Salvador de Jujuy, Argentina
Burgas, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Sofia, Bulgaria
Varna, Bulgaria
Santiago, Chile
Temuco, Chile
Baoding, China
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