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Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC

NCT04550260

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Durvalumab, Placebo, cisplatin + fluorouracil, cisplatin + capecitabine, Radiation

Countries: United States, Belgium, Brazil, Canada, China, France, Japan, Mexico

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 18 years or older at the time of signing the ICF.
* Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
* Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
* Patients with at least an evaluable lesion per RECIST 1.1.
* Mandatory provision of available tumor tissue for PD-L1 expression analysis.
* ECOG PS 0 or 1.
* Adequate organ and marrow function.
* Life expectancy of more than 3 months.

Exclusion Criteria:

* Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
* Prior anti-cancer treatment for ESCC.
* Patient with a great risk of perforation and massive bleeding.
* History of allogeneic organ transplantation.
* Active or prior documented autoimmune or inflammatory disorders.
* Uncontrolled intercurrent illness.
* History of another primary malignancy.
* Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
* Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
Locations (133)
  • Atlanta, Georgia, United States
  • Louisville, Kentucky, United States
  • Dallas, Texas, United States
  • Fairfax, Virginia, United States
  • Morgantown, West Virginia, United States
  • Brussels, Belgium
  • Charleroi, Belgium
  • Liège, Belgium
  • Namur, Belgium
  • Barretos, Brazil
  • Fortaleza, Brazil
  • Porto Alegre, Brazil
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • São José do Rio Preto, Brazil
  • Vitória, Brazil
  • Barrie, Ontario, Canada
  • Greater Sudbury, Ontario, Canada
  • Anyang, China
  • Beijing, China
  • Beijing, China
  • Bengbu, China
  • Changsha, China
  • Changzhi, China
  • Chengdu, China
  • Chongqing, China
  • Fuzhou, China
  • Fuzhou, China
  • Guangzhou, China
  • Guangzhou, China
  • + 103 more on CT.gov