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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061200025

Registered date:04/11/2020

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedEsophageal Squamous Cell Carcinoma
Date of first enrollment04/11/2020
Target sample size600
Countries of recruitmentSouth Koresa,Taiwan,Thailand,China,Hongkong,Brazil,United States of America,Canada,Belgium,France,Netherlands,Poland,Russian Federation,Spain,Japan
Study typeInterventional
Intervention(s)Durvalumab Placebo + definitive CRT Drug Durvalumab Durvalumab intravenous infusion Drug Placebo Durvalumab matching placebo for intravenous infusion Drug cisplatin+fluorouracil cisplatin+fluorouracil, as per Standard of Care Radiation Radiation 50-64Gy in total

Outcome(s)

Primary OutcomeProgression free survival (PFS) per RECIST 1.1 as assessed by BICR [ Time Frame: up to approximately 56 months ] To assess the efficacy in terms of PFS in all randomized patients and in patients with PD-L1 High tumors until disease progression
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteria18 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.
Exclude criteriaHistologically 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.

Related Information

Contact

Public contact
Name Shigeyuki Yamaji
Address Grad Front Osaka Tower B, 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneca K.K.
Scientific contact
Name Shigeyuki Yamaji
Address Grad Front Osaka Tower B, 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011
Telephone +81-6-4802-3533
E-mail RD-clinical-information-Japan@astrazeneca.com
Affiliation Astrazeneca.K.K