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

JRCT ID: jRCT2061200025

Registered date:04/11/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal Squamous Cell Carcinoma
• Date of first enrollment: 04/11/2020
• Target sample size: 600
• Countries of recruitment: South Koresa,Japan,Taiwan,Japan,Thailand,Japan,China,Japan,Hongkong,Japan,Brazil,Japan,United States of America,Japan,Canada,Japan,Belgium,Japan,France,Japan,Netherlands,Japan,Poland,Japan,Russian Federation,Japan,Spain,Japan
• Study type: Interventional

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 Outcome

Progression 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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT04550260