Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Drug: PlaceboRadiation: Radiation
- Registration Number
- NCT04550260
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
- Detailed Description
Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in PD-L1 High population.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 640
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: Durvalumab + definitive CRT cisplatin + fluorouracil Durvalumab + concurrent chemoradiation Arm 1: Durvalumab + definitive CRT cisplatin + capecitabine Durvalumab + concurrent chemoradiation Arm 2: Placebo + definitive CRT Radiation Placebo + concurrent chemoradiation Arm 1: Durvalumab + definitive CRT Radiation Durvalumab + concurrent chemoradiation Arm 2: Placebo + definitive CRT cisplatin + fluorouracil Placebo + concurrent chemoradiation Arm 2: Placebo + definitive CRT Placebo Placebo + concurrent chemoradiation Arm 2: Placebo + definitive CRT cisplatin + capecitabine Placebo + concurrent chemoradiation Arm 1: Durvalumab + definitive CRT Durvalumab Durvalumab + concurrent chemoradiation
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) per RECIST 1.1 as assessed by BICR up to approximately 56 months To assess the efficacy in terms of PFS in PD-L1 High population
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) per RECIST 1.1 as assessed by BICR up to approximately 56 months To assess the efficacy in terms of PFS in all randomized patients.
Overall survival (OS) up to approximately 72 months To assess the efficacy in terms of OS in all randomized patients and in PD-L1 High population until the date of death
Trial Locations
- Locations (1)
Research Site
🇻🇳Ho Chi Minh, Vietnam