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

A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma - KUNLUN

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2061200025

Enrollment

600

Registered

2020-11-04

Start date

2020-11-04

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Durvalumab Placebo + definitive CRT Drug Durvalumab Durvalumab intravenous infusion Drug Placebo Durvalumab matching placebo for intravenous infusion Drug cisplatin+fluorouracil cisplatin+fluorouracil

D910SC00001

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Countries

Belgium, Brazil, Canada, China, France, Hongkong, Japan, Netherlands, Poland, Russian Federation, South Koresa, Spain, Taiwan, Thailand, United States of America

Contacts

Public ContactKazushige Hibi

Astrazeneca K.K.

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026