台灣臨床試驗主持人資料庫|TPIDB

問卷

Log In

繁中 EN

TPIDB

TPIDB Outstanding PI

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberD910SC00001

NCT Number(ClinicalTrials.gov Identfier)NCT04550260

Active

2020-08-31 - 2027-12-31

Phase III

Recruiting11

ICD-10C15.9

Malignant neoplasm of esophagus, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9150.9

Malignant neoplasm of esophagus, unspecified

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)

Trial Applicant
Sponsor

AstraZeneca
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Ming-Huang Chen 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林進清無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Meng-Jer Hsieh Division of Hematology & Oncology

E-DA Hospital

Co-Principal Investigator

饒坤銘 Division of Hematology & Oncology
裴松南 Division of Hematology & Oncology
蔡郁棻 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chen-Yuan Lin 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hung Hsu 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-CHEN WU Digestive System Department

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Meng-Jer Hsieh 無

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shau-Hsuan Li 無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Mo Hou 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 康乃文無

Chi Mei Medical Center

Co-Principal Investigator

吳鴻昌無
黃健泰 Division of Hematology & Oncology
郭雨萱無
陳威宇 Division of Hematology & Oncology
馮盈勳 Division of Hematology & Oncology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YI-CHUN LIU 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Esophageal Squamous Cell Carcinoma(ESCC)

Objectives

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). 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 all randomized patients (intent-to-treat [ITT] population) and PFS in patients with PD-L1 high tumors (PD-L1 High population).

Test Drug

Durvalumab

Active Ingredient

Durvalumab(MEDI4736)

Dosage Form

Humanized anti-PD-L1 mAb

Dosage

injecion

Endpoints

Primary Outcome Measures :
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

Secondary Outcome Measures :
Overall survival (OS) [ Time Frame: up to approximately 72 months ]
To assess the efficacy in terms of OS in all randomized patients and in patients with PD-L1 High tumors until the date of death

Other Outcome Measures:
Adverse events (AEs) [ Time Frame: up to approximately 72 months ]
To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC

Inclution 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 and has been deemed suitable for definitive chemoradiation therapy.
Patients with at least 1 lesion that qualifies as a RECIST 1.1 Target Lesion at baseline.
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, including but not limited to, chemotherapy and/or radiation therapy, immunotherapy, and investigational agents.
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.

The Estimated Number of Participants

Taiwan

80 participants
Global

600 participants