临床试验/NCT03430843

NCT03430843已完成3 期

A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

BeiGene137 个研究点分布在 3 个国家目标入组 512 人开始时间: 2018年1月26日最近更新: 2024年10月26日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 512
试验地点: 137
主要终点: Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

The purpose of this study was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or after first line therapy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
•Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
•At least one measurable/evaluable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization

排除标准

•Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
•History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
•Tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
•Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
•Received prior therapies targeting programmed death 1 (PD-1) or programmed death ligand 1 (PD-L1)
•Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
•Active brain or leptomeningeal metastasis.
•Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
•Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
•Known history of Human Immunodeficiency Virus (HIV)
•Has cardiovascular risk factors
•Pregnant or breastfeeding woman.
•NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

研究组 & 干预措施

Tislelizumab

Experimental

Tislelizumab on Day 1, given every 21 days

干预措施: Tislelizumab (Drug)

Investigator chosen chemotherapy (ICC)

Active Comparator

Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days

干预措施: Paclitaxel (Drug)

Investigator chosen chemotherapy (ICC)

Active Comparator

Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days

干预措施: Docetaxel (Drug)

Investigator chosen chemotherapy (ICC)

Active Comparator

Paclitaxel on Day 1, given every 21 days or on a weekly schedule; OR Docetaxel on Day 1, given every 21 days; OR Irinotecan on Days 1 and 8, given every 21 days

干预措施: Irinotecan (Drug)

结局指标

主要结局

Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set

时间窗: Approximately 2 years and 10 months from date of first randomization

OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants

次要结局

Overall Survival (OS) in the PDL-1 Positive Analysis Set(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
Objective Response Rate (ORR) in the ITT Analysis Set(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
Duration of Response (DOR) in the ITT Analysis Set(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set(Baseline to Cycle 6 (21 days per cycle))
Number of Participants Experiencing Adverse Events (AEs)(From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 months)
Progression-free Survival (PFS) in the ITT Analysis Set(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.(Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years))
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set(Baseline to Cycle 6 (21 days per cycle))
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set(Baseline to Cycle 6 (21 days per cycle))
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.(Baseline to Cycle 6 (21 days per cycle))
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set(Baseline to Cycle 6 (21 days per cycle))
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set(Baseline to Cycle 6 (21 days per cycle))

研究者

发起方

BeiGene

申办方类型

Industry

责任方

Sponsor

研究点 (137)

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