NCT04989816已完成2 期
A Single-arm Study of Trastuzumab Deruxtecan (T-DXd) Monotherapy for Patients With HER2-expressing Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma Who Have Received 2 or More Prior Regimens (DESTINY-Gastric06)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
研究概览
简要总结
This is a Phase II, open-label, single-arm, multicentre, study in China assessing the efficacy and safety of T-DXd in participants with HER2-expressing advanced gastric or GEJ adenocarcinoma who have received at least 2 prior regimens including a fluoropyrimidine agent and a platinum agent
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Male or female ≥ 18 years of age
- •Pathologically documented gastric or GEJ adenocarcinoma
- •Disease progression on or after ≥ 2 prior platinum and fluoropyrimidine agents for advanced/metastatic disease
- •ECOG PS 0-1
- •Willing and able to provide an adequate newly-acquired tumour sample for confirmation of HER2 status
排除标准
- •Pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and CART. Drainage and CART.
- •Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids
- •Active primary immunodeficiency, known HIV, active HBV, HCV infection.
- •Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- •History of non-infectious pneumonitis/ILD, current ILD, or where suspected ILD that cannot be ruled out by imaging at screening.
- •Lung-specific intercurrent clinically significant severe illnesses.
研究组 & 干预措施
T-DXd arm
Experimental
T-DXd monotherapy
干预措施: Trastuzumab Deruxtecan (Drug)
结局指标
主要结局
Confirmed Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
时间窗: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months
Confirmed ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by ICR per RECIST 1.1.
Best Objective Response Rate by RECIST 1.1 Based on Independent Central Review (ICR)
时间窗: Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 19.3 months
The best response based on the overall visit responses from each RECIST 1.1 assessment or the last evaluable assessment in the absence of RECIST 1.1 progression
次要结局
- Progression-free Survival (PFS) Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months)
- Progression-free Survival (PFS) Rate at 3 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 3 months using the Kaplan-Meier technique)
- Progression-free Survival (PFS) Rate at 6 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 6 months using the Kaplan-Meier technique)
- Progression-free Survival (PFS) Rate at 9 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 9 months using the Kaplan-Meier technique)
- Progression-free Survival (PFS) Rate at 12 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 12 months using the Kaplan-Meier technique)
- Progression-free Survival (PFS) Rate at 15 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 15 months using the Kaplan-Meier technique)
- Progression-free Survival (PFS) Rate at 18 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 18 months using the Kaplan-Meier technique)
- Progression-free Survival (PFS) Rate at 21 Months Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Calculated at 21 months using the Kaplan-Meier technique)
- Disease Control Rate (DCR) Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months)
- Disease Control Rate (DCR) Based on Independent Central Review (ICR) at Week 12(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. DCR assessed at Week 12)
- Duration of Response (DoR) Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months)
- Overall Survival (OS) Based on Independent Central Review (ICR)(From date of enrolment until death due to any cause. Assessed up to approximately 30 months (from date of first subject in to data cut-off 28February2024))
- Best Percentage Change in Sum of Diameters of Measurable Tumours Based on Independent Central Review (ICR)(Tumour assessments every 6 weeks from 1st dose of treatment until Recist 1.1 defined radiological progressive disease. Assessed up to a maximum of 22 months)
研究者
研究点 (1)
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