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:
适应症
干预措施
相关药物
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
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
研究点 (137)
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相关资讯
Onco360 Selected as National Pharmacy Partner for Tevimbra in ESCC Treatment- Onco360 has been chosen as the exclusive national specialty pharmacy partner for BeiGene's Tevimbra (tislelizumab) for esophageal squamous cell carcinoma (ESCC).
- Tevimbra, a PD-1 inhibitor, received FDA approval for ESCC treatment after prior systemic chemotherapy, based on the RATIONALE-302 trial results.
- The RATIONALE-302 trial demonstrated a statistically significant improvement in overall survival for patients treated with Tevimbra compared to chemotherapy.
- Onco360 is committed to providing high-quality service to patients, caregivers, and providers, ensuring access to this new treatment option.last yearTislelizumab Approved in Israel for Advanced Esophageal Squamous Cell Carcinoma- The Israeli Ministry of Health has approved tislelizumab (Tevimbra) as monotherapy for unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after prior systemic chemotherapy.
- Approval was based on the phase 3 RATIONALE 302 trial, which demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy.
- In the RATIONALE-302 trial, tislelizumab showed a median OS of 8.6 months versus 6.3 months with chemotherapy, with a hazard ratio of 0.70 (P = .0001).
- This approval marks a significant step in providing a new treatment option for ESCC patients in Israel, potentially improving outcomes for this challenging malignancy.2 years ago