2023-507405-34-00进行中（未招募）3 期
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multi-Regional, International Study of Durvalumab in Combination with Gemcitabine plus Cisplatin versus Placebo in Combination with Gemcitabine plus Cisplatin for Patients with First-Line Advanced Biliary Tract Cancers (TOPAZ-1)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 14
- 主要终点
- Overall survival
研究概览
简要总结
To assess the efficacy of Arm A compared to Arm B in terms of OS in patients with first-line advanced BTC
研究设计
- 分配方式
- Randomized
- 主要目的
- Na
- 盲法
- Double (Monitor, Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed, unresectable advanced or metastatic biliary tract, including cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.
- •Previously untreated disease if unresectable or metastatic at initial diagnosis
- •Recurrent disease >6 months after curative surgery or >6 months after the completion of adjuvant therapy (chemotherapy and/or radiation)
- •WHO/ECOG PS of 0 or 1
排除标准
- •History of another primary malignancy
- •Brain metastases or spinal cord compression
- •Uncontrolled intercurrent illness
- •Major surgical procedure within 28 days prior to the first dose of IP.
- •Prior locoregional therapy such as radioembolization
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Progression-free survival (PFS), ORR (Objective response rate) , and Duration of response (DoR) according to RECIST 1.1using Investigator assessments
- ORR and DoR according to RECIST 1.1 using BICR assessments
- EORTC QLQ-C30: Global health status/QoL and impacts (eg, physical function); multi-term symptoms (eg, fatigue); and single items (eg, appetite loss, insomnia). EORTC QLQ-BIL21: Single-item symptoms (eg, abdominal pain [item 42], pruritus [item 36], jaundice [item 35])
- Association of PD-L1 expression level with PFS, ORR, DoR, and DCR (Disease control rate) according to RECIST 1.1 using Investigator assessments and OS (Overall survival)
- Serum concentration of durvalumab (peak and trough concentrations)
- Presence of ADAs for durvalumab (confirmatory results: positive or negative)
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (14)
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