2025-523085-24-00招募中3 期
Phase III, Randomized, Open-label, Global, Multicenter Study of Rilvegostomig or Durvalumab in Combination With Chemotherapy as a First-line Treatment for Patients With Advanced Biliary Tract Cancer (ARTEMIDE-Biliary02).
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 232
- 试验地点
- 46
- 主要终点
- Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy
研究概览
简要总结
To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to durvalumab plus chemotherapy by assessment of Overall Survival (OS) in the PD-L1 ≥ 1% population.
研究设计
- 分配方式
- Randomized
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed adenocarcinoma of the biliary tract, including intra-hepatic or extra-hepatic cholangiocarcinoma (CCA) and gallbladder carcinoma (GBC).
- •Unresectable locally advanced or metastatic BTC, previously untreated in the advanced disease setting.
- •Known PD-L1 status assessed at a central laboratory using an acceptable tumor sample.
- •Measurable disease by RECIST 1.1 criteria using CT or MRI and is suitable for accurate repeated measurements.
- •ECOG Performance Status of 0 or 1 with no deterioration (ie, ECOG PS > 1) over the previous 2 weeks prior to baseline at screening and prior to randomization.
- •Adequate bone marrow and organ function.
排除标准
- •Ampullary carcinoma.
- •Any prior systemic therapy received for unresectable locally advanced or metastatic BTC.
- •Any prior exposure to any therapy targeting immune-regulatory receptors or mechanisms.
- •Any concurrent chemotherapy, radiotherapy, immunotherapy, investigational, biologic, or hormonal therapy for cancer treatment other than those under investigation in this study.
- •Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- •Active or ongoing interstitial lung disease/pneumonitis (of any grade), serious chronic gastrointestinal conditions associated with diarrhea, or active non-infectious skin disease (including any grade rash, urticaria, dermatitis, ulceration, or psoriasis) requiring systemic treatment.
研究组 & 干预措施
MYCOPHENOLATE MOFETIL
Auxiliary
干预措施: MYCOPHENOLATE MOFETIL (Drug)
INFLIXIMAB
Auxiliary
干预措施: INFLIXIMAB (Drug)
Rilvegostomig
Test
干预措施: Rilvegostomig (Drug)
IMFINZI 50 mg/mL concentrate for solution for infusion
Comparator
干预措施: IMFINZI 50 mg/mL concentrate for solution for infusion (Drug)
GEMCITABINE
Comparator
干预措施: GEMCITABINE (Drug)
CISPLATIN
Comparator
干预措施: CISPLATIN (Drug)
结局指标
主要结局
Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy
Overall survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy
次要结局
- Progression Free Survival of Rilvegostomig+Chemotherapy vs Durvalumab+Chemotherapy
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (46)
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