2024-518210-81-00招募中3 期
A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicenter Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 273
- 试验地点
- 49
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To demonstrate the efficacy of rilvegostomig in combination with tremelimumab and bevacizumab (Arm A) relative to atezolizumab and bevacizumab (Arm C) by assessment of OS in participants with advanced HCC
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Post-intervention
- 盲法
- None
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
- 是
入选标准
- •Locally advanced or metastatic and/or unresectable HCC
- •WHO/ECOG performance status of 0 or 1
- •BCLC stage B (that is not eligible for locoregional therapy) or stage C. Child-Pugh Score class A
- •At least one measurable target lesion
- •Co-infected with HBV and HCV are not eligible
- •Adequate organ and bone marrow function measured during the screening period
- •Must not have received prior systemic therapy for intermediate, advanced, or metastatic HCC.
- •Disease that is not amenable to curative surgical and/or locoregional therapies. Participants who have received approved adjuvant therapy (including immune checkpoint inhibitor treatment) must have a minimum interval of 6 months between the completion of such therapy and the documented diagnosis of recurrent or metastatic disease. For participants who received locoregional therapy for HCC, locoregional therapy must have been completed ≥ 28 days prior to the baseline scan for the current study.
排除标准
- •Any evidence of uncontrolled intercurrent diseases
- •Bleeding or other risks. HCC related - Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
- •Bleeding or other risks. HCC related - Central nervous system metastases or spinal cord compression (including asymptomatic and adequately treated disease)
- •Bleeding or other risks. HCC related - Prior treatment with anti-CTLA-4 and/or anti-TIGIT.
- •Bleeding or other risks. HCC related - Radiotherapy within 28 days and abdominal/ pelvic radiotherapy within 60 days prior to initiation of study treatment, except palliative radiotherapy to bone lesions within 7 days prior to initiation of study treatment
- •Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment
- •History of another primary malignancy
- •Persistent toxicities caused by previous anti-cancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline
- •Clinically meaningful ascites, pleural effusion, or pericardial effusion requiring non-pharmacologic intervention to maintain symptomatic control within 6 months prior to the first scheduled dose.
- •History of active primary immunodeficiency or active infection
- •History of hepatic encephalopathy
- •Current or recent (within 10 days of first dose of study treatment) use of aspirin (≥ 325 mg/day) or treatment with dipyridamole, ticlopidine, clopidogrel, and cilostazol
- •Current or recent (within 10 days prior to study treatment start) use of full-dose oral or parenteral anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylactic) purposes is ineligible
结局指标
主要结局
Overall Survival (OS)
Overall Survival (OS)
次要结局
- PFS, ORR, DoR by BICR per RECIST v1.1
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (49)
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