NCT06360042招募中2 期
Anti-PD-1/PD-L1 Combined With Anti-angiogenic Agents as First-line Therapy for Unresectable Hepatocellular Carcinoma: a Multicenter, Randomized, Open-label Trial
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- 12-month overall survival rate
研究概览
简要总结
This is a multicenter, randomized, open-label clinical study to evaluate the efficacy and safety of Adebrelimab plus Apatinib (cohort 1), or Adebrelimab plus Bevacizumab (cohort 2), or Camrelizumab plus Apatinib (cohort 3) as first-line treatment of unresectable HCC.
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
- •Locally advanced or metastatic and/or unresectable Hepatocellular Carcinoma (HCC)
- •No prior systemic therapy for HCC. Previous use of herbal therapies/traditional Chinese medicines with anti-cancer activity included in the label is allowed.
- •BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy
- •At least one measurable lesion per RECIST v1.1
- •ECOG Performance Status of 0 or 1
- •Child-Pugh class of A5 to B7
- •Adequate organ function
排除标准
- •Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously
- •Moderate-to-severe ascites with clinical symptoms
- •History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment
- •Known genetic or acquired hemorrhage or thrombotic tendency
- •Thrombosis or thromboembolic event within 6 months prior to the start of study treatment
- •Hypertension that can not be well controlled through antihypertensive drugs Factors to affect oral administration
- •History of hepatic encephalopathy
- •Previous or current presence of metastasis to central nervous system
研究组 & 干预措施
1
Experimental
Adebrelimab（1200mg iv q3w） plus Apatinib(250mg po qd)
干预措施: Adebrelimab plus Apatinib (Drug)
2
Experimental
Adebrelimab（1200mg iv q3w）plus Bevacizumab(15mg/kg iv q3w)
干预措施: Adebrelimab plus Bevacizumab (Drug)
3
Experimental
Camrelizumab (200mg iv q2w) plus Apatinib(250mg po qd)
干预措施: Camrelizumab plus Apatinib (Drug)
结局指标
主要结局
12-month overall survival rate
时间窗: Up to approximately 3 years
次要结局
- TTR(Up to approximately 3 years)
- ORR(Up to approximately 3 years)
- DCR(Up to approximately 3 years)
- DoR(Up to approximately 3 years)
- TTP(Up to approximately 3 years)
- PFS(Up to approximately 3 years)
- OS(Up to approximately 3 years)
- safety according to NCI Common Terminology Criteria for Adverse Events, version 5.0.(Up to approximately 3 years)
研究者
研究点 (1)
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