NCT03794440Unknown2 期
A Randomized, Open-label，Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Sintilimab and IBI305 Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma. （ORIENT-32）
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 595
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.
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
- •Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
- •ECOG performance status between 0 and 1
- •No systematic anti-tumor treatment has been performed.(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
- •Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
- •At least 1 lesion with measurable disease at baseline by RECIST V1.
- •Child-Pugh: <=7
- •Adequate organ and bone marrow function.
排除标准
- •With fibrous lamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma components in tumor tissues.
- •Have a history of hepatic encephalopathy or have a history of liver transplantation.
- •With clinical symptoms requires drainage of pleural effusion, ascites or pericardial effusion.
- •Central nervous system (CNS) metastasis.
- •Uncontrolled high blood pressure, systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg after optimal medical treatment.
- •Local treatment for liver lesions within 4 weeks.
研究组 & 干预措施
Sintilimab +IBI305
Experimental
干预措施: Sintilimab (Drug)
Sintilimab +IBI305
Experimental
干预措施: IBI305 (Drug)
Sorafenib
Active Comparator
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 24 months after randomization
Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC.
Overall survival (OS)
时间窗: up to 24 months after randomization
次要结局
- EORTC QLQ-C30(up to 24 months after randomization)
- PFS(up to 24 months after randomization)
- Objective response rate (ORR)(up to 24 months after randomization)
- Disease control rate (DCR)(up to 24 months after randomization)
- Duration of response (DOR)(up to 24 months after randomization)
- Time to progression (TTP)(up to 24 months after randomization)
- Time to response (TTR)(up to 24 months after randomization)
- Anti-drug antibody (ADA)(up to 24 months after randomization)
- EORTC QLQ-HCC18(up to 24 months after randomization)
研究者
研究点 (1)
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