A Randomized, Open-label, Controlled, Multicenter Phase III Clinical Study to Compare the Effectiveness and Safety of IBI310 Combined With Sintilimab Versus Sorafenib in the First-line Treatment of Advanced Hepatocellular Carcinoma

Innovent Biologics (Suzhou) Co. Ltd.1 个研究点分布在 1 个国家目标入组 344 人2021年2月7日

适应症Hepatocellular Carcinoma

干预措施IBI310 Sintilimab Sorafenib

概览

阶段: 3 期
干预措施: IBI310
疾病 / 适应症: Hepatocellular Carcinoma
发起方: Innovent Biologics (Suzhou) Co. Ltd.
入组人数: 344
试验地点: 1
主要终点: Overall survival (OS)
状态: 已完成
最后更新: 上个月

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have had progressive disease after surgical resection or local treatment.

注册库

clinicaltrials.gov

开始日期

2021年2月7日

结束日期

2025年12月31日

最后更新

上个月

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Innovent Biologics (Suzhou) Co. Ltd.

责任方

Sponsor

入排标准

入选标准

•Histologically/cytologically confirmed hepatocellular carcinoma, or liver cirrhosis meeting the clinical diagnostic criteria;
•ECOG performance status score of 0 or 1 point;
•No systemic antitumor treatment for hepatocellular carcinoma before the first administration;
•Barcelona Clinic Liver Cancer stage C, or Stage B not suitable for radical surgery and/or local treatment;
•At least 1 measurable lesion according to RECIST V1.1);
•Child-Pugh:≤6
•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 combined with IBI310

干预措施: IBI310

Sintilimab combined with IBI310

干预措施: Sintilimab

Sorafenib

干预措施: Sorafenib

结局指标

主要结局

Overall survival (OS)

时间窗: up to 24 months after randomization

Objective response rate (ORR)

时间窗: up to 24 months after randomization

Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC

次要结局

Duration of response(DOR)(up to 24 months after randomization)
Disease control rate(DCR)(up to 24 months after randomization)
Time to response(TTR)(up to 24 months after randomization)
The incidence and severity of Treatment-Emergent Adverse Events(up to 24 months after randomization)
Time to progression(TTP)(up to 24 months after randomization)
Progression-free survival (PFS)(up to 24 months after randomization)