A Phase III, Randomized, Double-blind, Multicenter Study of SHR-8068 and Adebrelimab Plus Bevacizumab in Combination With TACE in Participants With Incurable Hepatocellular Carcinoma
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 690
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS) assessed by investigator
研究概览
简要总结
This is a multicenter, Phase 3 clinical trial to evaluate the efficacy and safety of SHR-8068, Adebrelimab, and Bevacizumab and TACE versus Placebo with TACE in incurable hepatocellular carcinoma.
Participants will continue treatment until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years old, male or female;
- •Diagnosis confirmed HCC by pathologically or clinically;
- •At least one measurable lesion;
- •Child-Pugh liver function grade A;
- •ECOG-PS score: 0 or 1;
- •Eligible for TACE treatment as assessed by the investigator;
- •Participants with HBV or HCV infection must be on and remain on standard antiviral therapy throughout the study period;
- •Consent to contraception
排除标准
- •Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma; Participants with other malignancies currently or within the past 5 years;
- •Participants with any active, known or suspected autoimmune disorder;
- •Participants with hypertension which cannot be well controlled by antihypertensives;
- •Uncontrolled cardiac diseases or symptoms;
- •Participants with hepatic encephalopathy;
- •Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
- •History of gastrointestinal perforation and/or fistula,
- •Participants with other potential factors that may affect the study results.
研究组 & 干预措施
Treatment group A
SHR-8068+ Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)
干预措施: SHR-8068+ Adebrelimab+ Bevacizumab (Drug)
Treatment group B
SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo+Transarterial Chemoembolization(TACE)
干预措施: SHR-8068 Placebo+ Adebrelimab Placebo+ Bevacizumab Placebo (Drug)
Treatment group C
SHR-8068 Placebo+Adebrelimab+ Bevacizumab +Transarterial Chemoembolization(TACE)
干预措施: SHR-8068 Placebo +Adebrelimab+ Bevacizumab (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by investigator
时间窗: Until progression, assessed up to approximately 2 years
次要结局
- Objective response rate (ORR)(Until study completion,assessed up to approximately 2 years)
- Disease control rate (DCR)(Until study completion,assessed up to approximately 2 years)
- Duration of objective tumor response (DoR)(Until study completion,assessed up to approximately 2 years)
- Adverse events (AEs)(Until study completion,assessed up to approximately 2years)
- Progression-free survival (PFS) assessed by Blinded Independ Review Committee( BIRC)(Until progression, assessed up to approximately 2 years)
- Overall survival (OS)(Until study completion, assessed up to approximately 2 years)
- Serious adverse events (SAEs)(Until study completion,assessed up to approximately 3 years)
- Pharmacokinetics parameters of SHR-8068 、Adebrelimab:serum concentration(Approximately 90 days post-last dose)
- Immunogenicity indicators of SHR-8068 、Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)(Approximately 90 days post-last dose)