NCT07691762尚未招募3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 690
- 试验地点
- 3
- 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
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
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
Experimental
SHR-8068 + Adebrelimab + Bevacizumab + Transarterial Chemoembolization (TACE)
干预措施: SHR-8068 + Adebrelimab + Bevacizumab (Drug)
Treatment group B
Active Comparator
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
Experimental
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.
Progression-free survival (PFS) assessed by investigator
时间窗: Until progression, assessed up to approximately 2 years
次要结局
- Progression-free survival (PFS) assessed by Blinded Independent Review Committee (BIRC)(Until progression, assessed up to approximately 2 years.)
- Overall survival (OS)(Until study completion, assessed up to approximately 2 years.)
- 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 2 years.)
- Serious adverse events (SAEs)(Until study completion, assessed up to approximately 3 years.)
- Pharmacokinetics parameters of SHR-8068 and Adebrelimab: serum concentration(Approximately 90 days post-last dose.)
- Immunogenicity indicators of SHR-8068 and Adebrelimab: drug resistant antibody (ADA) and neutralizing antibody (NAb)(Approximately 90 days post-last dose.)
- 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)
研究者
研究点 (3)
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标识符
- NCT 编号
- NCT07691762
- 其他研究编号
- SHR-8068-305
日期
- 首次提交
- (3个月前)
- 首次发布
- (2个月前)
- 主要完成日期
- (4年后)
- 研究完成日期
- (4年后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否
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