An Open-label, Multicenter Phase Ib/II Clinical Study of SHR-8068 Combined With Adebrelimab and Bevacizumab in the Treatment of Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Dose Limiting Toxicity
研究概览
简要总结
To evaluate the tolerability and safety of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced HCC; To evaluate the efficacy of SHR-8068 in combination with Adebrelimab and Bevacizumab in subjects with advanced 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 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, both male and female;
- •Stage 1: pathologically diagnosed, incurable advanced HCC subjects who have failed standard treatment or were unwilling to accept standard treatment;
- •Stage 2: pathologically diagnosed, incurable advanced HCC subjects, who have no prior immunotherapy, no more than 1 line of previous system treatment;
- •At least one measurable lesion based on RECIST v1.1 criteria;
- •Barcelona clinic liver cancer: Stage B or C;
- •ECOG PS score: 0-1 points;
- •Child-Pugh score: ≤ 7;
- •Expected survival period ≥ 3 months;
- •Adequate organ function.
排除标准
- •Fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma or mixed cholangiocarcinoma / hepatocellular carcinoma;
- •Patients with any active, known or suspected autoimmune disorder;
- •Systemic treatment with corticosteroids or other immunosuppressants within 1 month before the first dose;
- •With known severe allergic reactions to any other monoclonal antibodies;
- •Patients with known CNS metastasis or hepatic encephalopathy;
- •Patients with liver tumor burden greater than 50% of total liver in volume, or patients who have previously undergone liver transplantation;
- •Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose;
- •Patients with other malignancies currently or within the past 5 years;
- •Patients with hypertension which cannot be well controlled by antihypertensives;
- •Uncontrolled cardiac diseases or symptoms;
- •Patients with other potential factors that may affect the study results.
研究组 & 干预措施
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1
干预措施: SHR-8068 (Drug)
Adebrelimab in combination with Bevacizumab
干预措施: Adebrelimab (Drug)
Adebrelimab in combination with Bevacizumab
干预措施: Bevacizumab (Drug)
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1
干预措施: Adebrelimab (Drug)
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D1
干预措施: Bevacizumab (Drug)
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2
干预措施: Adebrelimab (Drug)
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2
干预措施: Bevacizumab (Drug)
Adebrelimab in combination with Bevacizumab and SHR-8068 RP2D2
干预措施: SHR-8068 (Drug)
结局指标
主要结局
Dose Limiting Toxicity
时间窗: The observation period is 21 days after the first dose
Objective Response Rate
时间窗: At the time point of every 6 or 9 weeks, up to 2 years
determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points
Incidence and severity of grade ≥3 drug-related adverse events and serious adverse events of the two-drug or three-drug combination
时间窗: The observation period is from the time when all informed subjects signed the informed consent to the end of the safety follow-up period, up to 2 years
次要结局
- Disease Control Rate, determined using RECIST v1.1 criteria(At the time point of every 6 or 9 weeks, up to 2 years)
- Progression-Free-Survival assessed by investigator(up to 2 years])