NCT07682272尚未招募2 期
A Randomized, Open-label, Multicenter Phase II Study of SHR-8068 Combined With Adebrelimab and Apatinib for Perioperative Treatment in Resectable Hepatocellular Carcinoma With Intermediate or High Recurrence Risk
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Major pathological response (MPR (70%)) rate.
研究概览
简要总结
This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who voluntarily participate in this study and sign the informed consent form.
- •Age from 18 to 70, male or female.
- •Histopathologically/cytologically confirmed or clinically diagnosed with hepatocellular carcinoma (HCC).
- •At least one measurable lesion based on RECIST v1.
- •No prior systemic antitumor therapy for HCC.
- •ECOG Performance Status (PS) score of 0-
- •Child-Pugh liver function class A.
- •Expected survival at least 3 months.
- •Adequate organ function.
- •Blood pregnancy negative (women of childbearing age) and non-breastfeeding, effective contraception.
排除标准
- •Known intrahepatic cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, mixed hepatocellular carcinoma, or fibrolamellar hepatocellular carcinoma.
- •Other malignancies within the past 5 years or concurrent malignancy.
- •Known history of severe hypersensitivity reaction to any monoclonal antibody.
- •Previous or current central nervous system metastases.
- •Clinically symptomatic moderate or severe ascites requiring therapeutic paracentesis or drainage.
- •Hypertension that cannot be well controlled with antihypertensive medication.
- •Poorly controlled cardiac symptoms or heart disease.
- •Known hereditary or acquired bleeding disorders (e.g., coagulopathy) or thrombotic tendency.
- •Arterial thrombotic or embolic events within 6 months before enrollment.
- •Any other condition that, in the investigator's judgment, may affect the study results or lead to premature termination of the study.
研究组 & 干预措施
Adebrelimab + Apatinib Group
Active Comparator
Adebrelimab, Apatinib.
干预措施: Adebrelimab Injection (Drug)
Adebrelimab + Apatinib Group
Active Comparator
Adebrelimab, Apatinib.
干预措施: Apatinib Mesylate Tablets (Drug)
SHR-8068 + Adebrelimab + Apatinib Group
Experimental
SHR-8068, Adebrelimab, Apatinib.
干预措施: Adebrelimab Injection (Drug)
SHR-8068 + Adebrelimab + Apatinib Group
Experimental
SHR-8068, Adebrelimab, Apatinib.
干预措施: Apatinib Mesylate Tablets (Drug)
结局指标
主要结局
Major pathological response (MPR (70%)) rate.
时间窗: After surgery, approximately 3 months.
MPR (70%) is defined as residual viable tumor cells \<= 30% in the tumor bed.
次要结局
- Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.(Approximately 2 years.)
- Event-free survival (EFS).(From randomization to event, approximately 2 years.)
- 12-month and 24-month Event-free survival (EFS) rate.(From randomization to event, approximately 2 years.)
- R0 resection rate.(After surgery, approximately 3 months.)
- Safety endpoints, including surgical complications by Clavien-Dindo.(Approximately 2 years.)
研究者
研究点 (1)
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