NCT06739317尚未招募2 期
•Stereotactic Body Radiotherapy Combined with Camrelizumab and Apatinib As Conversion Therapy Versus Camrelizumab Combined with Apatinib As First-Line Therapy for Unresectable Hepatocellular Carcinoma: a Prospective, Multicenter, Open-label, Randomized Controlled Clinical Trial.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2025年1月1日最近更新:
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
- 发起方
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
•This is a randomized, open-label, multi-center, phases 2 and phase 3 trial to evaluate the efficacy and safety of SBRT combined with Camrelizumab and Apatinib as conversion therapy versus Camrelizumab combined with Apatinib as first-Line therapy for unresectable hepatocellular carcinoma.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent Form (ICF).
- •Aged 18 years or older.
- •Hepatocellular carcinoma confirmed by histology/cytology. Cirrhosis meets the clinical diagnostic criteria for hepatocellular carcinoma of the American Association for the Diagnosis of Liver Diseases (AASLD).
- •Barcelona Clinic Liver Cancer stage B or C disease, which was not amenable to radical surgery.
- •ECOG Performance Status of 0 or
- •Child-Pugh class of A.
排除标准
- •Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously.
- •Existence of active autoimmune disease or history of autoimmune disease and may relapse.
- •Patients with innate or acquired immune deficiency (e.g., HIV infection).
- •Known allergies to study drugs or excipients.
研究组 & 干预措施
Experimental group
Experimental
干预措施: Radiation (Radiation)
Experimental group
Experimental
干预措施: First line therapy (Drug)
Experimental group
Experimental
干预措施: operation (Procedure)
control group
Active Comparator
干预措施: First line therapy (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to approximately 3 years
The primary endpoint of phase 3 study is OS
The R0 Resection rate of the experimental group
时间窗: Up to approximately 30 days
The primary endpoint of phase 2 study is the R0 Resection rate of the experimental group
次要结局
- Objective Response Rate (ORR)(Up to approximately 3 years)
- Disease control rate (DCR)(Up to approximately 3 years.)
- Time to Response (TTR)(Up to approximately 3 years.)
- Duration of response (DoR)(Up to approximately 3 years.)
- Time to progression (TTP)(Up to approximately 3 years.)
- Event free survival (EFS)(Up to approximately 3 years.)
- Conversion rate(Up to approximately 30 days.)
- Resection rate(Up to approximately 30 days.)
- R0 resection rate(Up to approximately 30 days.)
- Pathologic complete response (pCR) rate(Up to approximately 30 days.)
- Major pathological response (MPR)(Up to approximately 30 days.)
- Safety(Up to approximately 90 days.)
研究者
Ming Kuang
Professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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