NCT05010434进行中（未招募）2 期
Sintilimab and Bevacizumab Combined With Radiotherapy in the Treatment of Advanced Hepatocellular Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2021年8月16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
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- ORR (objective response rate)
研究概览
简要总结
The purpose of this study is to investigate both the efficacy and safety of sintilimab combined with bevacizumab and radiotherapy in advanced hepatocellular carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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;
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •Treatment-naïve primary HCC (consistent with the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis (18)) or initial recurrent HCC after radical resection without any postoperative anti-cancer treatment;
- •At least one measurable lesion in the liver on the basis of modified Response Evaluation Criteria in Solid Tumors (mRECIST);
- •Presented with Cheng's type I/II/III PVTT;
- •Largest tumor size ≤ 10 cm, number of tumors ≤ 3, and remnant liver volume ≥ 50%;
- •Child-Pugh class A;
- •Adequate hematological, liver, renal function:
- •hemoglobin concentration ≥ 90 g/L;
- •neutrophil count ≥ 1.5×109/L;
- •platelet count ≥ 60×109/L;
- •AST and ALT ≤ 3×upper limit of normal (ULN)
- •total bilirubin ≤ 1.5×ULN;
- •serum creatinine ≤ 1.5×ULN;
- •serum albumin concentration ≥ 30 g/L;
- •Life expectancy of at least 3 months.
排除标准
- •Tumor invasion of the superior mesenteric vein or bile ducts;
- •Infiltrative HCC;
- •Allergic to research reagents;
- •With other malignancies within 5 years;
- •With poorly controlled hypertension;
- •A past medical history of hepatic decompensation, such as hepatic encephalopathy, refractory ascites, and esophageal or gastric variceal bleeding;
- •A history of autoimmune disease;
- •Active infection requiring systemic treatments;
- •Severe bleeding;
- •With diseases needing daily non-steroidal anti-inflammatory drug (NSAID) therapy;
- •With other severe comorbidities.
研究组 & 干预措施
Sintilimab and Bevacizumab Combined with Radiotherapy
Experimental
干预措施: Sintilimab and Bevacizumab Combined with Radiotherapy (Drug)
结局指标
主要结局
ORR (objective response rate)
时间窗: through study completion, up to 2 year
the proportion of patients who have a partial or complete response to therapy.
次要结局
- LCR (local control rate)(through study completion, up to 2 year)
- OS (overall survival)(through study completion, up to 2 year)
- DCR (disease control rate)(through study completion, up to 2 year)
- PFS (progression-free survival)(through study completion, up to 2 year)
- Adverse effects(through study completion, up to 2 year)
研究者
Zhen-Wei Peng
Associate Professor
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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