Donafenib Combined with Sintilimab for Advanced HCC: a Single-arm, Single-center, Prospective Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
研究概览
简要总结
This study will evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced hepatocellullar carcinoma (HCC).
详细描述
This is a Phase II study to evaluate the efficacy and safety of donafenib combined with sintilimab in patients with advanced HCC.
30 subjects with advanced HCC (Barcelona-Clinic- Liver-Cancer [BCLC] stage C, or China liver cancer staging [CNLC] IIIa/IIIb) will be enrolled in the study.
Part 1 (Safety Run-in): 6 patients will receive donafenib 200mg P.O. BID and sintilimab 200mg I.V. for a 21-day cycle.
Part 2: patients will receive donafenib at the recommended phase 2 dose determined from Part 1 and sintilimab 200mg I.V. Q3W.
Donafenib will last 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. Sintilimab will last up to 24 months, or 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. Patients will be allowed to have donafenib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced HCC (BCLC stage C or CNLC IIIa/IIIb ) with diagnosis confirmed by histology/cytology or clinically
- •Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included
- •Patients who previously received local treatment, such as transcatheter arterial chemoembolization, transcatheter arterial embolization and radiotherapy, are allowed to be included
- •At least one measurable lesion
- •Child-Pugh score ≤7
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Adequate organ and hematologic function
- •Life expectancy of at least 3 months
排除标准
- •Diffuse HCC
- •Macrovascular invasion involving the main trunk or inferior vena cava
- •Central nervous system metastasis
- •History of malignancy other than HCC
- •Esophageal and/or gastric varices bleeding within 3 months prior to initiation of study treatment
- •Uncontrolled ascites
- •History of hepatic encephalopathy
- •Patients who received prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or hepatic arterial infusion chemotherapy (HAIC) for HCC
- •History of organ and cell transplantation
- •Active severe infection; use of antibiotics within 2 weeks prior to injection of sintilimab
- •Autoimmune disease or immune deficiency
- •Severe organ (heart, kidney) dysfunction
研究组 & 干预措施
Donafenib+sintilimab
Donafenib combined with sitilimab.
干预措施: Donafenib+sintilimab (Drug)
结局指标
主要结局
Progression free survival (PFS) assessed by investigators according to modified Response Evalutaion Criteria in Solid Tumors (mRECIST).
时间窗: 18 months
The time from initiation of treatment until the first occurrence of disease progression or death from any cause, whichever occurs first.
次要结局
- Objective response rate (ORR) assessed by investigators according to mRECIST.(18 months)
- PFS assessed by investigators according to Response Evalutaion Criteria in Solid Tumors (RECIST) v1.1(18 months)
- DCR assessed by investigators according to RECIST 1.1.(18 months)
- Adverse Events (AEs)(18 months)
- ORR assessed by investigators according to RECIST 1.1.(18 months)
- Disease control rate (DCR) assessed by investigators according to mRECIST.(18 months)