NCT05262959已完成2 期
A Single Center Study of Donafenib Combined With Programmed Cell Death-1 （PD-1） + Transarterial Chemoembolization (TACE) in the First-line Treatment of Advanced Hepatocellular Carcinoma (aHCC)
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年12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
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Progression-free survival 1(PFS 1)
研究概览
简要总结
This study is expected to recruit 30 patients with unresectable HCC who will be treated with Donafenib combined with PD-1 + TACE. During the study period, the tumor efficacy and resectability will be evaluated by imaging examination every 6 weeks. Patients with successful transformation can choose hepatectomy or observation. During the study, safety evaluation and effectiveness evaluation will be carried out.
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
- •Patients voluntarily enter the study and sign informed consent form (ICF);
- •Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender;
- •Clinically or histologically diagnosed as unresectable HCC;
- •There is at least one measurable lesions that meet the mRECIST standard;
- •Child-pugh classification A or B (score≤7);
- •ECOG : 0 ~ 1 ;
- •The number of intrahepatic tumors ≤ 10 and the maximum tumor diameter ≤ 10cm;
- •Previous TACE treatment ≤ 1 time;
- •Life expectancy ≥ 3 months;
- •For patients with HBV infection, if HBV-DNA is≥10^4copies/ml within 14 days before enrollment, they should take antiviral treatment first, reduce 1 log or reduce to <10^4copies/ml before entering the study, and continue antiviral treatment and monitor liver function and serum HBV-DNA levels;
- •Baseline blood routine and biochemical indexes meet the following criteria within 14 days before treatment:
- •Blood routine examination criteria must be met: (no blood transfusion within 14 days)
- •ANC≥1.5×10^9/L；
- •PLT≥70×10^9/L.
- •Biochemical tests are subject to the following criteria:
- •BIL <1.25xULN ；
- •ALT and AST<5xULN；
- •Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance>50ml/min ( Cockcroft-Gault formula)；
- •Albumin≥28g/L；
- •Electrolytes (phosphorus, calcium, magnesium, potassium) ≥ LLN;
- •Urine protein <2+ or 24-hour urine protein quantitative detection ≤1.0 g/L.
- •Blood coagulation indexes are subject to the following criteria:
- •Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;
- •Activated partial thromboplastin time（APTT）≤1.5 × ULN.
- •The serum pregnancy test results of female patients with fertility (referring to premenopausal or non surgical sterilization) must be negative within 14 days before enrollment.
排除标准
- •Pathologically confirmed hepatocellular carcinoma intrahepatic cholangiocarcinoma (HCC-ICC) mixed or fibrolamellar hepatocellular carcinoma;
- •The presence of a tumor thrombus in the main portal vein, biliary tract tumor thrombus, inferior vena cava tumor thrombus, or extrahepatic metastasis;
- •Hepatocellular carcinoma recurrence within 2 years after radical resection or ablation;
- •History of malignancy other than HCC within 5 years;
- •Esophageal and/or gastric varices bleeding within 4 weeks prior to initiation of study treatment;
- •Presence of uncontrolled hepatic encephalopathy, hepatorenal syndrome, ascites, pleural effusion, or pericardial effusion;
- •Patients who received liver transplant surgery, prior systemic therapy (chemotherapy, targeted therapy or immunotherapy) or palliative local treatment ≥2 times for HCC；
- •History of organ and cell transplantation；
- •TACE contraindications identified by the investigator;
- •Active severe infection;
- •Autoimmune disease or immune deficiency;
- •Severe organ (heart, kidney) dysfunction;
- •Pregnant or breastfeeding women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
- •Unable to follow the research protocol for treatment or scheduled follow-up; Any other researcher who thinks they cannot be included.
研究组 & 干预措施
Donafenib
Experimental
Donafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib.
干预措施: TACE (Procedure)
Donafenib
Experimental
Donafenib: 0.1g po. BID. And it will be taken on the first day of the study. PD-1: 200mg ivgtt. Q3W. It will be used at the same time as Donafenib. TACE: The first treatment will be carried out 2-3 weeks after taking Donafenib.
干预措施: Donafenib, PD-1 (Drug)
结局指标
主要结局
Progression-free survival 1(PFS 1)
时间窗: an average of 1 year
PFS 1 refers to the time from the date of enrollment to the first documented tumor progression as assessed by mRECIST criteria or death from any cause.
次要结局
- Objective response rate (ORR) per mRECIST(an average of 1 year)
- Disease control rate (DCR) per mRECIST(an average of 1 year)
- Adverse events and serious adverse events.(an average of 1.5 year.)
- Overall survival (OS)(an average of 1.5 year)
研究者
研究点 (1)
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