NCT06310590已完成1 期
Study on the Safety and Effectiveness of NRT6003 Injection in Patients With Unresectable Hepatocellular Carcinoma (HCC)
Chengdu New Radiomedicine Technology Co. LTD.10 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年8月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 10
- 主要终点
- Adverse events/ Severe adverse events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and efficacy of NRT6003 Injection in patients with unresectable HCC.
详细描述
The efficacy and safety of TareSphere in patients with unresectable HCC remains unknown. This trial is a prospective, multicenter, open-label, single-arm phase I trial designed to evaluate the safety and efficacy of NRT6003 injection.
The primary objective is to evaluate the safety of NRT6003 Injection. While the secondary objectives include the assessments of the antitumoral efficacy, the improvement of patients´ quality of life, and the distribution characteristics of Yttrium-90 in body.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 80 and signed informed consent;
- •Diagnosed as hepatocellular carcinoma clinically, by imaging and/or pathology based on the guideline of the National Health Commission of the People's Republic of China (2022);
- •Evaluated by the investigator as not suitable for surgical resection/ablation, or there are other reasons unsuitable for surgical resection/ablation, or the participant refuses surgical resection/ablation;
- •At least one well defined tumor (mRECIST), assessed by enhanced MRI or CT images;
- •Child-Pugh score ≤ 7;
- •Eastern Cooperative Oncology Group performance status ≤ 1;
- •Tumor burden ≤ 50 percent of the total liver volume;
- •Adequate organ function: (1) Blood routine [no blood transfusion or granulocyte colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; platelet (PLT) ≥ 80 × 10^9/L; hemoglobin (HGB) ≥ 90 g/L; (2) Liver function: total bilirubin (TBIL) ≤ 2 times upper limit of normal (ULN); alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤
- •0×ULN; Albumin > 30 g/L; (3) Renal function: Creatinine (Cr) ≤ 1.5×ULN; creatinine clearance rate (CCr)≥ 50 mL/min (calculated according to Cockcroft-Gault formula); (4) Coagulation function: international normalized ratio (INR), prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN [If any participant takes warfarin or heparin for anticoagulation therapy, the investigator should evaluate whether the participant meet the requirements of the protocol]; (5) Cardiovascular function: left ventricular ejection fraction (LVEF) ≥ 50 percent assessed by ultrasonic cardiogram;
- •Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 months after the end of the trial. Men are forbidden to donate sperm. The pregnancy test results of female participants of childbearing age during the screening period and within 24 hours before administration must be negative.
排除标准
- •With the extrahepatic metastasis or concurrent malignant tumors other than liver cancer;
- •With the hepatic tumor thrombus (excluding the thrombus limited to liver segments or lobes);
- •With hepatic artery malformation and unable to intubate hepatic artery;
- •Allergy to contrast agents or anesthetics;
- •Severe pulmonary dysfunction (forced expiratory volume in one second, FEV1/FVC < 50 percent or forced expiratory volume in one second (FEV1) < 50 percent of predicted value, or maximum voluntary ventilation (MVV) < 50 L/min);
- •With the clinical manifestations of decompensated liver cirrhosis (moderate or severe ascites, upper gastrointestinal bleeding, hepatic encephalopathy, etc.);
- •With diseases have not been controlled despite aggressive treatment, and which may affect the safety or the efficacy of the investigational drug in the judgement of investigators;
- •Active or severely infected participants requiring systemic therapy;
- •With positive results of HIV antibody test;
- •Estimated survival period < 3 months;
- •Have received radiotherapy or transcatheter arterial chemoembolization (participants who have received transcatheter arterial non-iodized oil chemoembolization are judged by investigators);
- •Technetium (99mTc)-macroaggregated albumin (MAA) hepatic arterial perfusion imaging estimates that the NRT6003 injection cannot cover all lesions within the liver (excluding lesions previously treated by the investigator as non-active or non-progressive);
- •Hepatic artery angiography and 99mTc-MAA hepatic artery perfusion imaging demonstrate gastrointestinal shunts, which may not be remedied through vascular intervention techniques;
- •99mTc-MAA arterial perfusion imaging shows that the single lung radiation absorbed dose > 30 Gy;
- •Received antitumor therapy or participated in other interventional clinical trials within 30 days prior to dosing;
- •Pregnant or lactating women;
- •Have persistent, unrelieved toxicity reaction of CTCAE≥2 grade caused by previous antitumor treatment (excluding alopecia) judged by investigators;
- •Any other reason that the investigator deems the participant unsuitable for participating in this trial.
研究组 & 干预措施
NRT6003 Injection
Experimental
Patients will be administered a single dose of NRT6003 Injection, and then they will be assessed by SPECT-CT imaging within 24 hours for its distribution in the chest and upper abdomen, including extrahepatic shunts, intrahepatic distribution, and target lesion distribution as expected.
Nine Patients will be tested for the radioactivity of Yttrium-90 in blood, urine, and feces (if available).
干预措施: NRT6003 Injection (Drug)
结局指标
主要结局
Adverse events/ Severe adverse events
时间窗: Up to 12 months
Occurrence of adverse events/severe adverse events
Localized Objective response rates (ORR)
时间窗: Up to 6 months (initial tumor assessment after administration)
Liver target lesions, evaluated based on the mRECIST criteria
次要结局
- Hepatic time to progression (hTTP)(Up to 12 months)
- Duration of response (DOR)(Up to 12 months)
- Disease control rate (DCR)(Up to 12 months)
- Time to progression (TTP)(Up to 12 months)
- Progression Free Survival (PFS)(Up to 12 months)
- Concentration of Alpha fetoprotein (AFP)(Up to 12 months)
- Quality of life (QoL)(Up to 12 months)
- Yttrium-90 distribution(Within 24 hours)
- Resection rate of liver target lesions(Within 6 months after administration)
- Radioactivity of Yttrium-90 for 9 participants, assessed by liquid scintillation counter(Within 168 hours)
研究者
研究点 (10)
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