NCT05957640招募中1 期
Yttrium-90 Carbon Microspheres in Patients With Unresectable Hepatocellular Carcinoma: A Multicentre, Prospective, Open-label, Single-arm Trial
Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月5日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Objective response rates (ORR)
研究概览
简要总结
To evaluate the efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable hepatocellular carcinoma
详细描述
The efficacy and safety of yttrium-90 carbon microspheres in patients with unresectable hepatocellular carcinoma remain unknown. This multicentre, prospective, open-label, single-arm trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres in patients with hepatocellular carcinoma. The primary endpoints are safety and local objective response rate of liver target lesions. While the secondary endpoints include the time to progression, progression-free survival rates, disease control rates, duration of response, quality of life and the distribution characteristics of yttrium-90 carbon microspheres.
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
- •Eastern Cooperative Oncology Group performance status ≤ 1;
- •Expected survival time ≥ 3 months;
- •Confirmed hepatocellular carcinoma based on EASL or AASLD guidelines;
- •Without extrahepatic metastases, inoperable or refuse surgical resection;
- •At least one well defined tumor (mRECIST 1.1);
- •Tumor burden ≤ 50% of the total liver volume;
- •Child-Pugh score ≤ 7;
- •Adequate organ function: # Blood routine [no blood transfusion or colony-stimulating factor (G-CSF) treatment within 14 days]: absolute neutrophil count ≥ 1.5 × 109/L; platelet ≥ 75 × 109/L; hemoglobin ≥ 90 g/ L; # Liver function: total bilirubin ≤ 2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase ≤
- •0 ULN; alkaline phosphatase ≤ 2.5 ULN; Albumin > 30 g/L; # Renal function: Cr ≤ 1.5 ULN; creatinine clearance ≥ 50 mL/min (calculated according to Cockcroft-Gault formula); # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN; # Cardiovascular function: left ventricular ejection fraction ≥ 50%;
- •According to CTCAE 5.0 standard, all adverse events of previous systematic anti-cancer treatment have recovered to baseline or ≤ 1 grade, [except for the following: neuropathy induced by previous anticancer treatment is stable (≤ 2 grade) and hair loss];
- •Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial. Men are forbidden to donate sperm. The pregnancy test results of female patients of childbearing age during the screening period and within 24 hours before administration must be negative.
排除标准
- •With previous history of hepatic encephalopathy;
- •Severe pulmonary insufficiency (forced expiratory volume at one second / forced vital capacity < 50% or forced expiratory volume at one second /predicting value < 50% or maximum volume per minute < 50 L/min);Obvious chronic obstructive pulmonary disease or interstitial pneumonia;
- •Percentage of hepatopulmonary shunt > 10%, or the single lung radiation absorbed dose > 30 Gy;
- •With hepatic artery malformation and unable to intubate hepatic artery;
- •Tumor thrombus in main portal vein;
- •Have received radiotherapy or transcatheter arterial chemoembolization (patients who have received transcatheter arterial non-iodized oil chemoembolization are judged by researchers);
- •The last anti-tumor treatment (surgery, chemotherapy, immunotherapy, targeted therapy) was less than 4 weeks before the drug administration;
- •Clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis;
- •Participated in other trial within 1 month before yttrium-90 administration;
- •Pregnant and lactating women;
- •Serious infections in active stage or need systematic treatment;
- •With positive results of HIV antibody test;
- •The researchers judge that there is unresolved toxicity from previous treatment and will continue to exist, which may endanger the safety of patients;
- •The researcher judged clinical or laboratory examination abnormality or other reasons;
- •Extrahepatic disease or combined with other malignant tumors;
- •Hepatic artery angiography and 99mTc MAA hepatic artery perfusion imaging demonstrate gastrointestinal shunts, which may not be remedied through vascular intervention techniques.
结局指标
主要结局
Objective response rates (ORR)
时间窗: 3 months after yttrium-90 injection
Liver target lesions, evaluated by the investigator and independent image review committee respectively (CTCAE 5.0)
Adverse events
时间窗: Up to 24 months
Rates of adverse events
次要结局
- Hepatic time to progression (hTTP)(Up to 24 months)
- Alpha fetoprotein (AFP)(Up to 24 months)
- Progression Free Survival Rate (PFS)(3 months after yttrium-90 injection)
- Duration of response (DOR)(Up to 24 months)
- Resection rate of liver target lesions(Within 6 months)
- Yttrium-90 distribution(Within 24 hours)
- Time to progression (TTP)(Up to 24 months)
- Quality of life (QoL)(Up to 24 months)
- Disease control rate (DCR)(Up to 24 months)
研究者
Gao-jun Teng
Dean
Zhongda Hospital
研究点 (1)
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