NCT06909708招募中不适用
SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)
Zhongda Hospital1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年4月3日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time to progression (TTP)
研究概览
简要总结
To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma
详细描述
The efficacy and safety of yttrium-90 carbon microspheres versus in patients with unresectable hepatocellular carcinoma (HCC) remain unknown. This multicenter, prospective, open-label, phase 3 trial is designed to evaluate the safety and efficacy of yttrium-90 carbon microspheres versus conventional TACE in patients with hepatocellular carcinoma. The primary endpoint is time to progression for patients with HCC. While the secondary endpoints include the overall response rate, duration of response, local time to progression, tumor biomarkers variation, overall survival and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Eastern Cooperative Oncology Group performance status ≤ 1;
- •Expected survival time ≥ 3 months;
- •Confirmed hepatocellular carcinoma based on CNLC guidelines;
- •Without extrahepatic metastases, unresectable 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: absolute neutrophil count ≥ 1.5×10^9/L; platelet≥75×10^9/L; hemoglobin≥90 g/L; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin>30 g/L; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL/min; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN;
- •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.
排除标准
- •With previous history of hepatic encephalopathy;
- •Extrahepatic disease or combined with other malignant tumors;
- •Infiltrative hepatocellular carcinoma ;
- •With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;
- •With hepatic artery malformation and unable to undergo TACE or SIRT;
- •Allergy to contrast agents or anesthetics
- •With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal/gastric varices;
- •With 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);
- •The single lung radiation absorbed dose>30 Gy;
- •Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;
- •Serious infections in active stage or need systematic treatment;
- •Pregnant and lactating women;
- •With positive results of HIV antibody test;
- •HBV DNA or HCV RNA positive;
- •With active syphilis or tuberculosis;
- •99mTc-MAA imaging (patients exclusion meet all criteria):
- •Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy < PNLD <1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD <120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.
结局指标
主要结局
Time to progression (TTP)
时间窗: From enrollment to 54 weeks after the treatment
Evaluated by the independent image review committee (CTCAE 5.0)
次要结局
- Adverse events(From enrollment to 54 weeks after the treatment)
- Severe adverse events(From the enrollment to 54 weeks after the treatment.)
- localized time to progression(From the enrollment to 54 weeks after the treatment.)
- Objective response rates (ORR)(From enrollment to 54 weeks after the treatment.)
- Overall survival (OS)(From the enrollment to the death or lost to follow up.)
- Duration of response (DoR)(From the enrollment to 54 weeks after the treatment)
- Resection rate of liver target lesions(From enrollment to 54 weeks after the treatment.)
- Tumor markers(From the enrollment to 54 weeks after the treatment.)
研究者
Gao-jun Teng
Director of Interventional and Vascular Surgery Department
Zhongda Hospital
研究点 (1)
Loading locations...
相似试验
招募中
3 期
the Efficacy and Safety of Ondansetron Oral Soluble PelliclesNausea and VomitingNCT06282211The First Affiliated Hospital of Xinxiang Medical College184
尚未招募
4 期
Clinical Study of Huaier Granules in Patients With Advanced Breast Cancer Without Visceral MetastasisBreast Cancer Stage IVNCT05860907Fudan University384
Unknown
4 期
Comparison Three vs Twelve Months of Dual Anti-Platelet Therapy After Stent ImplantationDrug-Eluting StentsPercutaneous Coronary InterventionNCT03008083Shanghai MicroPort Medical (Group) Co., Ltd.2,446
招募中
不适用
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and IIIHeart FailureNCT05934487Endotronix, Inc.1,750
已完成
4 期
Clinical Study of Treating Type 2 Diabetic Nephropathy With Alfacalcidol and IrbesartanType 2 Diabetic NephropathyNCT03147677The Third Xiangya Hospital of Central South University60