NCT05866172招募中3 期
A Randomized Controlled Study of Hepatic Arterial Infusion Chemotherapy of FOLFOX With or Without Zoledronic Acid for the Prevention of Bone Metastases in Advanced Hepatocellular Carcinoma Staged at BCLC C
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 264 人开始时间: 2023年5月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Zoledronic acid was initially used for bone metastases in various malignancies. However, it is unknown whether hepatic arterial infusion chemotherapy combined with zoledronic acid can improve overall survival of unresectable hepatocellular carcinoma.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- •Unresectable HCC. For BCLC C HCC, sorafenib/lenvatinib or PD-1/L1 antibody was allowed.
- •Eastern Cooperative Oncology Group performance status of 0 to 2
- •with no previous treatment
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- •The following laboratory parameters:
- •Platelet count ≥ 75,000/μL
- •Hemoglobin ≥ 8.5 g/dL
- •Total bilirubin ≤ 30mmol/L
- •Serum albumin ≥ 30 g/L
- •ASL and AST ≤ 5 x upper limit of normal
- •Serum creatinine ≤ 1.5 x upper limit of normal
- •INR ≤ 1.5 or PT/APTT within normal limits
- •Absolute neutrophil count (ANC) >1,500/mm3
- •Ability to understand the protocol and to agree to and sign a written informed consent document
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of bleeding diathesis.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known central nervous system tumors including metastatic brain disease
研究组 & 干预措施
HAIC with zoledronic Acid
Experimental
干预措施: HAIC (Procedure)
HAIC with zoledronic Acid
Experimental
干预措施: Zoledronic acid (Drug)
HAIC without zoledronic Acid
Active Comparator
干预措施: HAIC (Procedure)
结局指标
主要结局
overall survival
时间窗: 12 months
OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
次要结局
- Progression Free Survival (PFS)(12 months)
- Objective Response Rate (ORR)(12 months)
- Adverse Events(30 days)
研究者
Shi Ming
Professor
Sun Yat-sen University
研究点 (1)
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