NCT06766643招募中2 期
A Prospective, Randomized, Controlled Phase II Clinical Trial of Stereotactic Radiosurgery Versus Radiofrequency Ablation in Primary Liver Cancer in a Special Site of Surgical Evaluation for Non-operable
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2025年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
A phase II clinical trial of stereotactic radiosurgery versus radiofrequency ablation in the treatment of inoperable primary liver cancer in specific sites
详细描述
This study is a prospective, randomized, controlled Phase II clinical trial aimed at recruiting patients with primary liver cancer who are deemed inoperable after surgical evaluation, with tumor lesions located near major blood vessels, the diaphragm, the liver capsule, or the porta hepatis. The objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy and radiofrequency ablation as treatment options for such patients. It must be determined by the investigator whether stereotactic radiotherapy or radiofrequency ablation is the preferred treatment for these patients. Eligible patients will be randomly assigned in a 1:1 ratio to one of the following treatment groups: stereotactic radiotherapy or radiofrequency ablation. The study is expected to enroll 65 patients in each group.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior to implementing any trial-related procedures, written informed consent must be signed;
- •Age ≥ 18 years and ≤ 75 years;
- •Child-Pugh score ≤ 7;KPS score ≥ 70;
- •The patient must be clearly diagnosed with hepatocellular carcinoma, usually confirmed through imaging (CT, MRI) or histological examination (biopsy);
- •The tumor is located near major blood vessels/diaphragm/liver capsule/liver hilum;
- •Surgically assessed as inoperable hepatocellular carcinoma or recurrence of primary hepatocellular carcinoma within 2 years after radical treatment;
- •According to the criteria for evaluating the efficacy of solid tumors, there should be at least one measurable lesion by imaging, with the lesion size not exceeding 5 cm; total number of lesions ≤ 3;
- •No previous anti-tumor treatment;
- •Normal liver (liver volume minus tumor volume) is sufficient;
- •Normal major organ functions, including blood routine tests [absolute neutrophil count (ANC) ≥ 1.5 × 10^9, platelets ≥ 70 × 10^9, hemoglobin ≥ 80 g/L], liver function tests [bilirubin < 3.0 mg/dL, international normalized ratio (INR) < 1.7, albumin ≥ 2.8 g/dL, aspartate transaminase (AST)/alanine transaminase (ALT) < 6], serum creatinine < 1.5 times the upper limit of normal, or creatinine clearance ≥ 60 mL/min;
- •Stable respiration for more than 10 minutes;
- •Expected survival time > 2 years.
排除标准
- •Possible surgical intervention;
- •Presence of other serious comorbidities, such as uncontrolled cardiovascular diseases, pulmonary diseases, or dysfunction of other organs, where the overall health status is poor and may result in treatment intolerance;
- •Severe liver dysfunction exceeding the specific criteria defined in the trial;
- •Other malignancies diagnosed within 5 years prior to the first treatment or at the time of diagnosis of hepatocellular carcinoma;
- •Significant clinically meaningful bleeding symptoms or a clear bleeding tendency within 3 months prior to enrollment;
- •Currently participating in an interventional clinical trial treatment, or having received other investigational drugs or used investigational devices within 4 weeks before the first treatment;
- •Previous treatment with anti-target tumor therapies;
- •History of upper abdominal radiotherapy;
- •Uncontrolled active comorbidities;
- •Not meeting the expected survival prognosis or unable to provide informed consent.
研究组 & 干预措施
Radiofrequency ablation therapy group
Experimental
干预措施: Radiofrequency ablation therapy (Procedure)
Stereotactic body radiation therapy group
Experimental
干预措施: Stereotactic Body Radiation Therapy (SBRT) (Procedure)
结局指标
主要结局
PFS
时间窗: Until the end of the study, about 2 years
次要结局
- Overall survival rate(Until the end of the study, about 2 years)
- Local control rate(Until the end of the study, about 2 years)
- Intrahepatic control rate(Until the end of the study, about 2 years)
- Extrahepatic control rate(Until the end of the study, about 2 years)
研究者
研究点 (1)
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