Outcomes of Stereotactic Body Radiotherapy in the Management of Portal Vein tumour Thrombosis in Hepatocellular Carcinoma: An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- 1. To evaluate the radiological response of portal vein tumor thrombus (PVTT) following SBRT using mRECIST criteria, assessing changes in tumor viability based on arterial-phase enhancement and measuring PVTT size pre- and post-SBRT at 2, 4, and 6 months.
研究概览
简要总结
Management Of Hepatocellular carcinoma with portal vein tumour thrombosis is a challenge in the current era with multiple modalities of treatment available from Radiofrequency ablation , Immunotherapy and Radiotherapy. In this study we will be recruiting patients of HCC with portal vein tumour thrombosis and using Stereotactic Body Radiotherapy technique will be delivering high dose of radiation to the tumour thrombus and then will be serially followed up with imaging to assess response .
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of Hepatocellular Carcinoma (HCC) with radiologically or histologically confirmed portal vein tumor thrombosis (PVTT).
- •ECOG Performance Status of 0–2
- •BCLC stage C
- •Child-Pugh Class A or B liver function status
- •Adequate remaining liver volume, defined as at least 700 cc of uninvolved liver tissue.
排除标准
- •Presence of metastatic disease outside the liver.
- •Previous radiotherapy to the liver.
- •Child-Pugh Class C liver function status with Child pugh score of 10 to 15.
结局指标
主要结局
1. To evaluate the radiological response of portal vein tumor thrombus (PVTT) following SBRT using mRECIST criteria, assessing changes in tumor viability based on arterial-phase enhancement and measuring PVTT size pre- and post-SBRT at 2, 4, and 6 months.
时间窗: 1. To evaluate the radiological response of portal vein tumor thrombus (PVTT) following SBRT using mRECIST criteria, assessing changes in tumor viability based on arterial-phase enhancement and measuring PVTT size pre- and post-SBRT at 2, 4, and 6 months. | 2. We will also measure the biochemical level of AFP and PIVKAA II before SBRT and after SBRT at 2 months ,4 months and 6 months.
2. We will also measure the biochemical level of AFP and PIVKAA II before SBRT and after SBRT at 2 months ,4 months and 6 months.
时间窗: 1. To evaluate the radiological response of portal vein tumor thrombus (PVTT) following SBRT using mRECIST criteria, assessing changes in tumor viability based on arterial-phase enhancement and measuring PVTT size pre- and post-SBRT at 2, 4, and 6 months. | 2. We will also measure the biochemical level of AFP and PIVKAA II before SBRT and after SBRT at 2 months ,4 months and 6 months.
次要结局
- 1. To assess acute toxicity profile of SBRT in patients with PVTT, using RTOG scoring criteria.(at third fraction)
研究者
Dr Sankhya Chatterjee
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh