Assessment of Response to Locoregional Therapy Using Liquid Biopsy in Patients With Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment
研究概览
简要总结
Circulating tumor DNA (ctDNA) carrying tumor-specific sequence alterations has been found in the cell-free fraction of blood. Hepatocellular carcinoma (HCC) specimens are difficult to obtain, and noninvasive methods are required to assess cancer progression and characterize underlying genomic features. Use of 'liquid biopsy' by assessing circulating cell free DNA enables the clinician to offer targeted immunotherapy or signaling pathway inhibitors. It also offers a model to prove response to locoregional or immunotherapy therapy and predict tumor recurrence non-invasively.
详细描述
Novelty:
Mutation analysis may not only help identify cancer drivers, but they can also provide useful data to predict response to other treatment modalities such as immunotherapies, particularly immune checkpoint blockade. There is published data on liquid biopsy in India from oncology in the field of pulmonary and renal cancers, but these studies have not been done in cirrhosis or in HCC patients.
Objectives In this project we hope to develop a biomarker panel which helps us prognosticate patients and tailor targeted therapy as per their genetic mutation landscape. The treatment options for advanced HCC are limited, and tissue biopsy is not routinely performed.
Methods In this pilot project, we will analyze 30 patients with unresectable hepatocellular carcinoma, ineligible for liver transplantation, who will undergo locoregional therapy in the form of transarterial chemoembolization (TACE) or radioembolization (TARE) for tissue diagnosis of tumor tissue DNA and circulating tumor DNA. We will design personalized assays targeting somatic rearrangements of each tumor to quantify serum ctDNA. Exome sequencing will be performed using cell-free DNA and paired primary tumor tissue DNA in order to create a non-invasive liquid biopsy for diagnosis and prognostication of HCC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hepatocellular carcinoma BCLC stages B and C of all aetiology, unresectable
- •Age 18-70 years of either sex
排除标准
- •Contemplating Hepatic resection or OLT
- •Refractory ascites
- •Severe Coagulation disorders prior to the procedure (PTI <70% and Platelet count < 80,000/mm3)
- •Hepato-Renal syndrome
- •Chronic Kidney Disease
- •Acute decompensation like Hepatic encephalopathy and variceal bleeding
- •Any known malignancy other than HCC
- •Life expectancy < 6 months
结局指标
主要结局
Serial Quantification of ctDNA in plasma samples by means of real-time PCR post treatment
时间窗: 90 days
Comparison of exome sequencing of primary tumor tissue and cell-free DNA from plasma samples
时间窗: 0, 90 days
次要结局
- Time to first recurrence (local or distant) diagnosed on follow up dynamic imaging.(90 days)
- Mortality(90 days)
研究者
Madhumita Premkumar
Assistant Professor, Department of Hepatology
Post Graduate Institute of Medical Education and Research, Chandigarh