Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy

Study Overview
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Brief Summary
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Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients were presented with advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC or tumors causing portal vein thrombosis. With the development of novel radiotherapy (RT) technique, RT can be safely given to patients with larger tumor or portal vein thrombosis. However, RT could achieve a tumor response rate of approximately 50 %. Currently, there was a paucity of studies regarding a quantitative biomarker to predict tumor response or forecast the outcome in advance. To optimize the therapeutic index, there is a need to seek effective biomarkers for personal medicine because pretreatment AFP is not always useful as a surrogate marker in some of the patients. The present study is to investigate whether circulating tumor cell genome in peripheral blood can be used to predict RT response in HCC. We will use the blood sample from patients with locally advanced HCC receiving RT. By using next generation sequencing, We are going to explore the quantity and quality changes of DNAs and RNAs in the patient's serum or plasma. By this way, genomic expression in peripheral blood may play a key role in determining the optimal therapeutic strategies for HCC patients by predicting tumor response to RT.

Detailed Description
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Patients with hepatocellular carcinoma requiring radiotherapy

Official Title
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Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy

Conditions
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Circulating Neoplastic Cells, Adverse Effect of Radiation Therapy, Fatal Outcome

Intervention / Treatment
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* Genetic: hepatoma requiring radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with unresectable hepatoma with transarterial chemoembolization (TACE) failure or who are not suitable for TACE. A maximal tumor diameter > 3.0 cm Age > 20, and < 80 years ECOG 0 or 1 Life expectancy of at least 12 weeks Child-Pugh A Cancer of the Liver Italian Program (CLIP) score ≦ 3 Pretreatment liver function test and renal function test:Total bilirubin < 1.5 times the upper limit of normal (ULN), GOP/GPT ≦ 5 X of upper limit of normal range, Alkaline phosphatase ≦ 4X of ULN, Prothrombin time / partial prothrombin time < 1.5 X of ULN, Serum Creatinine ≦ 1.0 x ULN Pretreatment blood count:Hemoglobulin ≧ 9 g/dl, Absolute neutrophil count ≧ 1500/mm3,Platelet count ≧ 100,000/mm3 Subjects with at least one uni-dimensional or bi-dimensional measurable lesion and lesion must be measured by CT scan Exclusion Criteria: Child-Pugh C CLIP score ≧ 4 Patients with evidence of extrahepatic or metastatic disease Patients with evidence of massive ascites Patients receiving previous irradiation to liver

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatoma, Circulating tumor genome<br>Hepatoma requiring radiotherapy | Genetic: hepatoma requiring radiotherapy<br>* hepatoma requiring radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | The correlation between response rate and circulating tumor cell genome | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival, relapse-free survival |  | two year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, genomic expression, radiotherapy