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

China Medical University, China

Status

Unknown

Conditions

Circulating Neoplastic Cells

Fatal Outcome

Adverse Effect of Radiation Therapy

Treatments

Genetic: hepatoma requiring radiotherapy

Study type

Observational

Funder types

Other

Identifiers

NCT02066974

CMUH102-REC2-112

Details and patient eligibility

About

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.

Full description

Patients with hepatocellular carcinoma requiring radiotherapy

Enrollment

45 estimated patients

Sex

All

Ages

21 to 79 years old

Volunteers

No Healthy Volunteers

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