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

NCT ID: NCT02066974

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-02-29

Brief Summary

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

Patients with hepatocellular carcinoma requiring radiotherapy

Conditions

Circulating Neoplastic Cells; Adverse Effect of Radiation Therapy; Fatal Outcome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hepatoma, Circulating tumor genome

Hepatoma requiring radiotherapy

hepatoma requiring radiotherapy

Intervention Type: GENETIC

hepatoma requiring radiotherapy

Interventions

hepatoma requiring radiotherapy

hepatoma requiring radiotherapy

Intervention Type: GENETIC

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Shang-Wen Chen

Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shang-Wen Chen, MD

Role: STUDY_DIRECTOR

China Medical University Hosptal

Locations

China Medical University Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

CMUH102-REC2-112

Identifier Type: -

Identifier Source: org_study_id