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

Adverse Effect of Radiation Therapy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02066974
• Other study ID #: CMUH102-REC2-112
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 3, 2015
• Start date: January 2014
• Est. completion date: February 2016

Study information

• Verified date: February 2015
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Patients with hepatocellular carcinoma requiring radiotherapy

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 79 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adverse Effect of Radiation Therapy
• Carcinoma, Hepatocellular
• Circulating Neoplastic Cells
• Fatal Outcome
• Neoplastic Cells, Circulating

Intervention

Genetic:
• hepatoma requiring radiotherapy
hepatoma requiring radiotherapy

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	The correlation between response rate and circulating tumor cell genome	one month	No
Secondary	Overall survival, relapse-free survival		two year	No