Clinical trial NCT02066974: Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy
Official title: Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Circulating Neoplastic Cells
Adverse Effect of Radiation Therapy
Fatal Outcome
Keywords: hepatocellular carcinoma
genomic expression
radiotherapy
Lead sponsor: China Medical University, China
Sponsor class: OTHER
First posted: 2014-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with advanced hepatoma requiring radiotherapy

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

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

Primary outcomes:
measure: Response rate
timeFrame: one month
Secondary outcomes:
measure: Overall survival, relapse-free survival
timeFrame: two year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hosptal
name: Shang-Wen Chen, MD
role: STUDY_DIRECTOR
References: