- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066974
Circulating Tumor Cell Genome in Peripheral Blood From Hepatocellular Carcinoma Patients Under Radiotherapy
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 404
- China Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Hepatoma, Circulating tumor genome
Hepatoma requiring radiotherapy
|
hepatoma requiring radiotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: one month
|
The correlation between response rate and circulating tumor cell genome
|
one month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival, relapse-free survival
Time Frame: two year
|
two year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Shang-Wen Chen, MD, China Medical University Hosptal
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Neoplastic Processes
- Neoplasm Metastasis
- Carcinoma
- Carcinoma, Hepatocellular
- Neoplastic Cells, Circulating
Other Study ID Numbers
- CMUH102-REC2-112
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adverse Effect of Radiation Therapy
-
Larkin Community HospitalCompletedAdverse Effect of Radiation Therapy
-
Kantonsspital MünsterlingenActive, not recruitingAdverse Effect of Radiation TherapySwitzerland
-
Indiana UniversityNational Institute of General Medical Sciences (NIGMS)CompletedAdverse Effect of Drug Therapy Metabolism Medications (Diagnosis)United States
-
Chulabhorn Cancer CenterCompletedBreast Neoplasms | Radiodermatitis | Adverse Effect of Radiation TherapyThailand
-
Assiut UniversityCompletedAdverse Effect of Drug Therapy LevodopaEgypt
-
AdventHealthCompletedRadiation Exposure | Fluoroscopy; Adverse EffectUnited States
-
National Taiwan University HospitalUnknown
-
Postgraduate Institute of Medical Education and...CompletedBreast Cancer | Adverse Effect of Radiation TherapyIndia
-
RadiotherapieCompletedMelanoma | Effects of Immunotherapy | Adverse Effect of Radiation TherapyBelgium
-
Chulabhorn HospitalCompletedHead and Neck Cancer | Adverse Effect of Radiation Therapy | Radiation- Induced MucositisThailand
Clinical Trials on hepatoma requiring radiotherapy
-
AdministrateurCICCompleted
-
University Medicine GreifswaldRecruitingRetinopathy of PrematurityGermany, Greece, Austria, Bulgaria, Estonia, France, Kosovo, Poland, Spain, Switzerland, Turkey, Ukraine
-
University Hospital, GrenobleTerminatedPatient Requiring Mechanical VentilationFrance
-
Hennepin County Medical Center, MinneapolisRecruitingTraumatic Brain InjuryUnited States
-
National University Hospital, SingaporeCompleted
-
University Hospital MuensterRecruitingTracheobronchitis | Herpes Simplex InfectionGermany
-
Hospital Moinhos de VentoActive, not recruitingCOVID-19 | Quality of Life | Disability Physical | Disabilities MentalBrazil
-
Poznan University of Medical SciencesUniversity at Buffalo; The Greater Poland Cancer CentreActive, not recruitingPopulation Modeling of Anti-infective DrugsPoland
-
Centre Chirurgical Marie LannelongueRecruiting