- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
-
-
-
Taichung, Taiwan, 404
- China Medical University Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Hepatoma, Circulating tumor genome
Hepatoma requiring radiotherapy
|
hepatoma requiring radiotherapy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Response rate
Tidsram: one month
|
The correlation between response rate and circulating tumor cell genome
|
one month
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Overall survival, relapse-free survival
Tidsram: two year
|
two year
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Shang-Wen Chen, MD, China Medical University Hosptal
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Patologiska processer
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Adenocarcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i matsmältningssystemet
- Leversjukdomar
- Neoplasmer i levern
- Neoplastiska processer
- Neoplasma Metastas
- Carcinom
- Karcinom, hepatocellulärt
- Neoplastiska celler, cirkulerande
Andra studie-ID-nummer
- CMUH102-REC2-112
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