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.
調査の概要
詳細な説明
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Taichung、台湾、404
- China Medical University Hospital
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Hepatoma, Circulating tumor genome
Hepatoma requiring radiotherapy
|
hepatoma requiring radiotherapy
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Response rate
時間枠:one month
|
The correlation between response rate and circulating tumor cell genome
|
one month
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Overall survival, relapse-free survival
時間枠:two year
|
two year
|
協力者と研究者
捜査官
- スタディディレクター:Shang-Wen Chen, MD、China Medical University Hosptal
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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