Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Recurrence in Hepatocellular Carcinoma Patients
A Randomized Controlled Study on the Effect of Intraoperative Controlled Release 5-Fluorouracil Therapy on Anti-tumor Recurrence in Hepatocellular Carcinoma Patients With High Risk of Microvascular Invasion Presence
調査の概要
詳細な説明
Surgical resection is the major curative treatment for patients with hepatocellular carcinoma (HCC). However, the postoperative 5-year recurrence rate after surgical resection was significantly high, which has been reported to 40%-70%.
Recurrence after surgery is the main factor affecting the efficacy of management of hepatocellular carcinoma, however, there are few methods for the prevention of recurrence and no standard treatment for recurrent HCC following curative-intent initial surgery has been established so far. The effective prevention of recurrence is the key to improve the management of HCC.
Previous studies showed the prevalence of microvascular invasion (MVI) in one of the critical and negative prognostic factors for HCC patients after partial hepatectomy or liver transplantation. For the early stage HCC patients, preoperative prediction of MVI is helpful to identify the appropriate object of anti-recurrence treatment before or after operation.
Our another previous study established a nomogram for MVI prediction of early HCC patients, which can preoperative efficiently predict the occurrence of MVI within Milan criteria, has been published online in JAMA surgery. On the other hand, there are only few studies reported the use of controlled release 5-Fluorouracil in the treatment of digestive tract tumors.
The action time of the controlled release 5-Fluorouracil particles is more than 15 days, the diffusion radius is 4-6cm. In theory, during the operation, the drug can be given to any location that may have tumor residues, timely and conveniently, and has a long time to maintain a high drug concentration, which is conducive to kill small metastatic foci caused by MVI. However, to our best knowledge, there is no evidence of high levels of evidence-based medical evidence to confirm the value of controlled release 5-Fluorouracil in the prevention of HCC recurrence.
In view of this, we aim to implement a randomized controlled study to confirmed the role of intraoperative controlled release 5-Fluorouracil therapy in the prevention of recurrence after surgery for HCC patients with high risk of preoperative prediction of microvascular invasion.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Shanghai
-
Shanghai、Shanghai、中国、200438
- Eastern hepatobilliary surgery 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
説明
Inclusion Criteria:
- Male or female patients > 18 years and <=70 years of age
- Patients preoperatively diagnosed of hepatocellular carcinoma according to the criteria of American Association for the Study of Liver Diseases(AASLD)
- Within Milan criteria
- Nomogram score for MVI prediction >200
- Preoperative ECOG criteria score of 0-1
- Child-Pugh class A liver function
- No Anticancer treatment before surgery
Exclusion Criteria:
- Major portal/hepatic vein invasion
- Extrahepatic metastasis
- Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer
- Lost to follow-up
- Patients participating in other clinical trials
- Patients refused to join our trial
- Pregnant and breast-feeding women
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Hepatectomy
Surgical removal of all lesions
|
すべての病変を外科的に除去する
|
実験的:Hepatectomy plus 5-Fluorouracil
Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy
|
すべての病変を外科的に除去する
Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy
|
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 |
時間枠 |
---|---|
腫瘍再発までの時間
時間枠:5年
|
5年
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
全生存
時間枠:5年
|
5年
|
協力者と研究者
捜査官
- スタディチェア:Shen Feng, MD、Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。