Adjuvant Therapies for Patients With HCC and MVI (A-TACE/S-HCC)
Adjuvant Transarterial Chemoembolization With or Without Sorafenib for Patients With Hepatocellular Carcinoma and Microvascular Invasion
Hepatocellular carcinoma (HCC) is a common malignancy, and its incidence is expected to increase in many countries in coming decades. Though prognosis for patients with HCC is generally poor, hepatic resection can be an effective curative treatment, and its indications have been expanding in recent years. Resection can be reasonably safe and effective even for patients with micro- or macrovascular invasion. However, the recurrence rate of HCC is as high as 74% for patients with intermediate and advanced HCC after resection. Microvascular invasion is one of the main risk factors which influence risk of HCC recurrence and patient prognosis after resection. Therefore, adjuvant therapy to prevent tumor recurrence after resection is so important to improve patient prognosis.
Nowadays, adjuvant transarterial chemoembolization (TACE) is reported to be effective in reducing early recurrence rate and mortality for patients with HCC with risk factors of recurrence. Sorafenib is a novel drug which is effective for advanced stage HCC. However, the efficacy of adjuvant sorafenib for postoperative HCC is unknown. Therefore, it is interesting to investigate the efficacy of adjuvant sorafenib, and compare its efficacy to TACE, TACE plus sorafenib, or best supportive care for patients with postoperative HCC and microvascular invasion.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ 3
連絡先と場所
研究場所
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Guangxi
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Nanning、Guangxi、中国、530021
- 募集
- Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
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コンタクト:
- Bang-De Xiang, MD,PhD
- 電話番号:86-771-5330855
- メール:xiangbangde@163.com
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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:
- Age 18-75 years
- Diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients
- Patients with microvascular invasion by histopathological examination of surgical samples
- Patients have Child-Pugh A or B liver function
- No previous neoadjuvant treatment
- No evidence of macrovascular invasion, metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- No malignancy other than HCC for 5 years prior to the initial HCC treatment
Exclusion Criteria:
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
- Known Central Nervous System tumors including metastatic brain disease
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients
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:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:TACE
Transarterial chemoembolization (TACE) is performed two to four weeks after hepatic resection.
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TACE is performed one month after resection.
他の名前:
This group will not receive adjuvant therapy.
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アクティブコンパレータ:sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.
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Sorafenib is submitted one month after resection.
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他の:TACE plus sorafenib
Patients will receive sorafenib at a dose of 400 mg twice daily after 2 weeks of hepatic resection.
At the same time, TACE is performed two to four weeks after hepatic resection.
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This group will not receive adjuvant therapy.
TACE plus sorafenib will be submitted one month after resection.
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介入なし:empty control
This group patients will receive best supportive care.
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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 |
---|---|
Overall survivals
時間枠:1 year
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1 year
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Hospital mortality
時間枠:30-day
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30-day
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Recurrence rates
時間枠:1 years
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1 years
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.
- Zhong JH, Li LQ. Postoperative adjuvant transarterial chemoembolization for participants with hepatocellular carcinoma: A meta-analysis. Hepatol Res. 2010 Oct;40(10):943-53. doi: 10.1111/j.1872-034X.2010.00710.x.
- Zhou L, Rui JA, Wang SB, Chen SG, Qu Q. Early recurrence in large hepatocellular carcinoma after curative hepatic resection: prognostic significance and risk factors. Hepatogastroenterology. 2014 Oct;61(135):2035-41.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- A-TACE/S-HCC
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。
TACEの臨床試験
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Beijing Tsinghua Chang Gung Hospitalわからない
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Beijing Tsinghua Chang Gung Hospitalわからない
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Ivy Life Sciences, Co., LtdTri-Service General Hospitalわからない