Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients
2017年2月21日 更新者：Xiang Hua、Hunan Provincial People's Hospital
A Prospective Multicenter Randomized Controlled Open-label Trial of Transcatheter Arterial Chemoembolization (TACE) in Combination With Arsenic Trioxide Versus TACE in the Treatment of Middle-advanced Primary Hepatocellular Carcinoma (HCC) Patients
A multicentre, randomized, open-label, parallel-group, active controlled study.
調査の概要
詳細な説明
Primary hepatocellular carcinoma (HCC) is one of the most common types of cancer and accounts for significant morbidity and mortality worldwide. Notably, more than half of the new HCC cases and deaths develop in China. Transarterial chemoembolization (TACE) has been proposed as the first-line therapeutic strategy for the treatment of patients with unresectable HCC. However, TACE has several limitations itself which might be potentially associated with tumor metastasis and relapse.
Recent studies have demonstrated that arsenic trioxide (As2O3) can act as the first-line therapeutic option in the treatment of acute promyelocytic leukemia. Thereafter, several small studies in China showed promising clinical benefits when As2O3 is administrated among the HCC patients. With these preliminary results, the investigators are planning to carry out a multicenter randomized controlled trial through which to explore the potential efficacy and safety of adjuvant As2O3 treatment for HCC patients.
研究の種類
介入
入学 (予想される)
190
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Guizhou
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Guiyang、Guizhou、中国
- Guizhou Cancer Hospital
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Guiyang、Guizhou、中国
- Guizhou Province Tumor Hospital
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Hunan
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Changsha、Hunan、中国
- Hunan Cancer Hospital
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Changsha、Hunan、中国
- Xiangya Hospital Central South University
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Changsha、Hunan、中国、410001
- Hunan Provincial People's Hospital
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Hengyang、Hunan、中国
- The First Affiliated Hospital of University of South China
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Jiangsu
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Nanjing、Jiangsu、中国
- Jiangsu Province Hospital
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Xinjiang
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Urumqi、Xinjiang、中国
- Xinjiang Medical University Cancer Hospital
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Yunnan
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Kunming、Yunnan、中国
- The Tumor Hospital of Yunnan Province
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
- Subject is 18-80 years old.
- Subject has no portal stem vein tumor thrombus.
- Subject has primary middle-advanced liver cancer of Barcelona Clinic Liver Cancer stages B/C inappropriate for surgical resection or other locoregional therapy and still presents with tumor lesions in the liver.
- Subject has evaluable tumor lesion(s) (using Magnetic Resonance Imaging /Computed Tomography) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1: single lesion size ≥5cm or at least one lesion of >3cm in size when 2-3 lesions exist or there are 4 or more lesions.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤1, Fibrosis index based on 4 factors (FIB-4)≤6 and an expected survival time of 12 weeks or more.
- Haematology: white blood cell count ≥3.0×10^9/L; hemoglobin≥10 g/dL; blood platelet count≥80×10^9/L
- Blood biochemistry: serum albumin ≥2.8 g/dL, total bilirubin ≤2 mg/dL or ≤34.2 umol/L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 times of upper limit of normal (ULN); amylase and lipase ≤ 1.5 times of ULN; serum creatinine ≤2.0 mg/dL or < 1.5 times of ULN; estimated creatinine clearance ≥60 mL/min.
- International normalized ratio (INR) is ≤ 2.3 or prothrombin time (PT) is ≤3 seconds than upper limit of normal control.
- Echocardiogram indicated a left ventricular ejection fraction (LVEF) of >50%.
- Subject has a liver function Child-Pugh class A or B.
- Subject is not pregnant or lactating.
- Female subjects must be infertile or agree to take effective contraceptives; male subjects and their partners of reproductive potential must also agree to use appropriate contraceptives.
- Subject had no second tumor in the last 5 years, excluding skin basal cell carcinoma or skin squamous carcinoma or any other carcinoma in situ.
- Subject had no history of systemic chemotherapy.
- Subject has no any other concomitant anticancer therapies, such as local radiotherapy, systemic chemotherapy and molecular targeted therapy.
- Subject and (or) guardian is able to understand this study and willing to provide written, informed consent to participate in this clinical study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 plus Arsenic Trioxide
Patients in this group are to receive a single dose of TACE treatment on day 1, followed by arsenic trioxide at 10 mg/day for 14 days (day 8-21).
TACE treatment is repeated every 9 weeks while arsenic trioxide every 3 weeks for treatment duration of 27 weeks.
At least 3 cycles of arsenic trioxide are administrated.
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After the puncture of femoral artery via Seldinger method, a catheter was inserted and digital celiac axis or hepatic arteriography performed.
Then a microcatheter was used to infuse chemotherapeutic agent (30 to 60 mg of pirarubicin) mixed with 5 to 20 mL of Lipiodol Ultra-Fluid.
Embosphere microspheres (size of 100 to 300 um) were inserted for embolization.
Arsenic trioxide 10 mg is put into 500 ml saline solution and then administrated by continuous intravenous drip for 5 hours during a treatment day.
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アクティブコンパレータ：TACE
Patients in this group are to receive a single dose of TACE treatment on day 1.
TACE treatment is repeated every 9 weeks for 27 weeks.
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After the puncture of femoral artery via Seldinger method, a catheter was inserted and digital celiac axis or hepatic arteriography performed.
Then a microcatheter was used to infuse chemotherapeutic agent (30 to 60 mg of pirarubicin) mixed with 5 to 20 mL of Lipiodol Ultra-Fluid.
Embosphere microspheres (size of 100 to 300 um) were inserted for embolization.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Progression free survival
時間枠：2-year
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Progression free survival (PFS) is defined as the time interval from the day of the random assignment to the first evidence of progression or death.
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2-year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Objective response rate
時間枠：2-year
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Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST and will be assessed by the investigators.
The tumor objective response rate (ORR) is calculated per treatment arm as the proportion of randomized patients having a confirmed best response of CR or PR.
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2-year
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Overall Survival
時間枠：2-year
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Overall survival will be measured from the date of randomization up to the date of death of any cause
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2-year
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Incidence of adverse events
時間枠：Up to 2 years through study completion
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Toxicities will be evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v 4.0.
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Up to 2 years through study completion
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Quality of life using EuroQol five dimensions five levels questionnaire
時間枠：Baseline and week 6, 12, 18, 24 and 30 using EuroQol five dimensions five levels questionnaire
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Baseline and week 6, 12, 18, 24 and 30 using EuroQol five dimensions five levels questionnaire
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Hua Xiang, Dr.、Hunan Provincial People's Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2016年11月1日
一次修了 (予想される)
2019年11月1日
研究の完了 (予想される)
2020年11月1日
試験登録日
最初に提出
2016年11月2日
QC基準を満たした最初の提出物
2016年11月4日
最初の投稿 (見積もり)
2016年11月6日
学習記録の更新
投稿された最後の更新 (実際)
2017年2月23日
QC基準を満たした最後の更新が送信されました
2017年2月21日
最終確認日
2017年2月1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。