Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
2021年4月7日 更新者：Zhong Wang
An Open-label, Single-institution, Non-randomized, Single-arm, Pilot Study of Jiu-wei-zhen-xiao Granule for the Treatment in Patients With Advanced Hepatocellular Carcinoma
This is a piolt single-arm trial of Jiu-wei-zhen-xiao Granule, extracted from nine kinds of Chinese medicnie, for the treatment in patients with advanced, unresectable hepatocellular carcinoma(HCC).
The primary objective is to assess its therapeutic efficacy in patients with unresectable HCC.
The primary endpoint is overall survival (OS) after the use of 12-week drug.
Secondary endpoints include progression-free survival (PFS) after the use of 12-week drug, the improvement of the score of the European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30), the changes of the liver function, coagulation function, the size of solid tumors,"Du-tan-yu-jie Zheng" in Chinese medicine, pain Visual Analogue Scale and toxicity profile of Jiu-wei-zhen-xiao Granule.
調査の概要
研究の種類
介入
入学 (実際)
10
段階
- 初期フェーズ 1
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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Hubei
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Wuhan、Hubei、中国、430061
- Hubei Provincial Hospital of Traditional Chinese Medicine
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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～75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
Inclusion Criteria:
- Age:18~75 years;
- Patients must have diagnosis of advanced hepatocellular cancer (HCC) by one of the following:
(1) Histopathology; (2) Elevated serum alpha-fetoprotein (AFP) >400 ng/ml and findings on magnetic resonance imaging (MRI) or computed tomography (CT) scans characteristic of HCC; (3) Findings on triple phase MRI or CT scans characteristic of HCC in patients with cirrhosis and tumors at least 1 cm or greater, without a curative treatment option (transplant, resection, or ablation).
3.The clinical staging of HCC is B or C or D staging as the Barceln Clinical Liver Cancer Classification(BCLC);
4. Patients with hepatitis B virus infection;
5. Patients with "Du-tan-yu-jie Zheng" in Chinese medicine;
6. Karnofsky score ≥60;
7. Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients with unstable vital signs;
- Any uncontrolled, severe, intercurrent illness including but not limited to ongoing or active infection, heart, brain, lung and other systemic diseases or other kinds of tumors;
- Known history of allergy to the ingredients of this product;
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial through 120 days after the last dose of trial treatment;
- Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
- Patients who cannot take oral medication.
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：なし
- 介入モデル：単一グループの割り当て
- 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：Jiu-wei-zhen-xiao Granule
Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
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Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
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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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Overall Survival
時間枠：Up to 12 weeks
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Overall Survival (OS) is defined as the percentage of people in a group who are alive after the 12-week use of drug.
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Up to 12 weeks
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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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Progression-Free Survival
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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Progression-free survival (PFS) will be defined as the elapsed time from the first date of study treatment until documented disease progression (as per RECIST 1.1) or death from any cause, whichever is earlier.
For patients who remain alive without progression, follow-up time will be censored at the date of last disease assessment .
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Baseline, 4 weeks, 8 weeks, 12 weeks
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European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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EORTC QLQ-C30 is a 30-item questionnaire composed of multi-item scales and single items that reflect the multidimensionality of the QoL construct.
It includes five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), and a global health status/QoL scale.
The remaining single items assess additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea), as well as the perceived financial impact of the disease and treatment.
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Baseline, 4 weeks, 8 weeks, 12 weeks
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The level of the liver function
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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The biochemical indicators of the liver function include alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin(TBiL), direct bilirubin (DBiL), albumin (ALB), alkaline phosphatase (AKP), gamma-Glutamyltransferase (γ-GGT).
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Baseline, 4 weeks, 8 weeks, 12 weeks
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The level of AFP
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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AFP is the abbreviation of alpha fetoprotein, which could be the progress of the primary hepatocellular carcinoma
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Baseline, 4 weeks, 8 weeks, 12 weeks
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The level of coagulation function
時間枠：Baseline, 12 weeks
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The biochemical indicators of the coagulation function include prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
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Baseline, 12 weeks
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The size of solid tumors
時間枠：Baseline, 12 weeks
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The size of solid tumors is measured by a professional film reader using MRI/CT.
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Baseline, 12 weeks
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"Du-tan-yu-jie Zheng" symptoms score in Chinese medicine
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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"Du-tan-yu-jie Zheng" is a series of common symptoms in HCC，including distending pain in the hypochondrium,jaundice, a lump below the costal region,weak and lassitude, poor appetite,abdominal distension and fullness,dizziness and tinnitus, bitter or dry mouth,constipation, urinary yellow,upset and irritable,red or dark red tongue, stringy or rapid pulse
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Baseline, 4 weeks, 8 weeks, 12 weeks
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10cm-VAS of the pain
時間枠：Baseline, 4 weeks, 8 weeks, 12 weeks
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The 10cm Visual Analogue Scale (VAS) of the pain is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10) .
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Baseline, 4 weeks, 8 weeks, 12 weeks
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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。
スポンサー
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 (実際)
2019年4月7日
一次修了 (実際)
2020年7月24日
研究の完了 (実際)
2021年3月30日
試験登録日
最初に提出
2019年2月21日
QC基準を満たした最初の提出物
2019年2月21日
最初の投稿 (実際)
2019年2月22日
学習記録の更新
投稿された最後の更新 (実際)
2021年4月9日
QC基準を満たした最後の更新が送信されました
2021年4月7日
最終確認日
2021年4月1日
詳しくは
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