Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
2021년 4월 7일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
10
단계
- 초기 1단계
연락처 및 위치
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연구 장소
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Hubei
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Wuhan, Hubei, 중국, 430061
- Hubei Provincial Hospital of Traditional Chinese Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Survival
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-Free Survival
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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연구 기록 날짜
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연구 주요 날짜
연구 시작 (실제)
2019년 4월 7일
기본 완료 (실제)
2020년 7월 24일
연구 완료 (실제)
2021년 3월 30일
연구 등록 날짜
최초 제출
2019년 2월 21일
QC 기준을 충족하는 최초 제출
2019년 2월 21일
처음 게시됨 (실제)
2019년 2월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 4월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 4월 7일
마지막으로 확인됨
2021년 4월 1일
추가 정보
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