Back to resultsJiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Jiu-wei-zhen-xiao Granule
Sponsored by
About this trial
This is an interventional treatment trial for Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Hubei Provincial Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jiu-wei-zhen-xiao Granule
Arm Description
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.
Outcomes
Primary Outcome Measures
Overall Survival
Overall Survival (OS) is defined as the percentage of people in a group who are alive after the 12-week use of drug.
Secondary Outcome Measures
Progression-Free Survival
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 .
European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)
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.
The level of the liver function
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).
The level of AFP
AFP is the abbreviation of alpha fetoprotein, which could be the progress of the primary hepatocellular carcinoma
The level of coagulation function
The biochemical indicators of the coagulation function include prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
The size of solid tumors
The size of solid tumors is measured by a professional film reader using MRI/CT.
"Du-tan-yu-jie Zheng" symptoms score in Chinese medicine
"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
10cm-VAS of the pain
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) .
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03851471
Brief Title
Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 7, 2019 (Actual)
Primary Completion Date
July 24, 2020 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhong Wang
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jiu-wei-zhen-xiao Granule
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Jiu-wei-zhen-xiao Granule
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS) is defined as the percentage of people in a group who are alive after the 12-week use of drug.
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Progression-Free Survival
Description
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 .
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0)
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
The level of the liver function
Description
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).
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
The level of AFP
Description
AFP is the abbreviation of alpha fetoprotein, which could be the progress of the primary hepatocellular carcinoma
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
The level of coagulation function
Description
The biochemical indicators of the coagulation function include prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).
Time Frame
Baseline, 12 weeks
Title
The size of solid tumors
Description
The size of solid tumors is measured by a professional film reader using MRI/CT.
Time Frame
Baseline, 12 weeks
Title
"Du-tan-yu-jie Zheng" symptoms score in Chinese medicine
Description
"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
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
Title
10cm-VAS of the pain
Description
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) .
Time Frame
Baseline, 4 weeks, 8 weeks, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hubei Provincial Hospital of Traditional Chinese Medicine
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430061
Country
China
12. IPD Sharing Statement
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Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma
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