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Jiu-wei-zhen-xiao Granule for Advanced Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT03851471
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Zhong Wang, China Academy of Chinese Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Jiu-wei-zhen-xiao Granule Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 13, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: 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.
Drug: 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.




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: Up to 12 weeks ]
    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 :
  1. Progression-Free Survival [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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 .

  2. European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) (Chinese version, Version 3.0) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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.

  3. The level of the liver function [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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).

  4. The level of AFP [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    AFP is the abbreviation of alpha fetoprotein, which could be the progress of the primary hepatocellular carcinoma

  5. The level of coagulation function [ Time Frame: Baseline, 12 weeks ]
    The biochemical indicators of the coagulation function include prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB).

  6. The size of solid tumors [ Time Frame: Baseline, 12 weeks ]
    The size of solid tumors is measured by a professional film reader using MRI/CT.

  7. "Du-tan-yu-jie Zheng" symptoms score in Chinese medicine [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    "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

  8. 10cm-VAS of the pain [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
    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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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age:18~75 years;
  2. 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:

  1. Patients with unstable vital signs;
  2. 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;
  3. Known history of allergy to the ingredients of this product;
  4. 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;
  5. Receipt of any other investigational agents ≤ 1 month of the first dose of study treatment;
  6. Patients who cannot take oral medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851471


Contacts
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Contact: Zhong Wang, M.D., Ph.D. 86-10-64093207 zhonw@sina.com
Contact: Jun Liu, M.D., Ph.D. franlj1104@aliyun.com

Locations
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China, Hubei
Hubei Provincial Hospital of Traditional Chinese Medicine Recruiting
Wuhan, Hubei, China, 430061
Contact: Bao-ping Luo       2392186906@qq.com   
Principal Investigator: Bao-ping Luo         
Sponsors and Collaborators
Zhong Wang

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Responsible Party: Zhong Wang, Vice-director, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03851471     History of Changes
Other Study ID Numbers: JIUWEI-Gan 1-Ver1.0
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases