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The Safety and Efficacy Evaluation of XSLJZ in Advanced Hepatocellular Carcinoma Patients With Multiple Protein Kinase Inhibitor Therapy: A Randomized, Double-Blind, Controlled Trial

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ClinicalTrials.gov Identifier: NCT04562428
Recruitment Status : Enrolling by invitation
First Posted : September 24, 2020
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
China Medical University Hospital

Study Description
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Brief Summary:
The purpose of the study was search the safety and efficacy of the of Xiang Sha Liu Jun Zi Decoction (XSLJZ) in advanced hepatocellular carcinoma patients with multiple protein kinase inhibitor therapy. Evaluate the treatment effect on the symptoms of appetite and quality of life in advanced hepatocellular carcinoma patients

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Xiang Sha Liu Jun Zi Decoction dry powder Drug: XSLJZ Placebo Phase 4

Detailed Description:

Hepatocellular carcinoma (HCC) is the top fourth most common cancer in Taiwan. Approximately 85% of cases of HCC patients had chronic HBV or HCV infection in Taiwan. Metabolic risk factors, such as obesity, fatty liver, high lipidemia, and diabetes mellitus are associated with increased risk for nonviral hepatocellular carcinoma.

The first and second-line systemic therapy approved in advanced hepatocellular carcinoma are multikinase inhubitors .Sorafenib (Nexavar)、Regorafenib and Lenvatinib are significantly improve survival in patients who had unresectable advanced and/or metastatic HCC not amenable to local treatment methods. General fatigue, poor appetite and pain are regarded as common and unavoidable side effect experienced during the course of cancer and its treatment. Anorexia is a common cause of malnutrition and is associated with negative effects on the quality of life (QOL) for patients with cancer. However, quality of life as a prognostic factor for survival in hepatocellular carcinoma. Management of appetite is the key to improving both the QOL and the prognosis for such patients.

Cancer-related anorexia and target therapy-induced anorexia is very important in HCC patients. According to Chinese medicine theory., "spleen-deficiency, qi-stagnation and dampness" are the most common syndrome in advanced hepatocellular carcinoma patients. Thus, the principles of Chinese medicine treatment are invigorating Pi, regulating qi, dissipating dampness and appetizing wei. Most patients received traditional Chinese medicine treatment as adjuvant therapy to alleviate cancer symptoms, diminishing the side effects and complications of treatment course at late stages. The purpose of the study was search the safety and efficacy of the of Xiang Sha Liu Jun Zi Decoction (XSLJZ) in advanced hepatocellular carcinoma patients with multiple protein kinase inhibitor therapy. Evaluate the treatment effect on the symptoms of appetite and quality of life in advanced hepatocellular carcinoma patients

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy Evaluation of XSLJZ in Advanced Hepatocellular Carcinoma Patients With Multiple Protein Kinase Inhibitor Therapy: A Randomized, Double-Blind, Controlled Trial
Actual Study Start Date : November 20, 2020
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : May 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: XSLJZ
Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid
 Drug: Xiang Sha Liu Jun Zi Decoction dry powder
the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
Placebo Comparator: XSLJZ Placebo
10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid
 Drug: XSLJZ Placebo
XSLJZ Placebo


Outcome Measures
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Primary Outcome Measures :
  1. body weight [ Time Frame: 8 weeks ]
    patient body weight

  2. EORTC QLQ-C30 score [ Time Frame: 8 weeks ]
    European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score

  3. EORTC QLQ-HCC18 [ Time Frame: 8 weeks ]
    European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score

  4. CASQ [ Time Frame: 8 weeks ]
    cancer appetite and symptom questionnaire

  5. FACT-G [ Time Frame: 8 weeks ]
    Functional Assessment of Cancer Therapy - General


Secondary Outcome Measures :
  1. CCMQ [ Time Frame: 8 weeks ]
    Chinese medicine questionnaire

  2. tong diagnosis [ Time Frame: 8 weeks ]
    tong diagnosis by Automatic Tongue Diagnosis System

  3. pulse diagnosis [ Time Frame: 8 weeks ]
    pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Advanced hepatocellular carcinoma patient
  2. use multiple protein kinase inhibitor therapy paid by National Health Care Insurance system (NHCIS) in Taiwan
  3. Child-Pugh A class
  4. Eastern Cooperative Oncology Group performance status of 0-2
  5. survival period over 3 months
  6. used Xiang Sha Liu Jun Zi Decoction for one month before the multiple protein kinase inhibitor therapystarting point

Exclusion Criteria:

  1. combine other cancer at the same time
  2. ESRD under dialysis
  3. heart disease,CHF、CAD、arrhythmia、hypertension (SBP>150mmHg，DSP>90 mmHg)
  4. current serious infection
  5. GI bleeding within 30 days
  6. receive organ transplant
  7. Child-Pugh Class B or C liver status。
  8. Refractory Ascites in Liver Cirrhosis
Contacts and Locations
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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): NCT04562428


Locations
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Taiwan
China Medical University hospital
Taichung, 西屯區, Taiwan, 407
Sponsors and Collaborators
China Medical University Hospital
Investigators
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Principal Investigator: YuanChing Liao China Medial University
More Information
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Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT04562428    
Other Study ID Numbers: CMUH109-REC1-085
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: December 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China Medical University Hospital:
Hepatocellular Carcinoma
multiple protein kinase inhibitor therapy
Xiang Sha Liu Jun Zi Decoction
appetite
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