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

December 9, 2021 updated by: China Medical University Hospital
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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • 西屯區
      • Taichung, 西屯區, Taiwan, 407
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight
Time Frame: 8 weeks
patient body weight
8 weeks
EORTC QLQ-C30 score
Time Frame: 8 weeks
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score
8 weeks
EORTC QLQ-HCC18
Time Frame: 8 weeks
European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score
8 weeks
CASQ
Time Frame: 8 weeks
cancer appetite and symptom questionnaire
8 weeks
FACT-G
Time Frame: 8 weeks
Functional Assessment of Cancer Therapy - General
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CCMQ
Time Frame: 8 weeks
Chinese medicine questionnaire
8 weeks
tong diagnosis
Time Frame: 8 weeks
tong diagnosis by Automatic Tongue Diagnosis System
8 weeks
pulse diagnosis
Time Frame: 8 weeks
pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: YuanChing Liao, China Medial University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 20, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ANTICIPATED)

May 30, 2022

Study Registration Dates

First Submitted

September 17, 2020

First Submitted That Met QC Criteria

September 23, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2021

Last Update Submitted That Met QC Criteria

December 9, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH109-REC1-085

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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