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

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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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

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Xiang Sha Liu Jun Zi Decoction dry powder
* Drug: XSLJZ Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced hepatocellular carcinoma patient use multiple protein kinase inhibitor therapy paid by National Health Care Insurance system (NHCIS) in Taiwan Child-Pugh A class Eastern Cooperative Oncology Group performance status of 0-2 survival period over 3 months used Xiang Sha Liu Jun Zi Decoction for one month before the multiple protein kinase inhibitor therapystarting point Exclusion Criteria: combine other cancer at the same time ESRD under dialysis heart disease,CHF、CAD、arrhythmia、hypertension (SBP>150mmHg，DSP>90 mmHg) current serious infection GI bleeding within 30 days receive organ transplant Child-Pugh Class B or C liver status。 Refractory Ascites in Liver Cirrhosis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XSLJZ<br>Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid | Drug: Xiang Sha Liu Jun Zi Decoction dry powder<br>* the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei<br>|
| Placebo Comparator: XSLJZ Placebo<br>10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid | Drug: XSLJZ Placebo<br>* XSLJZ Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular Carcinoma, multiple protein kinase inhibitor therapy, Xiang Sha Liu Jun Zi Decoction, appetite