The Safety and Efficacy Evaluation of XSLJZ in Advanced Hepatocellular Carcinoma Patients With Multiple Protein Kinase Inhibitor Therapy: A Randomized, Double-Blind, Controlled Trial
NCT ID: NCT04562428
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
10 participants
INTERVENTIONAL
2020-11-20
2023-05-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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XSLJZ
Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid
Xiang Sha Liu Jun Zi Decoction dry powder
the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
XSLJZ Placebo
10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid
XSLJZ Placebo
XSLJZ Placebo
Interventions
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Xiang Sha Liu Jun Zi Decoction dry powder
the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
XSLJZ Placebo
XSLJZ Placebo
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
75 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Principal Investigators
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YuanChing Liao
Role: PRINCIPAL_INVESTIGATOR
China Medial University
Locations
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China Medical University hospital
Taichung, 西屯區, Taiwan
Countries
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Other Identifiers
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CMUH109-REC1-085
Identifier Type: -
Identifier Source: org_study_id
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