The Safety and Efficacy Evaluation of XSLJZ in Advanced Hepatocellular Carcinoma Patients With Multiple Protein Kinase Inhibitor Therapy: A Randomized, Double-Blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- EORTC QLQ-HCC18
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
XSLJZ
Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid
干预措施: Xiang Sha Liu Jun Zi Decoction dry powder (Drug)
XSLJZ Placebo
10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid
干预措施: XSLJZ Placebo (Drug)
结局指标
主要结局
EORTC QLQ-HCC18
时间窗: 8 weeks
European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score
CASQ
时间窗: 8 weeks
cancer appetite and symptom questionnaire
FACT-G
时间窗: 8 weeks
Functional Assessment of Cancer Therapy - General
body weight
时间窗: 8 weeks
patient body weight
EORTC QLQ-C30 score
时间窗: 8 weeks
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score
次要结局
- pulse diagnosis(8 weeks)
- CCMQ(8 weeks)
- tong diagnosis(8 weeks)