Clinical trial NCT04562428: The Safety and Efficacy Evaluation of XSLJZ in Advanced Hepatocellular Carcinoma Patients With Multiple Protein Kinase Inhibitor Therapy: A Randomized, Double-Blind, Controlled Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
multiple protein kinase inhibitor therapy
Xiang Sha Liu Jun Zi Decoction
appetite
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility 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

Primary outcomes:
measure: body weight
timeFrame: 8 weeks
measure: EORTC QLQ-C30 score
timeFrame: 8 weeks
measure: EORTC QLQ-HCC18
timeFrame: 8 weeks
measure: CASQ
timeFrame: 8 weeks
measure: FACT-G
timeFrame: 8 weeks
Secondary outcomes:
measure: CCMQ
timeFrame: 8 weeks
measure: tong diagnosis
timeFrame: 8 weeks
measure: pulse diagnosis
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University hospital
state: 西屯區
Study officials:
affiliation: China Medial University
name: YuanChing Liao
role: PRINCIPAL_INVESTIGATOR
References: