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

Hepatocellular Carcinoma Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04562428
• Other study ID #: CMUH109-REC1-085
• Status: Completed
• Phase: Phase 4
• Start date: November 20, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: May 2024
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 30, 2023
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Taiwan	China Medical University hospital	Taichung	???

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	patient body weight	8 weeks
Primary	EORTC QLQ-C30 score	European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score	8 weeks
Primary	EORTC QLQ-HCC18	European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score	8 weeks
Primary	CASQ	cancer appetite and symptom questionnaire	8 weeks
Primary	FACT-G	Functional Assessment of Cancer Therapy - General	8 weeks
Secondary	CCMQ	Chinese medicine questionnaire	8 weeks
Secondary	tong diagnosis	tong diagnosis by Automatic Tongue Diagnosis System	8 weeks
Secondary	pulse diagnosis	pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters	8 weeks