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

China Medical University

Status and phase: Completed; Phase 4

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Xiang Sha Liu Jun Zi Decoction dry powder; Drug: XSLJZ Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04562428

CMUH109-REC1-085

Details and patient eligibility

About

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

Full 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

Enrollment: 10 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

XSLJZ

Experimental group

Description:

Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid

Treatment:

Drug: Xiang Sha Liu Jun Zi Decoction dry powder

XSLJZ Placebo

Placebo Comparator group

Description:

10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid

Treatment:

Drug: XSLJZ Placebo