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

NCT04562428 | Completed Phase 4

• 1 other identifier: CMUH109-REC1-085
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; multiple protein kinase inhibitor therapy; Xiang Sha Liu Jun Zi Decoction; appetite

Outcome Measures

Primary Outcomes (5)

• body weight

  patient body weight

  8 weeks

• EORTC QLQ-C30 score

  European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score

  8 weeks

• EORTC QLQ-HCC18

  European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score

  8 weeks

• CASQ

  cancer appetite and symptom questionnaire

  8 weeks

• FACT-G

  Functional Assessment of Cancer Therapy - General

  8 weeks

Secondary Outcomes (3)

• CCMQ

  8 weeks

• tong diagnosis

  8 weeks

• pulse diagnosis

  8 weeks

Study Arms (2)

XSLJZ

EXPERIMENTAL

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

Drug: Xiang Sha Liu Jun Zi Decoction dry powder

XSLJZ Placebo

PLACEBO COMPARATOR

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

Drug: XSLJZ Placebo

Interventions

Xiang Sha Liu Jun Zi Decoction dry powder DRUG

the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei

XSLJZ

XSLJZ Placebo DRUG

XSLJZ Placebo

XSLJZ Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University hospital

Taichung, 西屯區, 407, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• YuanChing Liao

  China Medial University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 24, 2020
• Study Start: November 20, 2020
• Primary Completion: December 31, 2020
• Study Completion: May 30, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

TW (1)