Hepatocellular CarcinomaPhase 4NCT04562428
The Safety and Efficacy Evaluation of XSLJZ in Advanced Hepatocellular Carcinoma Patients With Multiple Protein Kinase Inhibitor Therapy: A Randomized, Double-Blind, Controlled Trial
A Phase 4 study testing Xiang Sha Liu Jun Zi Decoction dry powder in people with Hepatocellular Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Xiang Sha Liu Jun Zi Decoction dry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Nov 2020to 30 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Xiang Sha Liu Jun Zi Decoction dry powder, XSLJZ Placebo
- Keywords
- Hepatocellular Carcinoma, multiple protein kinase inhibitor therapy, Xiang Sha Liu Jun Zi Decoction, appetite
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiang Sha Liu Jun Zi Decoction dry powderDrug
the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
XSLJZ PlaceboDrug
XSLJZ Placebo
| Study group | Role | What they receive |
|---|---|---|
| XSLJZ | Experimental | Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid Receives: 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 Receives: Drug: XSLJZ Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
body weight
patient body weight
Measured: 8 weeks
EORTC QLQ-C30 score
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score
Measured: 8 weeks
EORTC QLQ-HCC18
European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score
Measured: 8 weeks
CASQ
cancer appetite and symptom questionnaire
Measured: 8 weeks
FACT-G
Functional Assessment of Cancer Therapy - General
Measured: 8 weeks
Secondary outcomes (3)
CCMQ
Chinese medicine questionnaire
Measured: 8 weeks
tong diagnosis
tong diagnosis by Automatic Tongue Diagnosis System
Measured: 8 weeks
pulse diagnosis
pulse diagnosis by Huang's Sphygmography in Frequeny-domained Parameters
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start20 Nov 2020
- Primary completion31 Dec 2020
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YuanChing Liao, Principal investigator, China Medial University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562428
- Sponsor's protocol ID
- CMUH109-REC1-085
- Status last verified
- May 2024
- First submitted
- 17 Sep 2020
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04562428
- Acronym / sponsor ID
- CMUH109-REC1-085
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, multiple protein kinase inhibitor therapy, Xiang Sha Liu Jun Zi Decoction, appetite
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XSLJZ | Experimental | Drug: Xiang Sha Liu Jun Zi Decoction dry powderXiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid |
| XSLJZ Placebo | Placebo comparator | Drug: XSLJZ Placebo10%Xiang Sha Liu Jun Zi Decoction dry powder 7.5g/day tid |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xiang Sha Liu Jun Zi Decoction dry powderthe principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei | Drug | XSLJZ |
| XSLJZ PlaceboXSLJZ Placebo | Drug | XSLJZ Placebo |
Primary outcome
body weight
Time frame: 8 weeks
patient body weight
EORTC QLQ-C30 score
Time frame: 8 weeks
European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire score
EORTC QLQ-HCC18
Time frame: 8 weeks
European Organization for Research and Treatment of Hepatocellular carcinoma Core Quality of Life Questionnaire score
CASQ
Time frame: 8 weeks
cancer appetite and symptom questionnaire
FACT-G
Time frame: 8 weeks
Functional Assessment of Cancer Therapy - General
3 secondary outcomes
CCMQ
Time frame: 8 weeks
tong diagnosis
Time frame: 8 weeks
pulse diagnosis
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
YuanChing Liao principal investigator
China Medial University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xiang Sha Liu Jun Zi Decoction dry powder in people with Hepatocellular Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: 8 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.