Unresectable Hepatocellular CarcinomaNCT06315101
Effectiveness and Safety of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma: A Real-world Study in China
An observational study of Unresectable Hepatocellular Carcinoma, run by Guangzhou University of Chinese Medicine at 1 site in China.
Trial summary
This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma
- What is being tested?
- Chinese Herbal Medicine
- How many people
- 142 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2023
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this retrospective cohort study, we collected data on consecutive patients with unresectable hepatocellular carcinoma from the electronic medical records at the First Affiliated Hospital of Guangzhou University of Chinese Medicine in China, covering the period from September 2018 to July 2022, and conducted follow-ups until May 30, 2023. All cases underwent lenvatinib combined with CHM as first-line therapy, with or without PD-1 inhibitors.
Who may be able to join
- at least 18 years old
- histologically confirmed HCC unsuitable for resection
- lenvatinib as first- or second-line therapy
Who cannot join
- patients with other primary tumors
- patients who had only one visit record and were lost to follow-up or refused follow-up
- patients with any other factors affecting study data collection
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510407
About this study
Official title: A Real-world Study of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma
This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.
Read the detailed description
Liver resection is one of the most important treatments for hepatocellular carcinoma (HCC). However, only a minority of patients have the opportunity to undergo surgery. The development of systemic therapy has dramatically changed the management of unresectable HCC (uHCC). And lenvatinib garners a recommendation as the primary treatment for uHCC. Many patients with uHCC in Asian countries seek complementary and alternative therapies with traditional Chinese medicine (TCM). However, the impact of lenvatinib combined with CHM on uHCC patients remains unclear. In this study, we conducted a retrospective cohort study to assess the effectiveness and safety of lenvatinib plus CHM for patients with uHCC in China.
- Conditions
- Unresectable Hepatocellular Carcinoma
- Being tested
- Chinese Herbal Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herbal MedicineDrug
Patients were treated with Chinese herbal medicine (CHM). CHM refers to the administration of a syndrome-specific herbal formula prescribed by a Traditional Chinese Medicine (TCM) physician after an uHCC diagnosis. Physicians determine the formula based on tongue and pulse examinations and personalized TCM syndromes derived from individual patient symptoms, adhering to established therapeutic principles and long-term clinical experience of physicians. The CHM formula applied in the study followed overarching TCM strategies, including reinforcing spleen qi, harmonizing liver qi, addressing blood stasis, and detoxification.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib combined with Chinese Herbal Medicine | Not described Receives: Drug: Chinese Herbal Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy outcomes
Tumor Response after 8 weeks of treatment according to the modified Response Evaluation Criteria in Solid Tumor (mRECIST)
Measured: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
Survival analysis
Kaplan-Meier estimates of overall survival (OS)
Measured: 2022/10/01-2023/12/31
Survival analysis
Kaplan-Meier estimates of progression-free survival (PFS)
Measured: 2022/10/01-2023/12/31
Secondary outcomes (1)
Adverse Events assessment
Adverse Events (AEs) were assessed following the guidelines of the Common Terminology Criteria for Adverse Events version 4.0.
Measured: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Sep 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donghua Liu, Guangzhou University of Chinese Medicine
- Investigators
- Suihui Li, postgraduate, Study director, The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315101
- Sponsor's protocol ID
- K-2023-092
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Study of Lenvatinib Combined With Chinese Herbal Medicine for Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06315101
- Acronym / sponsor ID
- K-2023-092
- Conditions
- Unresectable Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 18 Mar 2024 (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.
This study aims to assess the effectiveness and safety of lenvatinib plus Chinese Herbal Medicine (CHM) for patients with uHCC in China.
Detailed description
Liver resection is one of the most important treatments for hepatocellular carcinoma (HCC). However, only a minority of patients have the opportunity to undergo surgery. The development of systemic therapy has dramatically changed the management of unresectable HCC (uHCC). And lenvatinib garners a recommendation as the primary treatment for uHCC. Many patients with uHCC in Asian countries seek complementary and alternative therapies with traditional Chinese medicine (TCM). However, the impact of lenvatinib combined with CHM on uHCC patients remains unclear. In this study, we conducted a retrospective cohort study to assess the effectiveness and safety of lenvatinib plus CHM for patients with uHCC in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib combined with Chinese Herbal Medicine | – | Drug: Chinese Herbal Medicine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this retrospective cohort study, we collected data on consecutive patients with unresectable hepatocellular carcinoma from the electronic medical records at the First Affiliated Hospital of Guangzhou University of Chinese Medicine in China, covering the period from September 2018 to July 2022, and conducted follow-ups until May 30, 2023. All cases underwent lenvatinib combined with CHM as first-line therapy, with or without PD-1 inhibitors.
Key inclusion criteria (3 listed)
- at least 18 years old
- histologically confirmed HCC unsuitable for resection
- lenvatinib as first- or second-line therapy
Key exclusion criteria (3 listed)
- patients with other primary tumors
- patients who had only one visit record and were lost to follow-up or refused follow-up
- patients with any other factors affecting study data collection
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 |
|---|---|---|
| Chinese Herbal MedicinePatients were treated with Chinese herbal medicine (CHM). CHM refers to the administration of a syndrome-specific herbal formula prescribed by a Traditional Chinese Medicine (TCM) physician after an uHCC diagnosis. Physicians determine the formula based on tongue and pulse examinations and personalized TCM syndromes derived from individual patient symptoms, adhering to established therapeutic principles and long-term clinical experience of physicians. The CHM formula applied in the study followed overarching TCM strategies, including reinforcing spleen qi, harmonizing liver qi, addressing blood stasis, and detoxification. | Drug | Lenvatinib combined with Chinese Herbal Medicine |
Primary outcome
Efficacy outcomes
Time frame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
Tumor Response after 8 weeks of treatment according to the modified Response Evaluation Criteria in Solid Tumor (mRECIST)
Survival analysis
Time frame: 2022/10/01-2023/12/31
Kaplan-Meier estimates of overall survival (OS)
Survival analysis
Time frame: 2022/10/01-2023/12/31
Kaplan-Meier estimates of progression-free survival (PFS)
1 secondary outcome
Adverse Events assessment
Time frame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine
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 18 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Suihui Li, postgraduate study director
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Hepatocellular Carcinoma, run by Guangzhou University of Chinese Medicine at 1 site in China.
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 3 inclusion and 3 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 18 Mar 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Efficacy outcomes (time frame: after 8 weeks of the initiation of Lenvatinib combined with Chinese Herbal Medicine). The study lists 3 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 18 Mar 2024.