Integrating Chinese herbal medicine in advanced lung cancer: a multicenter real-world study using target trial emulation
| ISRCTN | ISRCTN78546774 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78546774 |
| Secondary identifying numbers | MOHW114-CMAP-M-113-000005-C |
- Submission date
- 04/06/2025
- Registration date
- 09/06/2025
- Last edited
- 09/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Lung cancer is the leading cause of cancer-related deaths globally, with about 2.4 million new cases and 1.8 million deaths reported in 2022. Over 75% of cases are diagnosed at advanced stages, with a 5-year survival rate of only 5.2%. Non-small cell lung cancer (NSCLC) accounts for more than 80% of lung cancers. While targeted therapies, particularly EGFR-TKIs, extend progression-free survival, they are often limited by resistance and adverse effects. Chinese herbal medicine (CHM), commonly used in Asia, has shown potential in improving outcomes and reducing treatment-related side effects in NSCLC. This study aims to evaluate the feasibility and long-term impact of integrating CHM - specifically oral CHM - into advanced NSCLC management using real-world data and network pharmacology.
Who can participate?
Patients aged 18 to 80 years diagnosed with stage IV non-small cell lung cancer who have received oral Chinese herbal medicine as part of their treatment.
What does the study involve?
This is a retrospective analysis of clinical outcomes using real-world databases. The study will also use network pharmacology to analyze core CHM prescriptions and their potential molecular mechanisms.
What are the possible benefits and risks of participating?
As this is a retrospective study, there is no direct involvement or risk to patients. The findings may benefit future patients by optimizing integrative treatment strategies.
Where is the study run from?
Chang Gung Memorial Hospital, Taiwan
When is the study starting and how long is it expected to run for?
November 2023to February 2024
Who is funding the study?
The study is funded by the Chang Gung Medical Foundation, the Ministry of Health and Welfare and the National Science and Technology Council in Taiwan.
Who is the main contact?
Dr Hsing-Yu Chen, 8705016@cgmh.org.tw
Contact information
Public, Scientific, Principal Investigator
No.123, Dinghu Rd., Guishan Dist.
Taoyuan City
33378
Taiwan
 ORCID ID |
0000-0001-7897-9851 |
|---|---|
| Phone | +886 (0)975366119 |
| 8705016@cgmh.org.tw |
Study information
| Study design | Multi-center retrospective target trial emulation |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | The clinical outcomes of integrating Chinese herbal medicine in stage IV non-small cell lung cancer treatment: a multicenter real-world study using target trial emulation and system biology approach |
| Study objectives | Integrating Chinese herbal medicine (CHM) in the management of patients with advanced non-small cell lung cancer (NSCLC) may have a better long-term outcome than standard therapy alone. |
| Ethics approval(s) |
Approved 23/11/2023, The Institutional Review Board of the Chang Gung Medical Foundation (199, Tung Hwa North Road, Taipei, 10507, Taiwan; +886 (0)3 3196200; jocelyn320@cgmh.org.tw), ref: 202300142B0C502 |
| Health condition(s) or problem(s) studied | Stage IV non-small cell lung cancer. |
| Intervention | Chinese herbal medicine, modified according to illness and physicians' clinical experience (at least 28 days of oral Chinese herbal medicine treatment, twice to three times a day). The follow-up duration was set as 10 years after diagnosis or to the date of 31/12/2021. |
| Intervention type | Supplement |
| Primary outcome measure | Overall survival (OS), retrieved from the clinical database built up by the Chang Gung Medical Foundation, measured at the end of the study (31/12/2021) or 10 years after diagnosis |
| Secondary outcome measures | Cancer-specific survival (CSS), retrieved from the clinical database built up by the Chang Gung Medical Foundation, measured at the end of the study (31/12/2021) or 10 years after diagnosis |
| Overall study start date | 13/11/2023 |
| Completion date | 13/02/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 8000 |
| Total final enrolment | 6359 |
| Key inclusion criteria | 1. Patients newly diagnosed with stage IV NSCLC 2. Aged 18 to 80 years |
| Key exclusion criteria | 1. Patients aged <18 or ≥80 years 2. Errors in diagnosis or death date 3. Missing TNM staging records 4. Non-stage IV NSCLC, or cancer types other than squamous cell (SqCC) and adenocarcinoma (AC) |
| Date of first enrolment | 01/01/2011 |
| Date of final enrolment | 31/12/2021 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taoyuan City
333
Taiwan
Sponsor information
Hospital/treatment centre
No.5, Fuxing St., Guishan Dist.
Taoyuan City
333
Taiwan
| Phone | +886 (0)3-3196200#3703 |
|---|---|
| jocelyn320@cgmh.org.tw | |
| Website | https://www.cgmh.org.tw/eng |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Taiwan
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- Taiwan
Government organisation / National government
- Alternative name(s)
- National Science and Technology Council (Taiwan), National Science and Technology Council, R.O.C, National Science and Technology Council of Taiwan, Ministry of Science and Technology, Taiwan, Taiwan's National Science and Technology Council, 國家科學及技術委員會, NSTC
- Location
- Taiwan
Results and Publications
| Intention to publish date | 31/07/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The dataset analyzed in this study would be available upon proper request and approval from the Institutional Review Board of the Chang Gung Medical Foundation |
Editorial Notes
06/06/2025: Study's existence confirmed by the Institutional Review Board of the Chang Gung Medical Foundation.
