Advanced Non Small Cell Lung CancerNCT06406166
Lifei Xiaoji Wan in Treatment of Advanced NSCLC
A study testing Lifei Xiaoji Wan and Conventional treatment with Western medicine in people with Advanced Non Small Cell Lung Cancer, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Non Small Cell Lung Cancer
- What is being tested?
- Lifei Xiaoji Wan and Conventional treatment with Western medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 31 Dec 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of NSCLC.
- The tumor stage (TNM) stage is from III to IV.
- 18-80 years old.
- The expected survival period is> 3 months.
Who cannot join
- Early-stage patients with prior surgery and no recurrence.
- Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
- Mental illness and other patients were unable to complete the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
Yuanyuan Wang, MD, 15837180396, 40685685@qq.com
About this study
Official title: Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC
This study is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.
Read the detailed description
Non-small cell lung cancer (NSCLC) is a disease with high morbidity and mortality, poor prognosis, and a lack of safe and effective treatment. Lifei Xiaoji Wan has significant advantages in the treatment of advanced NSCLC, but the a lack of high-level clinical evaluation evidence and accurate mechanism of action research. According to the previous animal experiments of the team, it was proved that Lifei Xiaoji Wan can significantly inhibit the tumor growth ability of lung cancer mice, and inhibit the proliferation, clonal formation, and migration ability of lung cancer cells. This topic intends to adopt the method of multicenter randomized controlled study to observe the Lifei Xiaoji Wan for advanced NSCLC patients' overall survival (OS), progression-free survival (PFS), Functional Assessment of Cancer Therapy-Lung (FACT-L), TCM symptoms and syndrome and safety, help to clarify the role of Lifei Xiaoji Wan in TCM prevention and treatment of lung cancer, can provide high-level evidence for TCM prevention and treatment of lung cancer research and clinical.
- Conditions
- Advanced Non Small Cell Lung Cancer
- Being tested
- Lifei Xiaoji Wan, Conventional treatment with Western medicine
- Keywords
- advanced non small cell lung cancer, traditional Chinese medicine, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifei Xiaoji WanDrug
The Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on
Conventional treatment with Western medicineOther
Conventional treatment with Western medicine
| Study group | Role | What they receive |
|---|---|---|
| trial group | Experimental | The patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day). Receives: Drug: Lifei Xiaoji Wan; Other: Conventional treatment with Western medicine |
| control group | No intervention | The patients in the control group received routine Western medicine treatments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from enrollment to patient death.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Progression-free survival
Time from enrollment to objective tumor progression or all-cause death.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Secondary outcomes (13)
Functional Assessment of Cancer Therapy-Lung (FACT-L)
Including the physiological status, social / family status, emotional status, functional status and additional concerns, with a total score of 0-144. The higher the score, the more severe the symptoms will be.
Measured: Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.
TCM symptoms and syndrome
The improvement of the clinical symptoms, such as cough, expectoration, chest tightness, shortness of breath, fatigue, weakness, and loss of appetite.
Measured: Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.
Response Evaluation Criteria in Solid Tumours (RECIST)
patients were collected on Computed Tomography (CT) for imaging analysis and measurement, to observe the changes of tumor bodies and lesions, and to evaluate the efficacy on tumor.
Measured: Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.
Tumor markers CEA
Peripheral blood of patients was collected to observe the changes of CEA.
Measured: Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
Tumor markers CA211
Peripheral blood of patients was collected to observe the changes of CA211.
Measured: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Tumor markers Squamous Cell Careinoma Antigen
Peripheral blood of patients was collected to observe the changes of Squamous Cell Careinoma Antigen.
Measured: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Complete blood count: White blood cells levels
white blood cells levels
Measured: Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Haemoglobin levels
haemoglobin levels
Measured: Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Platelet levels
Platelet levels
Measured: Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Liver function: ALT levels
ALT levels
Measured: Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
Liver function: AST levels
AST levels
Measured: Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
Renal function: BUN levels
BUN levels
Measured: Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
Renal function: Cr levels
Cr levels
Measured: Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 Jun 2022
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non Small Cell Lung CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406166
- Sponsor's protocol ID
- TCM for advanced NSCLC
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Lifei Xiaoji Wan in Treatment of Advanced NSCLC
- ClinicalTrials.gov ID
- NCT06406166
- Acronym / sponsor ID
- TCM for advanced NSCLC
- Conditions
- Advanced Non Small Cell Lung Cancer
- Keywords
- advanced non small cell lung cancer, traditional Chinese medicine, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 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 is to evaluate the clinical efficacy of Lifei Xiaoji Wan for advanced non-small cell lung cancer (NSCLC), establish the treatment scheme, and obtain high-quality clinical evidence.
Detailed description
Non-small cell lung cancer (NSCLC) is a disease with high morbidity and mortality, poor prognosis, and a lack of safe and effective treatment. Lifei Xiaoji Wan has significant advantages in the treatment of advanced NSCLC, but the a lack of high-level clinical evaluation evidence and accurate mechanism of action research. According to the previous animal experiments of the team, it was proved that Lifei Xiaoji Wan can significantly inhibit the tumor growth ability of lung cancer mice, and inhibit the proliferation, clonal formation, and migration ability of lung cancer cells. This topic intends to adopt the method of multicenter randomized controlled study to observe the Lifei Xiaoji Wan for advanced NSCLC patients' overall survival (OS), progression-free survival (PFS), Functional Assessment of Cancer Therapy-Lung (FACT-L), TCM symptoms and syndrome and safety, help to clarify the role of Lifei Xiaoji Wan in TCM prevention and treatment of lung cancer, can provide high-level evidence for TCM prevention and treatment of lung cancer research and clinical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Drug: Lifei Xiaoji Wan, Other: Conventional treatment with Western medicineThe patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time, 3 times/day). |
| control group | No intervention | –The patients in the control group received routine Western medicine treatments. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of NSCLC.
- The tumor stage (TNM) stage is from III to IV.
- 18-80 years old.
- The expected survival period is> 3 months.
Key exclusion criteria (3 listed)
- Early-stage patients with prior surgery and no recurrence.
- Patients with serious dysfunction of the heart, liver, heart, kidney, and other important organs.
- Mental illness and other patients were unable to complete the study.
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 |
|---|---|---|
| Lifei Xiaoji WanThe Lifei Xiaoji Wan consists of ginseng, blackhead, rhubarb, aster, forehu, and thin on | Drug | trial group |
| Conventional treatment with Western medicineConventional treatment with Western medicine | Other | trial group |
Primary outcome
Overall survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time from enrollment to patient death.
Progression-free survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.
Time from enrollment to objective tumor progression or all-cause death.
13 secondary outcomes
Functional Assessment of Cancer Therapy-Lung (FACT-L)
Time frame: Change from baseline the scores of FACT-L at month 2, 4, 6, 8, 10 and 12.
TCM symptoms and syndrome
Time frame: Change from baseline the TCM symptoms and syndrome at month 2, 4, 6, 8, 10 and 12.
Response Evaluation Criteria in Solid Tumours (RECIST)
Time frame: Change from baseline the RECIST at month 2, 4, 6, 8, 10 and 12.
Tumor markers CEA
Time frame: Change from baseline the levels of tumor markers at month 2, 4, 6, 8, 10 and 12.
Tumor markers CA211
Time frame: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Tumor markers Squamous Cell Careinoma Antigen
Time frame: Change from baseline the levels of safety indicators at month 2, 4, 6, 8, 10 and 12.
Complete blood count: White blood cells levels
Time frame: Change from baseline the levels of white blood cells at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Haemoglobin levels
Time frame: Change from baseline the levels of levels at month 2, 4, 6, 8, 10 and 12.
Complete blood count: Platelet levels
Time frame: Change from baseline the levels of Platelet at month 2, 4, 6, 8, 10 and 12.
Liver function: ALT levels
Time frame: Change from baseline the levels of ALT at month 2, 4, 6, 8, 10 and 12.
Liver function: AST levels
Time frame: Change from baseline the levels of AST at month 2, 4, 6, 8, 10 and 12.
Renal function: BUN levels
Time frame: Change from baseline the levels of BUN at month 2, 4, 6, 8, 10 and 12.
Renal function: Cr levels
Time frame: Change from baseline the levels of Cr at month 2, 4, 6, 8, 10 and 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifei Xiaoji Wan and Conventional treatment with Western medicine in people with Advanced Non Small Cell Lung Cancer, run by Henan University of Traditional 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 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuanyuan Wang, MD (0371-66248624, 40685685@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year.). The study lists 2 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 25 Sep 2024.