Early Stage Lung AdenocarcinomaNCT06387134
Lifei Xiaoji Wan Treatment's of Early-stage NSCLC and Its Impact on the Tumor Microenvironment
A study testing Lifei Xiaoji Wan and Conventional treatment with Western medicine in people with Early Stage Lung Adenocarcinoma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Early Stage Lung Adenocarcinoma
- 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?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 May 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- It met the diagnostic criteria of non-small cell lung cancer and was confirmed by pathology, cytology and other relevant examinations.
- Preoperative thin-slice CT showed pure ground glass pulmonary nodules with a size of 10mm-30mm. Intraoperative and postoperative pathology indicated adenocarcinoma, and the tumor stage (TNM) was stage Ia.
- Age: 18-75 years old
- Expected survival >5 years
- Informed consent and sign informed consent
Who cannot join
- Patients who have undergone surgery
- Patients with serious dysfunction of heart, liver, lung, kidney and other important organs
- Patients with mental illness who were unable to complete the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mingli Zhao
Zhengzhou
Mingli Zhao, MD, 0371-66246152, 13937159120@163.com
About this study
Official title: Study on the Therapeutic Effect of Lifei Xiaoji Wan on Lung Adenocarcinoma in the Early Stage of Ground Glass Nodule (Ia Stage) and Its Effect on Tumor Microenvironment
This study evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine
Read the detailed description
Lung cancer is a malignant tumor with the highest morbidity and mortality. The microenvironment of tumor plays an important role in its occurrence and development.Traditional Chinese medicine has great advantages in the prevention and treatment of ground glass pulmonary nodules, but there is a lack of high-level clinical evaluation evidence and precise mechanism of action.Lifei Xiaoji Wan is a prescription based on the theory of "gas accumulation causing cancer". It has good curative effect in treating non-small cell lung cancer.
In this study, a single-center randomized controlled study was used to set up a treatment group and a control group to observe and evaluate the clinical efficacy of Lifeixiaoji pills on patients with early stage lung adenocarcinoma of ground glass nodules. Flow cytometry, PCR array and multiple fluorescence immunofluorescence were used to detect the tumor microenvironment in lung cancer tissues. To investigate the effect of Lifeixiaoji pill on tumor microenvironment and its mechanism of action on early lung adenocarcinoma.
- Conditions
- Early Stage Lung Adenocarcinoma
- Being tested
- Lifei Xiaoji Wan, Conventional treatment with Western medicine
- Keywords
- early stage lung adenocarcinoma, tumor microenvironment, ground glass nodule
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 medicineDrug
Recommended treatment protocols for patients with Stage Ia NSCLC in the "Chinese Society of Oncology Branch of Lung Cancer Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2021 edition)" and the "Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Diagnosis and Treatment Guidelines 2021".
| 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 |
| control group | Placebo comparator | The patients in the control group received routine Western medicine treatments. Receives: Drug: Conventional treatment with Western medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Quality of Life Scale (FACT-L)
FACT-L scale was used to record the patients' physiological status, social/family status, emotional status and functional status
Measured: There are 36 items in the scale, and each item is scored as 0~4 points, with a total score range of 0-144 points (minimum: 0 points; maximum value: 144 points).Higher dimensions and total scores indicate higher.Change from baseline at month 1 and 2.
TCM symptoms and syndromes
The evaluation was carried out according to the standard of TCM syndrome of lung cancer in Guiding Principles for Clinical Research of New Chinese Medicine
Measured: Change from baseline at month 1 and 2.
Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body
The changes of tumor body and lesion were observed and the therapeutic effect on tumor was evaluated
Measured: Every 1 month, assessed up to 2 months, CT was collected for imaging analysis and measurement.RECIST criteria for tumor efficacy evaluation:The extent of growth or shrinkage of the target lesion (unit: mm).
Secondary outcomes (10)
Tumor markers：CEA
Tumor marker CEA levels.
Measured: Every 1 month, assessed up to 2 months.
Tumor markers：CA211
Tumor marker CA211 levels.
Measured: Every 1 month, assessed up to 2 months.
Tumor markers：squamous cell carcinoma antigen
Tumor marker squamous cell carcinoma antigen levels.
Measured: Every 1 month, assessed up to 2 months.
Complete blood count: white blood cells
white blood cells levels.
Measured: Every 1 month, assessed up to 2 months.
Complete blood count: haemoglobin
haemoglobin levels.
Measured: Every 1 month, assessed up to 2 months.
Complete blood count: Platelet
Platelet levels.
Measured: Every 1 month, assessed up to 2 months.
Liver function tests: ALT
Liver function tests ALT levels.
Measured: Every 1 month, assessed up to 2 months.
Liver function tests: AST
Liver function tests AST levels.
Measured: Every 1 month, assessed up to 2 months.
Renal function tests: BUN
Renal function tests BUN levels.
Measured: Every 1 month, assessed up to 2 months.
Renal function tests: Cr
Renal function tests Cr levels.
Measured: Every 1 month, assessed up to 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 Dec 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Lung AdenocarcinomaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 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
- NCT06387134
- Sponsor's protocol ID
- TCM for early-stage LUAD
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 26 Apr 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Therapeutic Effect of Lifei Xiaoji Wan on Lung Adenocarcinoma in the Early Stage of Ground Glass Nodule (Ia Stage) and Its Effect on Tumor Microenvironment
- ClinicalTrials.gov ID
- NCT06387134
- Acronym / sponsor ID
- TCM for early-stage LUAD
- Conditions
- Early Stage Lung Adenocarcinoma
- Keywords
- early stage lung adenocarcinoma, tumor microenvironment, ground glass nodule
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 26 Apr 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 evaluated the relationship between the clinical efficacy, histopathological changes and tumor microenvironment of the pharmacopharmacologic Lifei Xiaoji Wan in the treatment of early stage lung adenocarcinoma, and improved high-level clinical evidence and action targets for the prevention and treatment of early stage lung cancer by traditional Chinese medicine
Detailed description
Lung cancer is a malignant tumor with the highest morbidity and mortality. The microenvironment of tumor plays an important role in its occurrence and development.Traditional Chinese medicine has great advantages in the prevention and treatment of ground glass pulmonary nodules, but there is a lack of high-level clinical evaluation evidence and precise mechanism of action.Lifei Xiaoji Wan is a prescription based on the theory of "gas accumulation causing cancer". It has good curative effect in treating non-small cell lung cancer.
In this study, a single-center randomized controlled study was used to set up a treatment group and a control group to observe and evaluate the clinical efficacy of Lifeixiaoji pills on patients with early stage lung adenocarcinoma of ground glass nodules. Flow cytometry, PCR array and multiple fluorescence immunofluorescence were used to detect the tumor microenvironment in lung cancer tissues. To investigate the effect of Lifeixiaoji pill on tumor microenvironment and its mechanism of action on early lung adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | Experimental | Drug: Lifei Xiaoji WanThe patients in the trial group received routine Western medicine treatments, and oral Lifei Xiaoji Wan (10 pills/time,3 times/day). |
| control group | Placebo comparator | Drug: Conventional treatment with Western medicineThe patients in the control group received routine Western medicine treatments. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- It met the diagnostic criteria of non-small cell lung cancer and was confirmed by pathology, cytology and other relevant examinations.
- Preoperative thin-slice CT showed pure ground glass pulmonary nodules with a size of 10mm-30mm. Intraoperative and postoperative pathology indicated adenocarcinoma, and the tumor stage (TNM) was stage Ia.
- Age: 18-75 years old
- Expected survival >5 years
- Informed consent and sign informed consent
Key exclusion criteria (3 listed)
- Patients who have undergone surgery
- Patients with serious dysfunction of heart, liver, lung, kidney and other important organs
- Patients with mental illness who 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 medicineRecommended treatment protocols for patients with Stage Ia NSCLC in the "Chinese Society of Oncology Branch of Lung Cancer Clinical Diagnosis and Treatment Guidelines for Lung Cancer (2021 edition)" and the "Chinese Society of Clinical Oncology (CSCO) Non-small Cell Lung Cancer Diagnosis and Treatment Guidelines 2021". | Drug | control group |
Primary outcome
Lung Cancer Quality of Life Scale (FACT-L)
Time frame: There are 36 items in the scale, and each item is scored as 0~4 points, with a total score range of 0-144 points (minimum: 0 points; maximum value: 144 points).Higher dimensions and total scores indicate higher.Change from baseline at month 1 and 2.
FACT-L scale was used to record the patients' physiological status, social/family status, emotional status and functional status
TCM symptoms and syndromes
Time frame: Change from baseline at month 1 and 2.
The evaluation was carried out according to the standard of TCM syndrome of lung cancer in Guiding Principles for Clinical Research of New Chinese Medicine
Evaluation of tumor efficacy using RECIST criteria to measure changes in tumor body
Time frame: Every 1 month, assessed up to 2 months, CT was collected for imaging analysis and measurement.RECIST criteria for tumor efficacy evaluation:The extent of growth or shrinkage of the target lesion (unit: mm).
The changes of tumor body and lesion were observed and the therapeutic effect on tumor was evaluated
10 secondary outcomes
Tumor markers：CEA
Time frame: Every 1 month, assessed up to 2 months.
Tumor markers：CA211
Time frame: Every 1 month, assessed up to 2 months.
Tumor markers：squamous cell carcinoma antigen
Time frame: Every 1 month, assessed up to 2 months.
Complete blood count: white blood cells
Time frame: Every 1 month, assessed up to 2 months.
Complete blood count: haemoglobin
Time frame: Every 1 month, assessed up to 2 months.
Complete blood count: Platelet
Time frame: Every 1 month, assessed up to 2 months.
Liver function tests: ALT
Time frame: Every 1 month, assessed up to 2 months.
Liver function tests: AST
Time frame: Every 1 month, assessed up to 2 months.
Renal function tests: BUN
Time frame: Every 1 month, assessed up to 2 months.
Renal function tests: Cr
Time frame: Every 1 month, assessed up to 2 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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 Early Stage Lung Adenocarcinoma, 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 5 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 26 Apr 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. 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.
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 Mingli Zhao, MD (0371-66246152, 13937159120@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer Quality of Life Scale (FACT-L) (time frame: There are 36 items in the scale, and each item is scored as 0~4 points, with a total score range of 0-144 points (minimum: 0 points; maximum value: 144 points).Higher dimensions and total scores indicate higher.Change from baseline at month 1 and 2.). 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 26 Apr 2024.