Lung CancerPhase 2NCT06381960
Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe
A Phase 2 study testing Fuzheng Quxie Recipe and Fuzhengquye Fang Recipe simulant in people with Lung Cancer, run by Jianhui Tian at 5 sites in China.
Trial summary
To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Fuzheng Quxie Recipe and Fuzhengquye Fang Recipe simulant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 5 sitesChina
- Study dates
- 1 Mar 2023to 31 Dec 2025
- Phase
- Phase 2
- 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
- Patients with clinical stage IIA-IIIA lung adenocarcinoma after radical surgery (patients within 6 weeks after surgery);
- Negative driver gene expression (no EGFR, ALK, ROS1 mutations) and PD-1/L1 expression <1%;
- Meets the diagnostic criteria for Qi-Yin Deficiency Syndrome. The primary symptoms include cough, low sputum, shortness of breath, hoarseness, weakness, and thirst without wanting to drink. Secondary symptoms include spontaneous, night sweat, dysphoria in chestpalms-soles, red tongue or tooth-marked tongue, and a weak pulse. At least two primary symptoms and one of the secondary symptoms are present;
- Patients aged between 18-75 years;
- Patients with basically normal blood and biochemical indices, etc., without serious viral or bacterial infections; patients without organ failure and serious heart disease (blood bilirubin <68 μmol/L, aspartate aminotransferase <90 IU/L, creatinine <350 μmol/L, white blood cell count >3.5 × 109/L and less than 12 × 109/L, platelet count >80 × 109/L, and (erythrocyte pressure area >0.20);
- Tumour PS score ≤2 and no other serious comorbidities;
Show all 10Show fewer
- The subjects themselves were well informed and agreed to participate in the study by signing an informed consent form and had good compliance;
- Non-pregnant and lactating patients;
- Passing the chemotherapy-related indexes;
- No allergic reaction to the ingredients in the formula.
Who cannot join
- Patients who are incompletely resected or whose cancer has undergone recurrence or metastasis;
- Patients who are being treated with other drugs or therapies (including other Chinese herbal medicines, immunological drugs, radiotherapy, etc.);
- Patients who are themselves mentally ill and have a lack of autonomous behaviour;
- Women who are pregnant, preparing for pregnancy or breastfeeding;
- Combined heart, lung, brain, liver, kidney and haematopoietic system and other serious diseases, psychiatric patients;
- Allergic or known hypersensitivity to the components of the drug;
Show all 9Show fewer
- Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months;
- Alcohol and/or psychoactive substances abuse, drug abusers and dependent persons;
- Other pathologies or conditions that, in the judgement of the investigator, have the effect of reducing the likelihood of enrolment or complicating enrolment, e.g., frequent changes in the work environment, unstable living conditions, and other conditions that predispose to loss of visits.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Shanghai Chest Hospital
Changning, Shanghai Municipality
Wentao Fang, professor
Fan Xu, +8618762866303, 1183596839@qq.com
- Recruiting
Shanghai General Hospital
Hongkou, Shanghai Municipality
Qian Huang, professor
Fan Xu, Dr, 18762866303, 1183596839@qq.com
- Recruiting
Shanghai Traditional Chinese Medicine-Integrated Hospital
Hongkou, Shanghai Municipality
Yi Zhong, professor
Fan Xu, Dr, +8618762866303, 1183596839@qq.com
- Recruiting
Shanghai Municipal Hospital of Traditional Chinese Medicine
Jing’an, Shanghai Municipality, 200071
Jianhui Tian, Professor, +8613816562972, tjhhawk@shutcm.edu.cn
Fan Xu, Dr, 18762866303, 1183596839@qq.com
- Recruiting
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality
Lei Jiang, professor
Fan Xu, Dr, +8618762866303, 1183596839@qq.com
About this study
Official title: Clinical Study on the Prevention and Treatment of Postoperative Metastasis in Stage IIA-IIIA Lung Cancer With Negative Expression of Driver Genes by Fuzheng Quxie Recipe
To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil.
Read the detailed description
In this study, investigators actively explored the establishment of a combined Chinese and Western medicine prevention and treatment programme in response to the urgent clinical need for the lack of effective diagnostic and therapeutic options for postoperative patients with stage IIA-IIIA non-small cell lung cancer who are clinically negative for the expression of driver genes.
- To objectively evaluate the efficacy of "Fuzheng Quxie Recipe" in preventing and treating postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative expression of driver genes, including its effects on disease-free survival, quality of life, and regulation of immune function of the patients, by means of a clinical study in accordance with international standards;
- To test the immunohistology, circulating tumour cells and tiny residual lesions of the patients, and to screen out the population with the advantages of Chinese medicine treatment. Based on this, investigators will establish an efficacy prediction model including the evaluation of peripheral immune function status and the expression level of circulating tumour cells, in order to improve the level of precision treatment after radical lung cancer surgery.
- Through conducting high-level clinical research in line with international standards, obtaining high-level evidence-based medical evidence, screening the advantageous populations of Chinese medicine in treating lung cancer metastasis, and forming a standardised diagnostic and treatment plan/guidelines on Chinese medicine or international guidelines on combining traditional Chinese and Western medicines for the prevention and treatment of post-surgical metastasis of lung cancer that can be promoted and applied, so as to provide a solid scientific basis for the transformation of clinical results and the development of new medicines, and to promote the improvement of the efficiency of the prevention and control of lung cancer as a whole.
- Conditions
- Lung Cancer
- Being tested
- Fuzheng Quxie Recipe, Fuzhengquye Fang Recipe simulant
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fuzheng Quxie RecipeDrug
Also called Fuzheng Quxie Formula；Yifei Sanjie Recipe；Yifei Sanjie Formula；
Treatment group: Fuzheng Quxie Recipe (Yifei Sanjie Recipe) ingredients: Sheng Huang Qi 15g, Jiao Bai Zhu 15g, Bai Fu Ling 15g, Bei Sha Shen 15g, Zhe Mai Dong 15g, Dang Shen 15g, Shu Yang Quan 15g, Xia Ku Cao 15g, Sheng Mu Li 15g, Shi Jian Chuan 15g, Shi Shang Bai 15g, and Hai Zao 15g. Combined with basic chemotherapy after lung cancer.
Fuzhengquye Fang Recipe simulantDrug
Also called no other names
Control group: Fuzhengquye Fang Recipe simulant, which was prepared into control group placebo drug according to 5% of the drug content in the treatment group. Combined with basic chemotherapy after lung cancer.
| Study group | Role | What they receive |
|---|---|---|
| Daily Chinese medicine placebo granules + regular chemotherapy; | Placebo comparator | Control group Receives: Drug: Fuzhengquye Fang Recipe simulant |
| Daily Fuzheng Quxie Recipe granules + regular chemotherapy | Experimental | Treatment Group Receives: Drug: Fuzheng Quxie Recipe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival, DFS
Refers to the time between the start of randomisation and disease relapse or (for any reason) death. Imaging examination: chest CT examination before the beginning of treatment and every 6 months after the operation. Patients found to have recurrent metastases were discharged from the group for standardised treatment when the pathological diagnosis was clear. Observation and follow-up were carried out until 5 years after the operation, and the calculation of disease-free survival rate, disease-free survival period and median survival period were carried out.
Measured: Checks were performed before the start of treatment and every 6 months after the procedure. Observational follow-up until 5 years postoperatively.
Secondary outcomes (24)
Overall survival,OS
Endpoint indicator, defined as the time from the start of randomisation to death due to any cause.
Measured: The follow-up was observed until 5 years postoperatively, and overall and median survival calculations were performed.
Minimal residual disease, MRD
Second-generation sequencing NGS method was used to detect MRD in peripheral blood of the study subjects to obtain a superior population screening model for TCM treatment.
Measured: One test was performed before and 6 months after the intervention.
Circulating Tumour Cell Assay
Specimen collection method: 10ml of venous blood was taken from the patient's middle elbow vein with EDTA blood collection tube, and the blood collection tube was repeatedly reversed for mixing, and then centrifuged at 2000g for 10min, the supernatant was retained, and in order to further remove excess cellular components, it should be centrifuged again at 8000g for 10min.The separated plasma was frozen and stored at -80℃, or was extracted immediately according to the extraction kit instructions. The remaining blood cells were added to saline to replenish 10 ml and immediately isolated from circulating tumour cells.
Measured: One test was performed before and 6 months after the intervention.
Chinese Medicine Symptom Score
According to the "Shanghai Municipal Chinese Medicine Disease Diagnosis and Treatment Routine", 10 Chinese medicine symptoms of cough, sputum, chest pain, chest tightness, shortness of breath, fatigue, loss of appetite, insomnia, dry mouth and throat and spontaneous sweating were observed, with severity scored according to 0-3, and were recorded once before the intervention and once 6 months after the intervention. Significant effect: the reduction of TCM symptom scores was greater than or equal to 70% after the intervention; Effective: the reduction of TCM symptom scores was greater than or equal to 30% and less than 70% after the intervention; Ineffective: the reduction of TCM symptom scores was less than 30% after the intervention or higher than before.
Measured: Recorded once before and once 6 months after the intervention, continuing for 18 months.
Quality of life assessment
The Quality of Survival Scale for Lung Cancer Patients EORTC QLQ-LC43 was used, which consists of EORTC QLQ-C30 (core scale) and EORTC QLQ-LC13 Th (characteristic subscale of lung cancer). It mainly scores lung cancer patients on 5 domains related to functioning, general clinical symptoms, characteristic sub-symptoms, general health status and financial difficulties, and is recorded once before and 6 months after the intervention. The score ranges for each of these five areas lie on a scale of 0-100. Higher scores on the function-related domains indicate poorer functioning of the organism; higher scores on the general clinical symptoms and characteristic sub-symptoms indicate more severe symptoms; higher scores on the general health status indicate better status; and higher scores on the economic hardship status indicate more financial hardship.
Measured: Recorded once before and once 6 months after the intervention, continuing for 18 months.
Cellular immunity (CD3）
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD4)
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD8)
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD16)
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD56）
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
regulatory T cells
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
myeloid-derived suppressor cells （MDSCs）
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
natural killer （NK）cells
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-1
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-2
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-6
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-8
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-10
Immunological indicators
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
CEA
Tumour marker
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
CA125
Tumour marker
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
CA153
Tumour marker
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cyfra21-1
Tumour marker
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
SCC
Tumour marker
Measured: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Peripheral blood systemic immunoinflammatory index
SII=peripheral blood platelet count (x10/L) x peripheral blood neutrophil count (x10/L)/peripheral blood lymphocyte count (x10%/L).
PNI:serum albumin(g/L)+lymphocyte count(10/L)x5. The critical value was calculated according to the ROC curve, and according to the critical value, the above indexes were classified into high level group and low level group.
Measured: The test was performed once before the intervention and once 6 months after the intervention, continuing for 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianhui Tian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jianhui Tian, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Investigators
- Jianhui Tian, professor, Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381960
- Sponsor's protocol ID
- 2022LJ014
- Status last verified
- May 2024
- First submitted
- 15 Mar 2024
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu F, Yang Y, Luo Y, Luo B, Yao J, Zhou Y, Li M, Wu J, Shi W, Jiang L, Huang Q, Fang W, Fang Z, Li Y, Tian J. Efficacy of Fuzheng Quxie Formula Against Postoperative Metastasis of Lung Cancer in Stage IIA-IIIA With Negative Driver Genes: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 24;14:e66342. doi: 10.2196/66342.
PubMed 41135941
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Prevention and Treatment of Postoperative Metastasis in Stage IIA-IIIA Lung Cancer With Negative Expression of Driver Genes by Fuzheng Quxie Recipe
- ClinicalTrials.gov ID
- NCT06381960
- Acronym / sponsor ID
- 2022LJ014
- Conditions
- Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Jianhui TianUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 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.
To address the clinical challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative driver gene expression, there is a lack of effective diagnostic and therapeutic measures. Based on this, investigators propose to carry out a clinical study on the prevention and treatment of postoperative metastasis of IIA-IIIA stage lung cancer with negative driver gene expression with the formula of supporting the positive and dispelling the evil.
Detailed description
In this study, investigators actively explored the establishment of a combined Chinese and Western medicine prevention and treatment programme in response to the urgent clinical need for the lack of effective diagnostic and therapeutic options for postoperative patients with stage IIA-IIIA non-small cell lung cancer who are clinically negative for the expression of driver genes.
- To objectively evaluate the efficacy of "Fuzheng Quxie Recipe" in preventing and treating postoperative metastasis in stage IIA-IIIA non-small cell lung cancer with negative expression of driver genes, including its effects on disease-free survival, quality of life, and regulation of immune function of the patients, by means of a clinical study in accordance with international standards;
- To test the immunohistology, circulating tumour cells and tiny residual lesions of the patients, and to screen out the population with the advantages of Chinese medicine treatment. Based on this, investigators will establish an efficacy prediction model including the evaluation of peripheral immune function status and the expression level of circulating tumour cells, in order to improve the level of precision treatment after radical lung cancer surgery.
- Through conducting high-level clinical research in line with international standards, obtaining high-level evidence-based medical evidence, screening the advantageous populations of Chinese medicine in treating lung cancer metastasis, and forming a standardised diagnostic and treatment plan/guidelines on Chinese medicine or international guidelines on combining traditional Chinese and Western medicines for the prevention and treatment of post-surgical metastasis of lung cancer that can be promoted and applied, so as to provide a solid scientific basis for the transformation of clinical results and the development of new medicines, and to promote the improvement of the efficiency of the prevention and control of lung cancer as a whole.
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 |
|---|---|---|
| Daily Chinese medicine placebo granules + regular chemotherapy; | Placebo comparator | Drug: Fuzhengquye Fang Recipe simulantControl group |
| Daily Fuzheng Quxie Recipe granules + regular chemotherapy | Experimental | Drug: Fuzheng Quxie RecipeTreatment Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with clinical stage IIA-IIIA lung adenocarcinoma after radical surgery (patients within 6 weeks after surgery);
- Negative driver gene expression (no EGFR, ALK, ROS1 mutations) and PD-1/L1 expression <1%;
- Meets the diagnostic criteria for Qi-Yin Deficiency Syndrome. The primary symptoms include cough, low sputum, shortness of breath, hoarseness, weakness, and thirst without wanting to drink. Secondary symptoms include spontaneous, night sweat, dysphoria in chestpalms-soles, red tongue or tooth-marked tongue, and a weak pulse. At least two primary symptoms and one of the secondary symptoms are present;
- Patients aged between 18-75 years;
- Patients with basically normal blood and biochemical indices, etc., without serious viral or bacterial infections; patients without organ failure and serious heart disease (blood bilirubin <68 μmol/L, aspartate aminotransferase <90 IU/L, creatinine <350 μmol/L, white blood cell count >3.5 × 109/L and less than 12 × 109/L, platelet count >80 × 109/L, and (erythrocyte pressure area >0.20);
Key exclusion criteria (9 listed)
- Patients who are incompletely resected or whose cancer has undergone recurrence or metastasis;
- Patients who are being treated with other drugs or therapies (including other Chinese herbal medicines, immunological drugs, radiotherapy, etc.);
- Patients who are themselves mentally ill and have a lack of autonomous behaviour;
- Women who are pregnant, preparing for pregnancy or breastfeeding;
- Combined heart, lung, brain, liver, kidney and haematopoietic system and other serious diseases, psychiatric patients;
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 |
|---|---|---|
| Fuzheng Quxie RecipeAlso: Fuzheng Quxie Formula；Yifei Sanjie Recipe；Yifei Sanjie Formula；Treatment group: Fuzheng Quxie Recipe (Yifei Sanjie Recipe) ingredients: Sheng Huang Qi 15g, Jiao Bai Zhu 15g, Bai Fu Ling 15g, Bei Sha Shen 15g, Zhe Mai Dong 15g, Dang Shen 15g, Shu Yang Quan 15g, Xia Ku Cao 15g, Sheng Mu Li 15g, Shi Jian Chuan 15g, Shi Shang Bai 15g, and Hai Zao 15g. Combined with basic chemotherapy after lung cancer. | Drug | Daily Fuzheng Quxie Recipe granules + regular chemotherapy |
| Fuzhengquye Fang Recipe simulantAlso: no other namesControl group: Fuzhengquye Fang Recipe simulant, which was prepared into control group placebo drug according to 5% of the drug content in the treatment group. Combined with basic chemotherapy after lung cancer. | Drug | Daily Chinese medicine placebo granules + regular chemotherapy; |
Primary outcome
Disease-free survival, DFS
Time frame: Checks were performed before the start of treatment and every 6 months after the procedure. Observational follow-up until 5 years postoperatively.
Refers to the time between the start of randomisation and disease relapse or (for any reason) death. Imaging examination: chest CT examination before the beginning of treatment and every 6 months after the operation. Patients found to have recurrent metastases were discharged from the group for standardised treatment when the pathological diagnosis was clear. Observation and follow-up were carried out until 5 years after the operation, and the calculation of disease-free survival rate, disease-free survival period and median survival period were carried out.
24 secondary outcomes
Overall survival,OS
Time frame: The follow-up was observed until 5 years postoperatively, and overall and median survival calculations were performed.
Minimal residual disease, MRD
Time frame: One test was performed before and 6 months after the intervention.
Circulating Tumour Cell Assay
Time frame: One test was performed before and 6 months after the intervention.
Chinese Medicine Symptom Score
Time frame: Recorded once before and once 6 months after the intervention, continuing for 18 months.
Quality of life assessment
Time frame: Recorded once before and once 6 months after the intervention, continuing for 18 months.
Cellular immunity (CD3）
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD4)
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD8)
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD16)
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cellular immunity (CD56）
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
regulatory T cells
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
myeloid-derived suppressor cells （MDSCs）
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
natural killer （NK）cells
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-1
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-2
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-6
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-8
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
IL-10
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
CEA
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
CA125
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
CA153
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Cyfra21-1
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
SCC
Time frame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
Peripheral blood systemic immunoinflammatory index
Time frame: The test was performed once before the intervention and once 6 months after the intervention, continuing for 18 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 41135941Xu F, Yang Y, Luo Y, Luo B, Yao J, Zhou Y, Li M, Wu J, Shi W, Jiang L, Huang Q, Fang W, Fang Z, Li Y, Tian J. Efficacy of Fuzheng Quxie Formula Against Postoperative Metastasis of Lung Cancer in Stage IIA-IIIA With Negative Driver Genes: Protocol for a Multicenter, Double-Blind, Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 24;14:e66342. doi: 10.2196/66342.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Jianhui Tian, professor study director
Shanghai University of Traditional Chinese Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fuzheng Quxie Recipe and Fuzhengquye Fang Recipe simulant in people with Lung Cancer, run by Jianhui Tian at 5 sites 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 10 inclusion and 9 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 3 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 5 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jianhui Tian, professor (+8613816562972, tjhhawk@shutcm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival, DFS (time frame: Checks were performed before the start of treatment and every 6 months after the procedure. Observational follow-up until 5 years postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06381960, which also lists 1 linked publication.
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 3 May 2024.