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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily Chinese medicine placebo granules + regular chemotherapy; | Placebo Comparator | Control group |
|
| Daily Fuzheng Quxie Recipe granules + regular chemotherapy | Experimental | Treatment Group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fuzheng Quxie Recipe | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Checks were performed before the start of treatment and every 6 months after the procedure. Observational follow-up until 5 years postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival,OS | Endpoint indicator, defined as the time from the start of randomisation to death due to any cause. | The follow-up was observed until 5 years postoperatively, and overall and median survival calculations were performed. |
| Minimal residual disease, MRD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhui Tian, professor | Contact | +8613816562972 | tjhhawk@shutcm.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianhui Tian, professor | Shanghai University of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Recruiting | Changning | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41135941 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2022 | Apr 18, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2022 | Apr 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Fuzhengquye Fang Recipe simulant | Drug | 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. |
|
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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. |
| 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. | 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. | 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. | Recorded once before and once 6 months after the intervention, continuing for 18 months. |
| Cellular immunity (CD3) | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| Cellular immunity (CD4) | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| Cellular immunity (CD8) | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| Cellular immunity (CD16) | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| Cellular immunity (CD56) | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| regulatory T cells | Immunological indicators | 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 | 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 | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| IL-1 | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| IL-2 | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| IL-6 | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| IL-8 | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| IL-10 | Immunological indicators | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| CEA | Tumour marker | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| CA125 | Tumour marker | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| CA153 | Tumour marker | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| Cyfra21-1 | Tumour marker | The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months. |
| SCC | Tumour marker | 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. | The test was performed once before the intervention and once 6 months after the intervention, continuing for 18 months. |
| Shanghai General Hospital | Recruiting | Hongkou | Shanghai Municipality | China |
|
| Shanghai Traditional Chinese Medicine-Integrated Hospital | Recruiting | Hongkou | Shanghai Municipality | China |
|
| Shanghai Municipal Hospital of Traditional Chinese Medicine | Recruiting | Jing’an | Shanghai Municipality | 200071 | China |
|
| Shanghai Pulmonary Hospital | Recruiting | Yangpu | Shanghai Municipality | China |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |