Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe
NCT ID: NCT06381960
Last Updated: 2024-05-03
Study Results
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Basic Information
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RECRUITING
PHASE2
356 participants
INTERVENTIONAL
2023-03-01
2025-12-31
Brief Summary
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Detailed Description
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1. 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;
2. 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.
3. 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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Daily Chinese medicine placebo granules + regular chemotherapy;
Control group
Fuzhengquye Fang Recipe simulant
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.
Daily Fuzheng Quxie Recipe granules + regular chemotherapy
Treatment Group
Fuzheng Quxie Recipe
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.
Interventions
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Fuzheng Quxie Recipe
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 simulant
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Negative driver gene expression (no EGFR, ALK, ROS1 mutations) and PD-1/L1 expression \<1%;
3. 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;
4. Patients aged between 18-75 years;
5. 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);
6. Tumour PS score ≤2 and no other serious comorbidities;
7. The subjects themselves were well informed and agreed to participate in the study by signing an informed consent form and had good compliance;
8. Non-pregnant and lactating patients;
9. Passing the chemotherapy-related indexes;
10. No allergic reaction to the ingredients in the formula.
Exclusion Criteria
2. Patients who are being treated with other drugs or therapies (including other Chinese herbal medicines, immunological drugs, radiotherapy, etc.);
3. Patients who are themselves mentally ill and have a lack of autonomous behaviour;
4. Women who are pregnant, preparing for pregnancy or breastfeeding;
5. Combined heart, lung, brain, liver, kidney and haematopoietic system and other serious diseases, psychiatric patients;
6. Allergic or known hypersensitivity to the components of the drug;
7. Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months;
8. Alcohol and/or psychoactive substances abuse, drug abusers and dependent persons;
9. 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.
18 Years
75 Years
ALL
No
Sponsors
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Jianhui Tian
OTHER
Responsible Party
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Jianhui Tian
professor
Principal Investigators
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Jianhui Tian, professor
Role: STUDY_DIRECTOR
Shanghai University of Traditional Chinese Medicine
Locations
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Shanghai Chest Hospital
Changning, Shanghai Municipality, China
Shanghai General Hospital
Hongkou, Shanghai Municipality, China
Shanghai Traditional Chinese Medicine-Integrated Hospital
Hongkou, Shanghai Municipality, China
Shanghai Municipal Hospital of Traditional Chinese Medicine
Jing’an, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Yangpu, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Wentao Fang, professor
Role: primary
Qian Huang, professor
Role: primary
Yi Zhong, professor
Role: primary
Lei Jiang, professor
Role: primary
References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2022LJ014
Identifier Type: -
Identifier Source: org_study_id
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