Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Fuzhengquye Fang Recipe simulant; Drug: Fuzheng Quxie Recipe

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.

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.

• Study Type: Interventional
• Enrollment (Estimated): 356
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianhui Tian, Professor; Phone Number: +8613816562972; Email: tjhhawk@shutcm.edu.cn

Study Locations

• China
  • Shanghai
    • Changning, Shanghai, China
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Fan Xu; Phone Number: +8618762866303; Email: 1183596839@qq.com
      • Contact: Wentao Fang, professor
    • Hongkou, Shanghai, China
      • Recruiting
      • Shanghai General Hospital
      • Contact: Fan Xu, Dr; Phone Number: 18762866303; Email: 1183596839@qq.com
      • Contact: Qian Huang, professor
    • Hongkou, Shanghai, China
      • Recruiting
      • Shanghai Traditional Chinese Medicine-Integrated Hospital
      • Contact: Yi Zhong, professor
      • Contact: Fan Xu, Dr; Phone Number: +8618762866303; Email: 1183596839@qq.com
    • Jing'an, Shanghai, China, 200071
      • Recruiting
      • Shanghai Municipal Hospital of Traditional Chinese Medicine
      • Contact: Jianhui Tian, Professor; Phone Number: +8613816562972; Email: tjhhawk@shutcm.edu.cn
      • Contact: Fan Xu, Dr; Phone Number: 18762866303; Email: 1183596839@qq.com
    • Yangpu, Shanghai, China
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Fan Xu, Dr; Phone Number: +8618762866303; Email: 1183596839@qq.com
      • Contact: Lei Jiang, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients with clinical stage IIA-IIIA lung adenocarcinoma after radical surgery (patients within 6 weeks after surgery);
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:

1. Patients who are incompletely resected or whose cancer has undergone recurrence or metastasis;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Daily Chinese medicine placebo granules + regular chemotherapy; Control group	Drug: 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 Names: no other names
Experimental: Daily Fuzheng Quxie Recipe granules + regular chemotherapy; Treatment Group	Drug: 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.; Other Names: Fuzheng Quxie Formula；Yifei Sanjie Recipe；Yifei Sanjie Formula；

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.
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.
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.

Collaborators and Investigators

• Sponsor: Jianhui Tian
• Investigators: Study Director: Jianhui Tian, professor, Shanghai University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Estimated): May 3, 2024
• Last Update Submitted That Met QC Criteria: May 1, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 2022LJ014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No