Clinical trial NCT06381960: Clinical Study on the Prevention and Treatment of Postoperative Metastasis of Lung Cancer by Fuzheng Quxie Recipe
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Lung Cancer
Lead sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival, DFS
timeFrame: Checks were performed before the start of treatment and every 6 months after the procedure. Observational follow-up until 5 years postoperatively.
Secondary outcomes:
measure: Overall survival,OS
timeFrame: The follow-up was observed until 5 years postoperatively, and overall and median survival calculations were performed.
measure: Minimal residual disease, MRD
timeFrame: One test was performed before and 6 months after the intervention.
measure: Circulating Tumour Cell Assay
timeFrame: One test was performed before and 6 months after the intervention.
measure: Chinese Medicine Symptom Score
timeFrame: Recorded once before and once 6 months after the intervention, continuing for 18 months.
measure: Quality of life assessment
timeFrame: Recorded once before and once 6 months after the intervention, continuing for 18 months.
measure: Cellular immunity (CD3）
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: Cellular immunity (CD4)
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: Cellular immunity (CD8)
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: Cellular immunity (CD16)
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: Cellular immunity (CD56）
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: regulatory T cells
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: myeloid-derived suppressor cells （MDSCs）
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: natural killer （NK）cells
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: IL-1
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: IL-2
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: IL-6
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: IL-8
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: IL-10
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: CEA
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: CA125
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: CA153
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: Cyfra21-1
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: SCC
timeFrame: The test was performed once before the intervention and once 6 months after the intervention,continuing for 18 months.
measure: Peripheral blood systemic immunoinflammatory index
timeFrame: The test was performed once before the intervention and once 6 months after the intervention, continuing for 18 months.
Other outcomes:
Locations:
city: Changning
country: China
facility: Shanghai Chest Hospital
state: Shanghai
city: Hongkou
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Hongkou
country: China
facility: Shanghai Traditional Chinese Medicine-Integrated Hospital
state: Shanghai
city: Jing'an
country: China
facility: Shanghai Municipal Hospital of Traditional Chinese Medicine
state: Shanghai
city: Yangpu
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Jianhui Tian, professor
role: STUDY_DIRECTOR
References: