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

Jianhui Tian

Status and phase: Enrolling; Phase 2

Conditions: Lung Cancer

Treatments: Drug: Fuzhengquye Fang Recipe simulant; Drug: Fuzheng Quxie Recipe

Study type: Interventional

Funder types: Other

Identifiers

NCT06381960

2022LJ014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 356 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

356 participants in 2 patient groups, including a placebo group

Daily Chinese medicine placebo granules + regular chemotherapy;

Placebo Comparator group

Description:

Control group

Treatment:

Drug: Fuzhengquye Fang Recipe simulant

Daily Fuzheng Quxie Recipe granules + regular chemotherapy

Experimental group

Description:

Treatment Group

Treatment:

Drug: Fuzheng Quxie Recipe