Preventing and treating lung cancer metastasis with a traditional Chinese medicine 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

This study is testing a traditional Chinese medicine recipe to see if it can help prevent lung cancer from spreading and improve the health and quality of life for patients with early-stage non-small cell lung cancer who don't have certain gene markers.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 356 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Municipal Hospital of Traditional Chinese Medicine (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 5 sites (Changning, Shanghai Municipality and 4 other locations)
• Trial ID: NCT06381960 on ClinicalTrials.gov

What this trial studies

This clinical study aims to address the challenge of postoperative metastasis in stage IIA-IIIA non-small cell lung cancer patients who do not express driver genes. Investigators will evaluate the efficacy of the Fuzheng Quxie Recipe in preventing metastasis and improving disease-free survival, quality of life, and immune function. The study will also involve testing immunohistology and circulating tumor cells to identify patients who may benefit from this combined Chinese and Western medicine approach. The goal is to establish a precision treatment model based on immune function and tumor markers.

Who should consider this trial

Good fit: Ideal candidates are patients aged 18-75 with stage IIA-IIIA lung adenocarcinoma who have undergone radical surgery and have negative driver gene expression.

Not a fit: Patients with positive driver gene expression or those with serious comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve outcomes for lung cancer patients by preventing metastasis and enhancing their quality of life.

How similar studies have performed: While the use of traditional Chinese medicine in cancer treatment is gaining interest, this specific approach is relatively novel and has not been extensively tested in similar studies.

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.

Where this trial is running

Changning, Shanghai Municipality and 4 other locations

• Shanghai Chest Hospital — Changning, Shanghai Municipality, China (Recruiting)
• Shanghai General Hospital — Hongkou, Shanghai Municipality, China (Recruiting)
• Shanghai Traditional Chinese Medicine-Integrated Hospital — Hongkou, Shanghai Municipality, China (Recruiting)
• Shanghai Municipal Hospital of Traditional Chinese Medicine — Jing’an, Shanghai Municipality, China (Recruiting)
• Shanghai Pulmonary Hospital — Yangpu, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jianhui Tian, professor

Conditions Lung Cancer